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      • id171
      • user_id47
      • trial_status_id5
      • abstract_of_study<div>\n <p>\n <strong>Controlled Comparison of Two Moxifloxacin Containing Treatment Shortening Regimens in Pulmonary Tuberculosis (REMoxTB)</strong></p>\n</div>\n<p>\n  </p>\n<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td nowrap=\"nowrap\">\n <p>\n <strong>Official Title:</strong></p>\n </td>\n <td>\n <p>\n A Randomised Placebo - Controlled Double Blind Trial Comparing 1) a Two Month Intensive Phase of Ethambutol, Moxifloxacin, Rifampicin, Pyrazinamide Versus the Standard Regimen (Ethambutol, Isoniazid, Rifampicin, Pyrazinamide) and 2) a Treatment Shortening Regimen Comparing Two Months Moxifloxacin, Isoniazid, Rifampicin, Pyrazinamide Followed by Two Months Moxifloxacin, Isoniazid, Rifampicin Versus the Standard Regimen (Two Months Ethambutol, Isoniazid, Rifampicin, Pyrazinamide Followed by Four Months Isoniazid and Rifampicin) for the Treatment of Adults With Pulmonary Tuberculosis</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<p>\n <strong>Sponsor:</strong></p>\n<p>\n Global Alliance for TB Drug Development</p>\n<p>\n <strong>Collaborators:</strong></p>\n<p>\n European and Developing Countries Clinical Trials Partnership (EDCTP)</p>\n<p>\n University College, London</p>\n<p>\n Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma</p>\n<p>\n Sanofi</p>\n<p>\n  </p>\n<p>\n <strong>Site:</strong>  Centre for Respiratory Diseases Research, Kenya Medical Research Institute</p>\n<p>\n Current standard TB therapy is based on four medicines discovered forty or more years ago that must be administered for six to eight months, often under the direct observation of a healthcare professional (DOTS). A shorter TB treatment regimen should increase patient compliance, reduce failure rates and lower TB-related healthcare expenditures in endemic countries. REMoxTB is a study for the "Rapid Evaluation of Moxifloxacin in the treatment of sputum smear positive tuberculosis". REMoxTB aims to find and evaluate new drugs and regimens that shorten the duration of tuberculosis therapy. Preclinical studies showed that moxifloxacin could reduce treatment time by two months when substituted for isoniazid or ethambutol, two cornerstones of current TB treatment. The results of clinical phase II studies support the treatment reduction potential of moxifloxacin. Moxifloxacin is currently approved in 123 countries for the treatment of acute bacterial infections. However, Moxifloxacin is not currently approved for the treatment of TB, including multi-drug resistant TB (MDR-TB).</p>\n<p>\n The purpose of REMoxTB is to evaluate the efficacy, safety and acceptability of two moxifloxacin-containing treatment combinations to determine whether substituting ethambutol with moxifloxacin in one combination, and/or substituting isoniazid with moxifloxacin in another combination, makes it possible to reduce the duration of treatment for TB.</p>\n<p>\n The study type is interventional and the study design is a randomized double blinded whose intervention model is parallel assignment and the primary purpose is to evaluate the treatment. The primary end points are efficacy and safety.</p>\n<p>\n The study participants are patients with newly diagnosed previously untreated sputum smear positive pulmonary tuberculosis who fit the inclusion and exclusion criteria.</p>\n<p>\n The study is ongoing but no recruitment of participants.</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n
      • study_title<p>\n A randomised placebo – controlled double blind trial comparing two treatment shortening regimens with the standard regimen (two months ethambutol,<br />\n isoniazid, rifampicin and pyrazinamide followed by four months isoniazid and rifampicin) namely 1) two months moxifloxacin, isoniazid, rifampicin and<br />\n pyrazinamide followed by two months moxifloxacin, isoniazid and rifampicin and 2) two months ethambutol, moxifloxacin, rifampicin and pyrazinamide followed by<br />\n two months moxifloxacin and rifampicin for the treatment of adults with pulmonary tuberculosis</p>\n
      • laymans_summary(null)
      • short_titleREMoxTB
      • protocol_noECCT/09/03/01
      • version_no6.1
      • date_of_protocol18-08-2011
      • study_drugMoxifloxacin
      • disease_conditionPulmonary tuberculosis
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameMoxifloxacin
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressbmiheso@kemri.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantBarbara Miheso
      • declaration_date125-07-2013
      • declaration_principal_investigatorDr. Evans I. Amukoye
      • declaration_date225-07-2013
      • placebo_presentYes
      • study_objectives(null)
      • principal_inclusion_criteria<div>\n A. Signed written consent or witnessed oral consent in the case of illiteracy, before undertaking any trial related activity.</div>\n<div>\n B. Two sputum specimens positive for tubercle bacilli on smear microscopy at least one of which must be processed and positive at the study laboratory.</div>\n<div>\n C. Aged 18 years or over.</div>\n<div>\n <div>\n D. No previous anti-tuberculosis chemotherapy.</div>\n <div>\n E. A firm home address that is readily accessible for visiting and willingness to inform the study team of any change of address during the treatment and</div>\n <div>\n follow-up period.</div>\n <div>\n F. Agreement to participate in the study and to give a sample of blood for HIV testing (see appendices 1 & 2).</div>\n <div>\n G. Pre-menopausal women must be using a barrier form of contraception or be surgically sterilised or have an IUCD in place.</div>\n <div>\n H. Laboratory parameters performed up to 14 days before enrolment.</div>\n <div>\n ï‚· Serum aspartate transaminase (AST) and alanine transaminase (ALT) activity less than 3 times the upper limit of normal</div>\n <div>\n ï‚· Serum total bilirubin level less than 2.5 times upper limit of normal</div>\n <div>\n ï‚· Creatinine clearance (CrCl) level greater than 30 mls/min</div>\n <div>\n ï‚· Haemoglobin level of at least 7.0 g/dL</div>\n <div>\n ï‚· Platelet count of at least 50x109cells/L</div>\n <div>\n ï‚· Serum potassium greater than 3.5 mmol/L</div>\n <div>\n I. Negative pregnancy test (women of childbearing potential).</div>\n</div>\n<p>\n  </p>\n
      • principal_exclusion_criteria<div>\n A. Unable to take oral medication.</div>\n<div>\n B. Previously enrolled in this study.</div>\n<div>\n C. Received any investigational drug in the past 3 months.</div>\n<div>\n D. Received an antibiotic active against M. tuberculosis in the last 14 days (fluoroquinolones, macrolides, standard anti-tuberculosis drugs).</div>\n<div>\n E. Any condition that may prove fatal during the first two months of the study period.</div>\n<div>\n F. TB meningitis or other forms of severe tuberculosis with high risk of a poor outcome</div>\n<div>\n G. Pre-existing non-tuberculosis disease e.g. diabetes, liver or kidney disease, blood disorders, peripheral neuritis, chronic diarrhoeal disease in which the</div>\n<div>\n <div>\n current clinical condition of the patient is likely to prejudice the response to, or assessment of treatment.</div>\n <div>\n H. Pregnant or breast feeding.</div>\n <div>\n I. Suffering from a condition likely to lead to uncooperative behaviour e.g. psychiatric illness or alcoholism.</div>\n <div>\n J. Contraindications to any medications in the study regimens.</div>\n <div>\n K. Known to have congenital or sporadic syndromes of QTc prolongation or</div>\n <div>\n receiving concomitant medication reported to increase the QTc interval (e.g.</div>\n <div>\n amiodarone, sotalol, disopyramide, quinidine, procainamide, terfenadine).</div>\n <div>\n L. Known allergy to any fluoroquinolone antibiotic or history of tendinopathy associated with quinolones.</div>\n <div>\n M. Patients already receiving anti-retroviral therapy.</div>\n <div>\n N. Patients whose initial isolate is shown to be multiple drug resistant (i.e. resistant to rifampicin and isoniazid) or monoresistant to rifampicin, or</div>\n <div>\n resistant to any fluoroquinolone). </div>\n <div>\n O. Weight less than 35kg</div>\n <div>\n P. HIV infection with CD4 count less than 250 cells/μL.</div>\n <div>\n Q. End stage liver failure (class Child-Pugh C).</div>\n</div>\n<p>\n  </p>\n
      • primary_end_points<div>\n 1. Efficacy:</div>\n<div>\n Combined failure of bacteriological cure and relapse within one year of completion of therapy as defined by culture using solid media.</div>\n<div>\n  </div>\n<div>\n 2. Safety:</div>\n<div>\n Both comparisons: Proportion of patients with grade 3 or 4 adverse events.</div>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:1017px;\" width=\"1016\">\n <colgroup>\n <col />\n <col />\n <col />\n <col />\n <col span=\"2\" />\n <col />\n </colgroup>\n <tbody>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Nairobi - 0106</td>\n <td colspan=\"6\" style=\"width:845px;\">\n  </td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Staff Member</td>\n <td style=\"width:128px;\">\n Role</td>\n <td style=\"width:101px;\">\n INSTITUTION</td>\n <td colspan=\"4\" style=\"width:616px;\">\n Qualification</td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Dr. Evans Amukoye</td>\n <td style=\"width:128px;\">\n Principal Investigator</td>\n <td style=\"width:101px;\">\n KEMRI</td>\n <td colspan=\"4\" style=\"width:616px;\">\n MB.ChB( MD), M.Med(Pead), Clinical Fellow Pulmunology</td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Dr. Jane Ong'ang'o</td>\n <td style=\"width:128px;\">\n Co-Investigator</td>\n <td style=\"width:101px;\">\n KEMRI</td>\n <td colspan=\"4\" style=\"width:616px;\">\n MBChB, MSc in Pulblic health, Post draduate Dip. STI/HIV, PhD Epidemiology (Ongoing)</td>\n </tr>\n <tr height=\"34\">\n <td height=\"34\" style=\"height:34px;width:172px;\">\n Dr. Samoel Khamadi</td>\n <td style=\"width:128px;\">\n Co-Investigator/Lab Coodinator</td>\n <td style=\"width:101px;\">\n WRP</td>\n <td colspan=\"4\" style=\"width:616px;\">\n PhD Molecular Medicine, Post Graduate Fellow, Dip. Project Management</td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Barbara B. Miheso</td>\n <td style=\"width:128px;\">\n Study Coordinator </td>\n <td style=\"width:101px;\">\n KEMRI</td>\n <td colspan=\"4\" style=\"width:616px;\">\n Bsc Biochemistry, MSc Molecuar Medicine (ongoing), Dip. Project Management</td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Mr Paul Mwangi</td>\n <td style=\"width:128px;\">\n Clinical Officer</td>\n <td style=\"width:101px;\">\n KEMRI</td>\n <td colspan=\"4\" style=\"width:616px;\">\n MSc. Community Health Development, Higher Dip. Lung and skin, Diploma in Clinical Med.and Surgery </td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Susan Mutua</td>\n <td style=\"width:128px;\">\n Clinical Officer</td>\n <td style=\"width:101px;\">\n KEMRI</td>\n <td colspan=\"4\" style=\"width:616px;\">\n Dip. Clinical Med. And Surgery  </td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Margaret N. Karugu</td>\n <td style=\"width:128px;\">\n Nurse</td>\n <td style=\"width:101px;\">\n KEMRI</td>\n <td colspan=\"4\" style=\"width:616px;\">\n Higher Dip. Medical health and Psychological Counseling, KRN</td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Gertrude Nzoka</td>\n <td style=\"width:128px;\">\n Nurse</td>\n <td style=\"width:101px;\">\n MOH</td>\n <td colspan=\"4\" style=\"width:616px;\">\n KRN</td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Dr. Angela Amayo</td>\n <td style=\"width:128px;\">\n Biochemistry Lab </td>\n <td style=\"width:101px;\">\n UON</td>\n <td colspan=\"4\" style=\"width:616px;\">\n MBChB, Msc Med (Human Pathology), Dip. Total Quality Management</td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Dr. Julius Kuria</td>\n <td style=\"width:128px;\">\n Biochemistry Lab</td>\n <td style=\"width:101px;\">\n UON</td>\n <td colspan=\"4\" style=\"width:616px;\">\n MBChB, MSc. Human Pathology</td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Dr. Jessie Githanga</td>\n <td style=\"width:128px;\">\n Hematology</td>\n <td style=\"width:101px;\">\n UON</td>\n <td colspan=\"4\" style=\"width:616px;\">\n MBChB, MSc. Human Pathology, Pst Doc. Cytogenetics and haematology</td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Dr. Peter Maturi Mwamba</td>\n <td style=\"width:128px;\">\n Hematology</td>\n <td style=\"width:101px;\">\n UON</td>\n <td colspan=\"4\" style=\"width:616px;\">\n MBChB, HDip.Computer Science</td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Charles Namutembi</td>\n <td style=\"width:128px;\">\n Lab technologist</td>\n <td style=\"width:101px;\">\n UON</td>\n <td colspan=\"4\" style=\"width:616px;\">\n Hdip. Haematology and Blood transfusion, Dip. Medical Laboratory Technology</td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Mr. Ireri M. Jackson</td>\n <td style=\"width:128px;\">\n Lab technologist</td>\n <td style=\"width:101px;\">\n UON</td>\n <td colspan=\"4\" style=\"width:616px;\">\n MSc. Infectious Diseases Diagnosis, Hdip. Medical Laboratory Science, Dip. Medical Laboratory Science</td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Debora Mogi</td>\n <td style=\"width:128px;\">\n Lab technologist</td>\n <td style=\"width:101px;\">\n UON</td>\n <td colspan=\"4\" style=\"width:616px;\">\n HDip. Clinical Chemistry, Dip. Medical Laboratory Technology</td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Francis Wanyama</td>\n <td style=\"width:128px;\">\n Lab technologist</td>\n <td style=\"width:101px;\">\n UON</td>\n <td colspan=\"4\" style=\"width:616px;\">\n HDip. Medical Laboratory Technology, Dip. Medical Laoratory Technology</td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Joyce Maganga</td>\n <td style=\"width:128px;\">\n Lab technologist</td>\n <td style=\"width:101px;\">\n UON</td>\n <td colspan=\"4\" style=\"width:616px;\">\n HDip. Medical Laboratory Technology, Dip. Medical Laoratory Technology</td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Tabitha Mungai</td>\n <td style=\"width:128px;\">\n Lab technologist</td>\n <td style=\"width:101px;\">\n UON</td>\n <td colspan=\"4\" style=\"width:616px;\">\n HDip. Medical Laboratory Technology, Dip. Medical Laoratory Technology</td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Esther O. Adoyo</td>\n <td style=\"width:128px;\">\n Lab technologist</td>\n <td style=\"width:101px;\">\n MOH</td>\n <td colspan=\"4\" style=\"width:616px;\">\n Dip. Medical Lab. Sciences, BSc. Medical Lab Sciences( On going)</td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Jacline O. Nyaboke</td>\n <td style=\"width:128px;\">\n Lab technologist</td>\n <td style=\"width:101px;\">\n MOH</td>\n <td colspan=\"4\" style=\"width:616px;\">\n Dip. Medical Lab. Sciences </td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Geoffrey Okallo</td>\n <td style=\"width:128px;\">\n Data Manager </td>\n <td style=\"width:101px;\">\n KEMRI</td>\n <td colspan=\"4\" style=\"width:616px;\">\n Microsoft Certiffied Professional Certification, Dip. Statistics, Computer Programming</td>\n </tr>\n <tr height=\"34\">\n <td height=\"34\" style=\"height:34px;width:172px;\">\n Ednah Wanjiku</td>\n <td style=\"width:128px;\">\n Data Manager Back up </td>\n <td style=\"width:101px;\">\n KEMRI</td>\n <td colspan=\"4\" style=\"width:616px;\">\n BSc. Computing, Dip. IT, MBA. Management Information Systems </td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n M’Iti Linda Karimi</td>\n <td style=\"width:128px;\">\n Data Clerk</td>\n <td style=\"width:101px;\">\n KEMRI</td>\n <td colspan=\"4\" style=\"width:616px;\">\n BSc. IT </td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Esther Mogaka</td>\n <td style=\"width:128px;\">\n Data Clerk</td>\n <td style=\"width:101px;\">\n KEMRI</td>\n <td colspan=\"4\" style=\"width:616px;\">\n Cert. Pharmaceutical technology</td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Stella Kamande</td>\n <td style=\"width:128px;\">\n Data Clerk</td>\n <td style=\"width:101px;\">\n KEMRI</td>\n <td colspan=\"4\" style=\"width:616px;\">\n Cert. Library Studies</td>\n </tr>\n <tr height=\"34\">\n <td height=\"34\" style=\"height:34px;width:172px;\">\n Anthony Sore</td>\n <td style=\"width:128px;\">\n Community mobilizer</td>\n <td style=\"width:101px;\">\n MOH</td>\n <td colspan=\"4\" style=\"width:616px;\">\n Cert. HIV/AIDS and counselor</td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Sarah Mulera</td>\n <td style=\"width:128px;\">\n Community mobilizer</td>\n <td style=\"width:101px;\">\n MOH</td>\n <td colspan=\"4\" style=\"width:616px;\">\n Dip. Psychological Counselling, Cert. HIV Counselling and Testing</td>\n </tr>\n <tr height=\"34\">\n <td height=\"34\" style=\"height:34px;width:172px;\">\n Francis Litu Mutange</td>\n <td style=\"width:128px;\">\n Community mobilizer</td>\n <td style=\"width:101px;\">\n MOH</td>\n <td colspan=\"4\" style=\"width:616px;\">\n Cert.HIV Counselling and Testing</td>\n </tr>\n <tr height=\"34\">\n <td height=\"34\" style=\"height:34px;width:172px;\">\n Jackline Achieng' Odhiambo</td>\n <td style=\"width:128px;\">\n Pharmacist</td>\n <td style=\"width:101px;\">\n KEMRI</td>\n <td colspan=\"4\" style=\"width:616px;\">\n B. Pharm, Post grad Dip. Biomedical Research Methodology</td>\n </tr>\n <tr height=\"34\">\n <td height=\"34\" style=\"height:34px;width:172px;\">\n Ezekiel Muinde</td>\n <td style=\"width:128px;\">\n Pharmaceutical Technologist</td>\n <td style=\"width:101px;\">\n KEMRI</td>\n <td colspan=\"4\" style=\"width:616px;\">\n Dip. Pharmacy</td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Simon Maina</td>\n <td style=\"width:128px;\">\n Pharmacist</td>\n <td style=\"width:101px;\">\n KEMRI</td>\n <td colspan=\"4\" style=\"width:616px;\">\n Higher Dip. Psychological Counselling, Cert. Pharmauceutical technology</td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Stephen Chege</td>\n <td style=\"width:128px;\">\n Procurement Officer</td>\n <td style=\"width:101px;\">\n KEMRI</td>\n <td colspan=\"4\" style=\"width:616px;\">\n Dip. Purchasing and Supplies,  Accounts Clerk</td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Fred Orina</td>\n <td style=\"width:128px;\">\n Lab QC</td>\n <td style=\"width:101px;\">\n KEMRI</td>\n <td colspan=\"4\" style=\"width:616px;\">\n Msc. Mycobacteriology, BSc. Medical Microbiology</td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Martha Wambui Njoroge</td>\n <td style=\"width:128px;\">\n Lab Manager</td>\n <td style=\"width:101px;\">\n KEMRI</td>\n <td colspan=\"4\" style=\"width:616px;\">\n HDip. Medical Laboratory Technology, Dip. Medical Laoratory Technology</td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Glennah Kerubo</td>\n <td style=\"width:128px;\">\n TB Lab Staff</td>\n <td style=\"width:101px;\">\n KEMRI</td>\n <td colspan=\"4\" style=\"width:616px;\">\n MSc. Medical Microbiology, BSc Medical Microbiology</td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Dorcus Marionya</td>\n <td style=\"width:128px;\">\n TB Lab Staff</td>\n <td style=\"width:101px;\">\n KEMRI</td>\n <td colspan=\"4\" style=\"width:616px;\">\n MSc. Medical Mycobacteriology, BSc..Biomedical Lab Sciences and Tech., Dip. Community Health Devt.</td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Dorcas  Wachira</td>\n <td style=\"width:128px;\">\n CD4 Lab</td>\n <td style=\"width:101px;\">\n KEMRI</td>\n <td colspan=\"4\" style=\"width:616px;\">\n MSc. Immunology, BSc. Zoology</td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Kenneth Korir</td>\n <td style=\"width:128px;\">\n Driver</td>\n <td style=\"width:101px;\">\n KEMRI</td>\n <td colspan=\"4\" style=\"width:616px;\">\n Driver Grade III</td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Wambui Salome</td>\n <td style=\"width:128px;\">\n Driver</td>\n <td style=\"width:101px;\">\n KEMRI</td>\n <td colspan=\"4\" style=\"width:616px;\">\n Driver Grade III</td>\n </tr>\n <tr height=\"34\">\n <td height=\"34\" style=\"height:34px;width:172px;\">\n Elizabeth Kendi</td>\n <td style=\"width:128px;\">\n Administative support</td>\n <td style=\"width:101px;\">\n KEMRI</td>\n <td colspan=\"4\" style=\"width:616px;\">\n Secretarial</td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Josephine Okwirry</td>\n <td style=\"width:128px;\">\n Accountant</td>\n <td style=\"width:101px;\">\n KEMRI</td>\n <td colspan=\"4\" style=\"width:616px;\">\n CPA I,II,III,IV</td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;width:172px;\">\n Ephantus Kinyua</td>\n <td style=\"width:128px;\">\n Accountant</td>\n <td style=\"width:101px;\">\n KEMRI</td>\n <td colspan=\"4\" style=\"width:616px;\">\n Bcom. Accounts</td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_explanation<p>\n The sponsor, Global Alliance for TB Drug Development, has its head quaters in <span style=\"font-family: Helvetica, Arial, Tahoma, sans-serif; line-height: 12px;\">New York and has offices in Brussels, Belgium and Pretoria, South Africa, though their work is performed globally through their extensive network of partners .   South Africa was one of the participating sites and is one of the representatives of the sponsor. </span></p>\n
      • other_details_regulatory_notapproved<p>\n Not applicable</p>\n
      • other_details_regulatory_approved<p>\n Not applicable</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration5 yrs
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorthe standard TB treatment
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKibera D.O Health Centre
      • single_site_physical_addressD.O Office Kibera
      • single_site_contact_personMatron Incharge Mrs. Omune Joyce
      • single_site_telephone+254 721 575427
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states9
      • number_of_sites
      • multi_country_listKenya, South Africa, Zambia, Tanzania, India, China, Thailand, Malaysia, Mexico
      • data_monitoring_committeeYes
      • total_enrolment_per_site136
      • total_participants_worldwide1931
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameStephen
      • investigator1_middle_nameHenry
      • investigator1_family_nameGillespie
      • investigator1_qualificationMD DSc FRCP FRCPath
      • investigator1_professional_addressCentre for Clinical Microbiology, University College Medical School, London, UK.
      • investigator1_telephone+44(0)2077940500 ext 33539
      • investigator1_emails.gillespie@medsch.ucl.ac.uk
      • organisations_transferred_Yes
      • number_participants150
      • notification<p>\n I kindly request for annual approval for the REMoxTB project. I have re submitted the neccesary documents for your review. Looking forwards to a favourable feedback.</p>\n<p>\n Kind Regards</p>\n<p>\n Miheso B, Barbara</p>\n<p>\n Study Coodinator REMoxTB Clinical Trial</p>\n<p>\n  </p>\n
      • approval_date01-07-2013
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted26-07-2013
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<div class=\"views-field views-field-title\" style=\"color: rgb(120, 112, 125); font-family: Roboto, sans-serif; font-size: 16px; line-height: 24px;\">\n <h2 class=\"field-content trial\" style=\"font-size: 1.2em; margin: 0px 0px 0.75em; font-family: Montserrat, sans-serif; font-weight: 400; line-height: 1.3em;\">\n <span style=\"color:#000000;\">REMoxTB</span></h2>\n</div>\n<div class=\"views-field views-field-field-partners classification\" style=\"color: rgb(120, 112, 125); font-family: Roboto, sans-serif; font-size: 16px; line-height: 24px;\">\n <span style=\"color:#000000;\"><span class=\"views-label views-label-field-partners\">Partners: </span><span class=\"field-content\">Medical Research Council at University College London, University College London</span></span></div>\n<div class=\"views-field views-field-field-blurb\" style=\"color: rgb(120, 112, 125); font-family: Roboto, sans-serif; font-size: 16px; line-height: 24px;\">\n <p class=\"field-content blurb-trial\" style=\"margin: 0px 0px 1.5em; line-height: 1.7em;\">\n <span style=\"color:#000000;\">REMoxTB was a global Phase 3 clinical trial conducted at nearly 50 sites. The trial tested whether substituting moxifloxacin for a single drug in the standard TB therapy could reduce treatment of drug-sensitive disease from six months to four.</span></p>\n</div>\n<div class=\"views-field views-field-field-background\" style=\"color: rgb(120, 112, 125); font-family: Roboto, sans-serif; font-size: 16px; line-height: 24px;\">\n <span style=\"color:#000000;\"><span class=\"views-label views-label-field-background block-label\">Background:</span></span>\n <div class=\"field-content\">\n <p style=\"margin: 0px 0px 1.5em; line-height: 1.7em;\">\n <span style=\"color:#000000;\"><span style=\"font-weight: 700;\">Overview</span></span></p>\n <p style=\"margin: 0px 0px 1.5em; line-height: 1.7em;\">\n <span style=\"color:#000000;\">REMoxTB was a global Phase 3 clinical trial conducted at 50 sites across 9 countries. The trial’s aim was to determine whether a </span><a href=\"http://www.tballiance.org/portfolio/compound/moxifloxacin#\" style=\"text-decoration: none; color: rgb(52, 175, 231);\"><span style=\"color:#000000;\">moxifloxacin</span></a><span style=\"color:#000000;\">-containing TB treatment regimen could reduce the time needed to treat drug-sensitive TB patients from 6 months or longer to 4 months. REMox TB was completed in 2013, after enrolling and monitoring 1931 patients across 50 trial sites around the world. </span></p>\n <p style=\"margin: 0px 0px 1.5em; line-height: 1.7em;\">\n <span style=\"color:#000000;\"><span style=\"font-weight: 700;\">About the New Treatments</span></span></p>\n <p style=\"margin: 0px 0px 1.5em; line-height: 1.7em;\">\n <span style=\"color:#000000;\">The REMoxTB trial tested 2 new treatment regimens for drug-sensitive TB. Both of these regimens substitute moxifloxacin, an already approved antibiotic for other indications, for an individual drug in the current first-line TB treatment regimen (</span><a href=\"http://www.tballiance.org/portfolio/compound/isoniazid\" style=\"text-decoration: none; color: rgb(52, 175, 231);\"><span style=\"color:#000000;\">isoniazid</span></a><span style=\"color:#000000;\"> + </span><a href=\"http://www.tballiance.org/portfolio/compound/rifampin\" style=\"text-decoration: none; color: rgb(52, 175, 231);\"><span style=\"color:#000000;\">rifampin</span></a><span style=\"color:#000000;\"> + </span><a href=\"http://www.tballiance.org/portfolio/compound/pyrazinamide\" style=\"text-decoration: none; color: rgb(52, 175, 231);\"><span style=\"color:#000000;\">pyrazinamide</span></a><span style=\"color:#000000;\"> +</span><a href=\"http://www.tballiance.org/portfolio/compound/ethambutol\" style=\"text-decoration: none; color: rgb(52, 175, 231);\"><span style=\"color:#000000;\"> ethambutol</span></a><span style=\"color:#000000;\"> [HRZE]). In separate arms of the trial, REMoxTB evaluated moxifloxacin in place of isoniazid and ethambutol. </span></p>\n <p style=\"margin: 0px 0px 1.5em; line-height: 1.7em;\">\n <span style=\"color:#000000;\"><span style=\"font-weight: 700;\">About the REMox TB trial</span></span></p>\n <p style=\"margin: 0px 0px 1.5em; line-height: 1.7em;\">\n <span style=\"color:#000000;\">REMoxTB was conducted at 50 sites around the world by TB Alliance, Bayer Healthcare AG, University College London, and the Medical Research Council. It was the first Phase 3 TB drug trial conducted and completed in accordance with the most stringent modern regulatory standards, and it helped pave the way for subsequent clinical research and influence regulatory standards in the field. The trial was also conducted with significant involvement from local communities through </span><a href=\"http://www.tballiance.org/access/engaging-communities.php\" style=\"text-decoration: none; color: rgb(52, 175, 231);\"><span style=\"color:#000000;\">community advisory structures</span></a><span style=\"color:#000000;\"> promoted by TB Alliance to give communities a voice in the research process.</span></p>\n <p style=\"margin: 0px 0px 1.5em; line-height: 1.7em;\">\n <span style=\"color:#000000;\"><span style=\"font-weight: 700;\">Results</span></span></p>\n <p style=\"margin: 0px 0px 1.5em; line-height: 1.7em;\">\n <span style=\"color:#000000;\">As reported in the </span><a href=\"http://www.nejm.org/doi/full/10.1056/NEJMoa1407426?query=featured_home#t=articleTop\" style=\"text-decoration: none; color: rgb(52, 175, 231);\"><span style=\"color:#000000;\"><em>New England Journal of Medicine</em></span></a><span style=\"color:#000000;\">, the REMoxTB Phase 3 trial showed that the two regimens tested in the trial were found to be safe, but did not shorten the time it takes to treat drug-sensitive TB from six to four months. The study showed that the experimental regimens, which substituted moxifloxacin for either isoniazid or ethambutol in the first-line treatment for drug-sensitive TB, were more bacteridical in the earlier stages of treatment and converted patients to negative culture sooner than the standard of care, however patients in the experimental arms were more likely to relapse in the year following therapy. Thus, there was insufficient effect to permit regimen shortening by two months.</span></p>\n <p style=\"margin: 0px 0px 1.5em; line-height: 1.7em;\">\n <span style=\"color:#000000;\">The trial also yielded other valuable findings. Importantly, REMoxTB was the first regulatory study to confirm the safety of daily moxifloxacin over four months of therapy. Its safety, combined with its activity against TB, supports the continued clinical testing of moxifloxacin as a component of other, novel regimens, such as </span><a href=\"http://www.tballiance.org/portfolio/regimen/pamz\" style=\"text-decoration: none; color: rgb(52, 175, 231);\"><span style=\"color:#000000;\">PaMZ</span></a><span style=\"color:#000000;\">.</span></p>\n <p style=\"margin: 0px 0px 1.5em; line-height: 1.7em;\">\n <span style=\"color:#000000;\">Also of interest, it had previously been thought that there were regional differences in patients' response to treatment across the world. The trial demonstrated no evidence that populations respond differently to treatment.</span></p>\n </div>\n</div>\n<p>\n  </p>\n
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2018-10-15 16:16:03
      • created2013-07-17 09:12:01
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id111
        • application_id171
        • given_nameEvans
        • middle_nameInyangala
        • family_nameAmukoye
        • qualificationMbChb (MD), M.Med , Clinical fellow Pulmunolgy
        • professional_addressCentre for Respiratory Diseases Research, Kenya Medical Research Institute , Kenyatta Hospital Compound, Next to Government Chemist, Off Ngong Road , P.O. Box 47855 – 00100, Nairobi, Kenya
        • telephone(254) (020) 2724264/5
        • emailamukoye@gmail.com
        • created2013-07-18 15:34:51
        • modified2013-07-26 04:05:30
    • SiteDetail(array)
      • 0(array)
        • id140
        • application_id171
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2013-07-18 15:34:51
        • modified2013-07-26 04:05:30
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id87
        • application_id171
        • sponsorGlobal Alliance for TB Drug Development, New York, USA
        • sponsor_type(null)
        • contact_personAlmarie Uys
        • addressJohannesburg
        • telephone_number+27128440953
        • fax_number+27128440959
        • cell_number+27836016136
        • email_addressalmarie.uys@tballiance.org
        • created2013-07-18 15:34:51
        • modified2013-07-26 04:05:30
  • 1(array)
    • Application(array)
      • id167
      • user_id81
      • trial_status_id8
      • abstract_of_study<p>\n A 2x2x2 open-label factorial multi-centre trial, conducted in 9 centres in 4 countries (Kenya, Malawi, Uganda, Zimbabwe) involving 1800 HIV-infected patients (approximately 300 in Kilifi) including adults, adolescents and children aged 5 years or older with low CD4 counts, about to initiate combination antiretroviral therapy (ART). The trial will examine three interventions which aim to reduce early mortality following ART initiation in previously untreated patients presenting late with very low CD4 counts:</p>\n<p>\n  </p>\n<p style=\"margin-left:16.15pt;\">\n (i)  increasing the potency of ART with a 12 week induction period using 4 antiretroviral drugs from 3 classes</p>\n<p style=\"margin-left:16.15pt;\">\n (ii) augmented prophylaxis against opportunistic/bacterial infections and helminths for 12 weeks</p>\n<p style=\"margin-left:16.15pt;\">\n (iii) macronutrient intervention using ready-to-use supplementary food for 12 weeks.</p>\n<p>\n  </p>\n<p>\n Each intervention will be compared with standard of care, which is normally to initiate ART with 3 drugs from 2 classes, together with cotrimoxazole prophylaxis, with macronutrient intervention only for those with very low BMI or  weight-for-height.</p>\n<p>\n  </p>\n<p>\n Participants will be enrolled at the comprehensive care and research  clinic (CCRC) in Kilifi, at presentation or referral from the wards, and will be randomised over a period of 1.5-2 years. Each intervention will be administered in addition to standard of care for 12 weeks. All participants will be followed for 48 weeks in the trial. The start of the trial will be mid-2012 and its overall duration will be 3 years.</p>\n<p>\n  </p>\n<p>\n The primary outcome is all-cause mortality over the first 24 weeks after starting ART. Secondary outcomes include 48 week mortality (all-cause);  Safety (serious adverse events, grade 4 adverse events;  adverse events leading to modification of ART or other study drugs) Endpoints relating to the specific mechanisms of action of each intervention ( anti-HIV: CD4 cell counts;  anti-infection: incidence of TB, cryptococcal and candida disease, severe bacterial infections; nutritional: BMI, weight and body fat assessed by bioimpedance analysis (BIA), height (in children), grip strength);  Hospital inpatient episodes and adherence to ART and acceptability of each strategy.</p>\n<p>\n  </p>\n<p>\n To assess these end point these will neccessitate:</p>\n<p>\n  </p>\n<ul>\n <li>\n data colllection to evaluate economics and cost-effectiveness</li>\n <li>\n Sample collection to enable molecular diagnostics and phenotypic and genotypic analysis of pathogens isolated; HIV RNA viral load and resistance;</li>\n <li>\n Investigation of the immunological effects of the interventions in relation to control of HIV replication, systemic and gut inflammation, microbial translocation and immune reconstitution inflammatory syndrome, specifically</li>\n <li style=\"margin-left: 0.75in;\">\n Cellular immune activation (detailed immunophenotyping and markers of cellular turnover and senescence, particularly CD3+CD8+CD38+HLA-DR+, CD3+CD8-CD38+HLA-DR+)</li>\n <li style=\"margin-left: 0.75in;\">\n Functional whole blood ex-vivo responses to pathogen challenges, including LPS and viral and fungal antigens</li>\n <li style=\"margin-left: 0.75in;\">\n Markers of systemic inflammation (CRP, cytokines, chemokines, D-dimer)</li>\n <li style=\"margin-left: 0.75in;\">\n Markers of enteric inflammation (fecal calprotectin, a1-antitrypsin, neopterin)</li>\n <li style=\"margin-left: 0.75in;\">\n Markers of microbial translocation (soluble CD14, lipopolysaccharide (LPS), anti-LPS antibodies, pathogen detection by 16s PCR)</li>\n</ul>\n<p>\n  </p>\n<p>\n The trial will involve 8 – 10 mls of blood taken at standard clinic visits to be divided as follows: haematology/lymphocyte subsets/immunophenotyping (1.5 – 2mls); Biochemistry (1.5 mls) and the remaining 6.5 – 7mls for plasma storage. Stools sample will be stored at each visit. Besides investigation for clinical care (e.g. microbial cultures) additional 8-10 mls blood will be drawn and plasma (5-7mls) will be stored during acute admission.</p>\n<p>\n  </p>\n
      • study_title<p>\n <strong>Reduction of EArly mortaLITY in HIV-infected adults and children starting antiretroviral therapy</strong></p>\n
      • laymans_summary<div>\n <strong>What is the problem?</strong></div>\n<div>\n Many people affected by HIV/AIDS are still starting antiretroviral (ARV) treatment later than is recommended. This is often because they did not know they had HIV until they became sick. It means that their immune system is already very compromised, and they are at risk of death from infections. Unfortunately, amongst those with a severely compromised immune system, the risk of a variety of infections such as TB, fungi or those caused by bacteria remains high for several months even after starting ARVs. It has also been observed that those with poor nutritional status have an increased risk of death after starting ARVs compared to people with a better nutritional status.</div>\n<div>\n  </div>\n<div>\n <strong>What questions are we trying to answer?</strong></div>\n<div>\n This study is a trial that will assess three different potential means of preventing death in people with HIV and a severely compromised immune system who are starting ARVs, The three interventions are: four ARV drugs instead of three; extra drugs to prevent TB, fungal and bacterial infections; and enhanced nutritional support.</div>\n<div>\n  </div>\n<div>\n <strong>Where is the study taking place, how many people does it involve and how are they selected?</strong></div>\n<div>\n The study is taking place at 9 clinics in 4 countries: Kenya, Uganda, Zimbabwe and Malawi. In Kilifi, we aim to recruit up to 300 people. They will be selected if they are adults or children who are 5 years old or more, eligible to start ART and have very low CD4 counts (less than 100) indicating a severely compromised immune system. Women who are pregnant or those who have previously received ARVs will not be included.</div>\n<div>\n  </div>\n<div>\n <strong>What does the study involve for those who are in it?</strong></div>\n<div>\n Initially, information will be given about the study and consent sought for a screening blood test to confirm that the person is eligible. Then, detailed information about the study will be given, and consent to participate sought. The person will randomly receive 0,1,2, or 3 of the interventions in addition to standard care according to national guidelines. Participants will be reviewed in the clinic monthly. Blood tests will be taken at baseline, 4, 12, 24, 36 and 48 weeks to monitor progress and check for any adverse effects, a total of 8 to 10ml (2 teaspoons) each time. The study activities will finish after 48 weeks when the person will return to normal standard care.</div>\n<div>\n  </div>\n<div>\n <strong>What are the benefits and risks/costs of the study for those involved?</strong></div>\n<div>\n There are no direct benefits to taking part. However, participants will receive a high standard of care including supportive treatment and investigation. The cost of fares to attend follow up visits will be met by the study team. The risks are minor discomfort at blood sampling, the potential for toxicity from the additional drugs, and the potential for compliance problems with an additional pill burden.</div>\n<div>\n  </div>\n<div>\n <strong>How will the study benefit society?</strong></div>\n<div>\n <div>\n The results of this trial may lead to improved protocols for treating people with HIV that could save lives in the future.</div>\n <div>\n  </div>\n <div>\n <strong>When does the study start and finish?</strong></div>\n <div>\n The study is expected to begin in the third quarter of 2012 and continue for 3 years. Each participant will be involved for 48 weeks</div>\n</div>\n<p>\n  </p>\n
      • short_titleREALITY Trial
      • protocol_noECCT/12/09/03
      • version_no2.3
      • date_of_protocol11-10-2012
      • study_drug1. Raltegravir (Integrase Inhibitor) 2. FDC- (Isoniazid/pyridoxine/cotrimoxazole), fluconazole, azithromycin, albendazole 3. Ready-to-use Supplementary Food (RUSF)
      • disease_conditionHIV/AIDS
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameIsentress, Fixed Dose Combination- (Isoniazid/pyridoxine/cotrimoxazole), fluconazole, azithromycin, albendazole, Ready-to-use Supplementary Food (RUSF)
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressctfuser@kemri-wellcome.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries1
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDr Clara Agutu, CAgutu@kemri-wellcome.org
      • declaration_date127-01-2014
      • declaration_principal_investigatorDr Anthony Etyang, AEtyang@kemri-wellcome.org
      • declaration_date227-01-2014
      • placebo_presentNo
      • study_objectives<ol style=\"list-style-type:lower-alpha;\">\n <li>\n General Objectives</li>\n</ol>\n<p style=\"margin-left:72.0pt;\">\n  </p>\n<p>\n To identify effective, safe and acceptable interventions to reduce early mortality (all-cause) in HIV-infected individuals initiating ART at low CD 4 counts.</p>\n<p>\n  </p>\n<ol style=\"list-style-type:lower-alpha;\">\n <li value=\"2\">\n Specific Objectives</li>\n</ol>\n<p>\n  </p>\n<ul>\n <li>\n To determine the efficacy of augmented ART, antimicrobial prophylaxis and additional nutritional support in preventing early mortality in individuals starting ART at very low CD4 counts.</li>\n <li>\n identifying the most cost-effective interventions to reduce early all-cause mortality, and assessing their budget impact</li>\n <li>\n identifying the mechanism of action of the most effective interventions through focussed investigations of viral load and resistance, molecular diagnostics, measures of immune activation, immune responses to pathogens, microbial translocation and enteropathy, and body composition (see footnote of Table 1 which states whether the assays will be conducted locally or in other laboratories)</li>\n <li>\n identifying the most effective ways to promote acceptance of additional strategies in the community, particularly with regard to potential stigmatising impact of increased pill burden</li>\n</ul>\n
      • principal_inclusion_criteria<p style=\"margin-left:.5in;\">\n 1)      Aged 5 years or older</p>\n<p style=\"margin-left:.5in;\">\n 2)      Documented HIV infection by HIV ELISA or HIV rapid test</p>\n<p style=\"margin-left:.5in;\">\n 3)      Naive to ART</p>\n<p style=\"margin-left:.5in;\">\n 4)      CD4 T-cell count <100 cells/mm³</p>\n<p style=\"margin-left:.5in;\">\n 5)      Results of screening haematology and biochemistry tests available and no contraindications to planned ART according to national guidelines</p>\n<p style=\"margin-left:.5in;\">\n 6)      Patient/carer provide informed consent (and children <18 years assent, as appropriate according to their age and knowledge of HIV status)<br />\n  </p>\n
      • principal_exclusion_criteria<p style=\"margin-left:.5in;\">\n 1)      Contraindications to any proposed antiretroviral drugs (including integrase inhibitors), isoniazid, fluconazole, albendazole or azithromycin     </p>\n<p style=\"margin-left:.5in;\">\n 2)      Pregnant or breastfeeding or intending to become pregnant during the first 12 weeks of the study</p>\n<p style=\"margin-left:.5in;\">\n 3)      Ever<strong> known</strong> to have previously received <u>single-dose</u> nevirapine for prevention of mother-to-child transmission (mother or child).          </p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p>\n Patients with acute illnesses but whose clinicians judge that – for their own health – it is important for them to initiate ART are eligible for REALITY, because it is precisely these patients who are at highest risk of early mortality on ART. These patients are eligible regardless of what other medications are being used to treat their underlying illness, provided there are no contraindications to the study drugs (see above). In particular, patients receiving isoniazid (alone or together with other anti-tuberculous drugs for the treatment of active tuberculosis), fluconazole or azithromycin for treatment of acute illnesses <u>are eligible</u> for randomisation in the trial – they will continue pre-existing medications for treatment, and start any other prophylaxis drugs as randomised. Patients already receiving anti-tuberculous therapy who are randomized to receive isoniazid in REALITY will continue isoniazid once their TB treatment regimen finishes (if this occurs within 12 weeks of randomization). Patients receiving isoniazid preventative therapy as part of TB contact tracing are also eligible: they will continue pre-existing isoniazid for prophylaxis, and start any other prophylaxis drugs as randomised. Patients requiring therapeutic feeding for severe malnutrition will receive this, and start any other prophylaxis drugs as randomised. This reflects the fact that REALITY is a pragmatic strategy trial and that patients presenting sick receiving concomitant medications are the target population to which REALITY results must be generalisable.</p>\n<p>\n <br />\n As women and older children will be presenting acutely with CD4<100 cells/mm3 it is extremely unlikely that any will have taken <u>single dose</u> nevirapine for the the prevention of mother-to-child transmission. However, as NNRTI-based regimens could have suboptimal efficacy, any such women and children who know they have received single-dose nevirapine will not be eligible. Any women or child who does not know whether or not they have received <u>single-dose</u> nevirapine is eligible. On the screening questionaire degree and frequency of alcohol consumption will be assertained using the CAGE criteria. Where the clinician is concerned about excess consumption- a positive response to ≥ 2 of the 4  criteria (and increase to likelihood of poor trial compliance)- the patient may not be enrolled in the trial. However, alcohol consumption is not an exclusion critieria.</p>\n
      • primary_end_points<p>\n The primary outcome is all-cause mortality over the first 24 weeks after starting ART. Secondary outcomes include 48 week mortality (all-cause);  Safety (serious adverse events, grade 4 adverse events;  adverse events leading to modification of ART or other study drugs) Endpoints relating to the specific mechanisms of action of each intervention ( anti-HIV: CD4 cell counts;  anti-infection: incidence of TB, cryptococcal and candida disease, severe bacterial infections; nutritional: BMI, weight and body fat assessed by bioimpedance analysis (BIA), height (in children), grip strength);  Hospital inpatient episodes and adherence to ART and acceptability of each strategy.</p>\n<p>\n Other outcomes to be assessed in a subset of the population:</p>\n<ul>\n <li>\n HIV RNA viral load and resistance;</li>\n <li>\n Investigation of the immunological effects of the interventions in relation to control of HIV replication, systemic and gut inflammation, microbial translocation and immune reconstitution inflammatory syndrome, specifically</li>\n <li style=\"margin-left: 0.75in;\">\n Cellular immune activation (detailed immunophenotyping and markers of cellular turnover and senescence, particularly CD3+CD8+CD38+HLA-DR+, CD3+CD8-CD38+HLA-DR+)</li>\n <li style=\"margin-left: 0.75in;\">\n Functional whole blood ex-vivo responses to pathogen challenges, including LPS and viral and fungal antigens</li>\n <li style=\"margin-left: 0.75in;\">\n Markers of systemic inflammation (CRP, cytokines, chemokines, D-dimer)</li>\n <li style=\"margin-left: 0.75in;\">\n Markers of enteric inflammation (fecal calprotectin, a1-antitrypsin, neopterin)</li>\n <li style=\"margin-left: 0.75in;\">\n Markers of microbial translocation (soluble CD14, lipopolysaccharide (LPS), anti-LPS antibodies, pathogen detection by 16s PCR)</li>\n</ul>\n<p>\n  </p>\n
      • scope_diagnosis1
      • scope_prophylaxis1
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <strong>KILIFI SITE- KEMRI Wellcome Trust Research Programme</strong></p>\n<div>\n <strong>Principal Investigator</strong></div>\n<div>\n  </div>\n<div>\n Dr Anthony Etyang</div>\n<div>\n MBChB, MMED</div>\n<div>\n  </div>\n<div>\n <strong>Co-Investigators</strong></div>\n<div>\n  </div>\n<div>\n <div>\n Dr Jay Berkley</div>\n <div>\n MBBS, MTropMed MD MRCP FRCPCH</div>\n <div>\n  </div>\n <div>\n Prof Kath Maitland \n <div>\n MBBS, MRCP Paediatrics, PhD</div>\n <div>\n  </div>\n <div>\n Dr Patricia Njuguna\n <div>\n MBChB, MMED</div>\n <div>\n  </div>\n <div>\n Mr Amin Hassan\n <div>\n BSN, MSc</div>\n <div>\n  </div>\n <div>\n <div>\n Shalton Mwaringa, </div>\n <div>\n Diploma in Clinical Medicine and Surgery, Higher National Diploma in Paediatrics</div>\n </div>\n <div>\n  </div>\n </div>\n </div>\n </div>\n <div>\n <strong>Study Co-ordinator</strong></div>\n <div>\n  </div>\n <div>\n Dr Clara Agutu</div>\n <div>\n MBChB, MPH</div>\n <div>\n  </div>\n</div>\n<div>\n  </div>\n
      • other_details_explanation<p>\n HIV-infected adults and children in resource-limited countries have a clear excess risk of death and disease progression after starting antiretroviral therapty (ART) compared to those in resource-rich countries. The proposed locations have large patient populations starting ART, covering four countries in East/ Southern Africa with substantial HIV epidemics. All centres have experience of international research, and this trial will provide support to maintain and further develop critical mass in locally-led public health research. Further, all four proposed centres have joint family clinics where adults and children are seen together at the same locations, increasingly common with ART provisions across Africa, given the shortage of paediatric expertise. </p>\n
      • other_details_regulatory_notapproved<p>\n None- (Kilifi, Kenya Site)</p>\n
      • other_details_regulatory_approved<p>\n University College London Research Ethics Committee (approval of multi-centre protocol)- 17January 2012</p>\n<p>\n KEMRI Ethics Review Committee </p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration3 years (1.5-2years of randomisation, and a year of follow-up)
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorRaltegravir (Integrase In
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states9 centres in 4 countries
      • number_of_sites2
      • multi_country_listKenya, Malawi, Uganda, Zimbabwe
      • data_monitoring_committeeYes
      • total_enrolment_per_siteKilifi (245)\nEldoret (245)\nTotal 490
      • total_participants_worldwide1800
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationYes
      • subjects_incapable_consentYes
      • subjects_specifyChildren between 5 and 7 years are not considered to be able to give assent for participating in any trial. However, consent will be sought from parents for their participation.
      • subjects_othersYes
      • subjects_others_specifyPatients with acute illnesses but whose clinicians judge that – for their own health – it is important for them to initiate ART are eligible for REALITY, because it is precisely these patients who are at highest risk of early mortality on ART. These patients are eligible regardless of what other medications are being used to treat their underlying illness, provided there are no contraindications to the study drugs (see above). In particular, patients receiving isoniazid (alone or together with other anti-tuberculous drugs for the treatment of active tuberculosis), fluconazole or azithromycin for treatment of acute illnesses are eligible for randomisation in the trial – they will continue pre-existing medications for treatment, and start any other prophylaxis drugs as randomised. Patients already receiving anti-tuberculous therapy who are randomized to receive isoniazid in REALITY will continue isoniazid once their TB treatment regimen finishes (if this occurs within 12 weeks of randomization). Patients receiving isoniazid preventative therapy as part of TB contact tracing are also eligible: they will continue pre-existing isoniazid for prophylaxis, and start any other prophylaxis drugs as randomised. Patients requiring therapeutic feeding for severe malnutrition will receive this, and start any other prophylaxis drugs as randomised. This reflects the fact that REALITY is a pragmatic strategy trial and that patients presenting sick receiving concomitant medications are the target population to which REALITY results must be generalisable.\n\nAs women and older children will be presenting acutely with CD4<100 cells/mm3 it is extremely unlikely that any will have taken single dose nevirapine for the the prevention of mother-to-child transmission. However, as NNRTI-based regimens could have suboptimal efficacy, any such women and children who know they have received single-dose nevirapine will not be eligible. Any women or child who does not know whether or not they have received single-dose nevirapine is eligible. On the screening questionaire degree and frequency of alcohol consumption will be assertained using the CAGE criteria. Where the clinician is concerned about excess consumption- a positive response to ≥ 2 of the 4 criteria (and increase to likelihood of poor trial compliance)- the patient may not be enrolled in the trial. However, alcohol consumption is not an exclusion critieria. \n
      • investigator1_given_nameDR ANTHONY
      • investigator1_middle_nameOLIWA
      • investigator1_family_nameETYANG
      • investigator1_qualificationMBChB, MMED
      • investigator1_professional_addressKEMRI Wellcome Trust Research Programme, P.O.Box 230, 80108, Kilifi-Kenya
      • investigator1_telephone+254-722-417507
      • investigator1_emailAEtyang@kemri-wellcome.org
      • organisations_transferred_No
      • number_participants490
      • notification
      • approval_date05-07-2012
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted30-09-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2021-09-30 18:49:21
      • created2013-07-08 09:09:16
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id108
        • application_id167
        • given_nameDR ANTHONY
        • middle_nameOLIWA
        • family_nameETYANG
        • qualificationMBChB, MMED (Internal Medicine)
        • professional_addressKEMRI Wellcome Trust Research Programme, P.O.Box 230, 80108, Kilifi-Kenya
        • telephone+245-722-417507
        • emailAEtyang@kemri-wellcome.org
        • created2013-07-08 10:11:29
        • modified2021-09-30 18:49:21
    • SiteDetail(array)
      • 0(array)
        • id134
        • application_id167
        • county_id3
        • site_nameKEMRI Wellcome Trust Research Programme
        • physical_addressKilifi-Kenya
        • contact_detailsP.O.Box 230, 80108, Kilifi-Kenya
        • contact_personDr Anthony Etyang
        • site_capacity(null)
        • misc(null)
        • created2013-07-08 10:11:29
        • modified2021-09-30 18:49:21
        • County(array)
          • id3
          • county_nameKilifi
          • created2012-05-31 16:15:49
          • modified2012-05-31 16:15:49
      • 1(array)
        • id135
        • application_id167
        • county_id27
        • site_nameMoi University School of Medicine, Academic Model for the Prevention and Treatment of HIV/AIDS (AMPATH) Centre at Moi Teaching Referral Hospital (MTRH)
        • physical_addressEldoret, Kenya
        • contact_detailsP.O. Box 4606, 30100 Eldoret, Kenya
        • contact_personDr Abraham M. Siika
        • site_capacity(null)
        • misc(null)
        • created2013-07-08 11:08:58
        • modified2021-09-30 18:49:21
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
    • Sponsor(array)
      • 0(array)
        • id85
        • application_id167
        • sponsorMedical Research Council, UK
        • sponsor_typeOthers
        • contact_personDr Margaret Thomason
        • addressMRC Clinical Trials Unit (CTU) Infections Theme Aviation House, 125 Kingsway, London WC2B 6NH, UK
        • telephone_number+44 (0) 20 7670 4700
        • fax_number+44 (0) 20 7670 4816
        • cell_number+44 (0) 207 670 4615
        • email_addressmjth@ctu.mrc.ac.uk
        • created2013-07-08 10:11:29
        • modified2021-09-30 18:49:21
  • 2(array)
    • Application(array)
      • id158
      • user_id81
      • trial_status_id8
      • abstract_of_study<p>\n Malaria transmission has been on the decline in some parts of Africa in association with scaling up of malaria control measures such as bed-nets and anti-malarials. However, transmission still persists and it appears that additional control measures including vaccination are required. The leading malaria vaccine candidate in development is RTS,S which has efficacy against clinical malaria measured at 30-50% in the field. This partial protection might be enhanced by combination with other components. The other vaccination approach that has produced repeatable efficacy in humans is the use of viral vectors to induce T cell responses.</p>\n<p>\n The field trials required to test malaria vaccines require large sample sizes and are laborious and time-consuming. Previous studies have relied on blood films to diagnose infection, but Polymerase Chain Reaction (PCR) based technology is considerably more sensitive, and therefore may reduce the sample size and period of monitoring required.   The first such trial was conducted in the Gambia. Adult subjects were recruited, treated with curative anti-malarials, and then followed up by daily finger-prick blood testing to identify the first episode of PCR-measured parasitaemia. Subjects given anti-malarial vaccine were compared with control subjects, and were less frequently parasitaemic as measured by PCR.</p>\n<p>\n We have recently repeated a similar trial design in Kenya (SSC no.2116) PPB/ECCT/11/12/02. Although the statistical analysis has remained blinded to vaccine allocation since data cleaning is incomplete, our examination of blinded data without reference to vaccination status gives cause for concern for two reasons; a) there are a substantial number of positives remaining after anti-malarials (i.e. atovaquone/proguanil and artesunate) were given (17%, compared with 60% prior to giving anti-malarials), and there are very few positive PCR results after drug clearance, and the majority are at low levels.</p>\n<p>\n We therefore propose a phase IIb trial design study that aims at determining the best anti-malarial drug regimen that will be used in future malaria vaccine trials to clear parasites before carrying out tests to check if a malaria vaccine is preventing one from acquiring new infections. We will therefore not administer any vaccine in this trial, since we are only interested in the correct choice of drug at this stage. 90 healthy adults (both male and female) will be recruited for this purpose in Kilifi district.</p>\n
      • study_title<p align=\"JUSTIFY\" style=\"margin-bottom: 0in; line-height: 100%\">\n <font face=\"Times New Roman, serif\"><font size=\"3\">Comparing drug-regimens for clearing parasites in Phase IIb trial designs prior to PCR monitoring for </font></font><font face=\"Times New Roman, serif\"><font size=\"3\"><i>Plasmodium falciparum </i></font></font><font face=\"Times New Roman, serif\"><font size=\"3\">infection.</font></font></p>\n
      • laymans_summary<p>\n LAY SUMMARY<br />\n Formal title: Comparing drug-regimens for clearing parasites in Phase IIb trial designs prior to PCR monitoring for Plasmodium falciparum infection<br />\n <br />\n Lay Title: A study to compare how three different anti-malarial drug regimens can clear parasites from the blood.<br />\n <br />\n What is the background?<br />\n Malaria is a leading cause of illness and deaths in Africa. A malaria vaccine is therefore still a high priority for malaria control in Kenya as well as other African countries.<br />\n We want vaccines to protect children, but for reasons of safety prefer to test them in adults first.  Adults in Kenya and other African countries are usually immune to malaria.  This immunity prevents them from becoming unwell, but even though healthy adults do not become unwell they nevertheless have low levels of malaria parasites in their blood.<br />\n <br />\n In order to find out if new malaria vaccines are working, scientists can use the following design after recruiting adults as trial participants; a) treating the trial participants with anti-malarials so as to clear any parasites that may be present in blood, b) administering the experimental vaccine, then c) following the trial participants with repeated blood tests to look for low-level malaria infections.  If the vaccine is working well it should be able to prevent new malaria infections.<br />\n <br />\n This study aims at determining the best anti-malarial drug regimen that will be used in these trials to clear parasites before carrying out tests to check if a vaccine is preventing one from acquiring new infections. We will therefore not administer any vaccine in this trial, since we are only interested in the correct choice of drug at this stage.  <br />\n <br />\n In this study, we shall divide the participants into three groups and compare the groups so as to find out which anti-malarial regimen clears all malaria parasites in the blood fastest and doesn’t have many side-effects. The anti-malarial drugs that we will use in this trial have already been approved for use. People will be divided into the groups using a system based on chance without any preference, such that everyone has the same chance of being in either group. We hope to include 90 healthy adults (men and women) with 30 in each malaria treatment group.<br />\n <br />\n What questions are we trying to answer?<br />\n <br />\n We wish to compare the ability of 3 different anti-malarial treatments to clear malaria parasites in the blood without persisting in the body after completion of treatment. We also wish to assess the side effects associated with the various anti-malarial treatments so as to find the one with the least side effects.<br />\n <br />\n Where is the study taking place, how many people does it involve, and how are they selected?  <br />\n <br />\n The study will be done in Kilifi district and will involve 90 healthy adult male and female volunteers aged between 18 and 50 years.<br />\n  <br />\n <br />\n What does the study involve for those who are in it?  <br />\n Following attainment of all the necessary approvals (Scientific, Ethical and Regulatory), community engagement process will begin with contact with the district health management team then other local administrative and community leaders within the catchment area. Public meetings will then be arranged in the study villages to inform the communities of the planned study then individuals will be invited to the informed consent process.<br />\n <br />\n Those willing to take part will have a health check to ensure they can take part in the study which will also include a 15ml venous blood sample. Those recruited into the study will be divided into 3 groups and will receive anti-malrial treatment as follows strating from day 0(day of enrollment); 1) Atovaquone/proguanil + Artesunate (3 days) 2) Artesunate (7 days) or 3) S/P + Artesunate + Primaquine. The clinic attendances will range from 27 to 30 depending on whether one will be on a 3 day or 7 day anti-malarial course clinic attendances will be a total of 25 blood sampling occasions. After enrollment, blood samples will be taken as follows; 3 times a week for 4 weeks, followed by twice weekly for 3 weeks and finally once weekly for 6 weeks. All these blood samples will be 1ml in volume except on day 44 and day 90 when a 5ml blood sample will be drawn.<br />\n <br />\n There shall be a field worker home visit in the course of the study to assess bed net usage. Pregnant and lactating women will be excluded from this trial. A pregnancy test will be done during screening, on the day of enrollment (day 0) and on day 7. This is because some anti-malarial drugs are not safe during pregnancy. It is however safe to become pregnant after the completion of the anti-malarial treatment.<br />\n <br />\n What are the benefits and risks of the study for those involved?  <br />\n No direct payments will be gained from participating in this study.<br />\n Participants will receive medical care for acute illness from the day of the first dose of vaccine until the completion of the study at no cost. This study will involve taking time off work and travel costs for participants. Participants will however be compensated for their time spent off their routine work to be in this study, for each clinic visit at a level commensurate with the lost wages as well as travel costs.<br />\n  <br />\n As with any other medication, some side effects may be seen with this malaria medication. These include nausea and vomiting, abdominal pain, headache and loss of appetite. One of the anti-malarials in this trial is known to decrease the amount of blood in the body for those whose liver is not able to break it down. However, we shall test all volunteers prior to administering the anti-malarial drugs and will not administer this anti-malarial to anyone whose liver is not able to break it down as well as not enrol anyone with abnormal liver function.<br />\n There may be some pain and bruising associated with blood drawing which will resolve after a few days. There is a small risk of infection. This risk is minimized by use of pre packaged sterile equipment and trained staff.<br />\n  How will the study benefit society?<br />\n This study is justified by the high incidence of malaria mortality and morbidity in Kenya and the rest of sub-Saharan Africa. While other malaria control measures are in place, they are still not able to eliminate malaria. A vaccine may provide that last effort to malaria control.  Anti-malarial drugs may be used in various malaria vaccine trials to clear parasites before assessing if one is acquiring new infections after vaccination.<br />\n <br />\n When does the study start and finish?<br />\n This study is planned to start early in the 3rd quarter of 2013 and will run for 6 months.<br />\n <br />\n  </p>\n
      • short_titleMalPaC Trial
      • protocol_noECCT/13/08/02
      • version_no1.1
      • date_of_protocol29-04-2013
      • study_drug1) Atovaquone/proguanil + Artesunate 2) Artesunate or 3) S/P + Artesunate + Primaquine.
      • disease_conditionMalaria
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_name1) Atovaquone/proguanil + Artesunate 2) Artesunate or 3) S/P + Artesunate + Primaquine.
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressctfuser@kemri-wellcome.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi0
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantCAROLINE OGWANG
      • declaration_date112-08-2013
      • declaration_principal_investigatorJUDY PESHU,PROJECT COORDINATOR
      • declaration_date212-08-2013
      • placebo_presentNo
      • study_objectives<p>\n General Objective<br />\n To evaluate three different drug regimens for use in a Phase IIb trial design that will eventually be used to test vaccine efficacy.<br />\n  <br />\n Specific Objectives<br />\n Primary objective<br />\n There are two co-primary objectives<br />\n <br />\n a)    To examine the proportion of participants positive by PCR 7 days following treatment with 3 different anti-malarials.<br />\n b)    To examine the proportion of participants positive by PCR on days 9 to 90 following treatment with 3 different anti-malarials.<br />\n <br />\n Secondary objectives<br />\n To assess whether low-level PCR positive results are live parasites as indicated by transcription of RNA (detected by Reverse Transcriptase- Polymerase Chain Reaction (RT-PCR)).<br />\n <br />\n To assess the tolerability of 3 different anti-malaria drug regimens used to clear malaria infection prior to PCR monitoring in adults.<br />\n <br />\n To assess the association between exposure to malaria as determined using serological responses to malaria antigens at the start and end of monitoring.<br />\n <br />\n To assess associations between pre-treatment frequencies of atypical memory B cells (as well as other B-cell phenotypes) with sero-conversion to malaria antigens upon re-infection during follow up.<br />\n <br />\n <br />\n  </p>\n
      • principal_inclusion_criteria<p>\n <u>Inclusion Criteria</u></p>\n<ul>\n <li>\n Consenting adults aged 18 – 50 years in good health.</li>\n <li>\n Will remain resident in the study area for the study duration.</li>\n <li>\n Able and willing (in the Investigator’s opinion) to comply with all study requirements</li>\n <li>\n Informed Consent</li>\n</ul>\n<p>\n <br />\n  </p>\n
      • principal_exclusion_criteria<p>\n <u>Exclusion criteria </u></p>\n<p>\n Any of the following constitutes exclusion criterion:</p>\n<ul>\n <li>\n Any significant medical disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.</li>\n <li>\n Haemoglobin less than 11.3 g/dl for men and less than 10g/dl for in women, where judged to be clinically significant in the opinion of the investigator.</li>\n <li>\n Blood transfusion within the month preceding enrolment.</li>\n <li>\n Current participation in another clinical trial or recent participation within 12 weeks of this study.</li>\n <li>\n Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial.</li>\n <li>\n Pregnant or lactating women.</li>\n <li>\n Women unwilling to use contraception for the duration of drug treatment.</li>\n <li>\n Likelihood of travel away from the study area</li>\n</ul>\n<p>\n <u>Withdrawal criteria</u></p>\n<p>\n Subjects may be withdrawn from the study:</p>\n<ul>\n <li>\n By withdrawing consent</li>\n <li>\n On the decision of the investigator</li>\n</ul>\n<p>\n The investigator may withdraw the subject for the following reasons:</p>\n<ul>\n <li>\n Any adverse event which results in the inability to comply with study procedures</li>\n <li>\n Ineligibility either arising during the study or retrospectively</li>\n <li>\n Significant protocol deviation.</li>\n <li>\n Loss to follow up (applies to a subject who consistently does not return for protocol study visits, is not reachable by telephone or any other means of communication and/ is not able to be located).</li>\n</ul>\n
      • primary_end_points<p align=\"JUSTIFY\" style=\"text-indent: 0.5in; line-height: 100%\">\n <font face=\"Times New Roman, serif\"><font size=\"3\">We will compare drug regimens for time to first episode of </font></font><font face=\"Times New Roman, serif\"><font size=\"3\"><i>P.falciparum</i></font></font><font face=\"Times New Roman, serif\"><font size=\"3\"> infection, defined as 2 or more consecutive blood samples </font></font></p>\n<p align=\"JUSTIFY\" style=\"text-indent: 0.5in; line-height: 100%\">\n <font face=\"Times New Roman, serif\"><font size=\"3\">confirmed positive by PCR, for </font></font><font face=\"Times New Roman, serif\"><font size=\"3\"><i>P.falciparum.</i></font></font><font face=\"Times New Roman, serif\"><font size=\"3\"><u><b> </b></u></font></font></p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:213px;\">\n Key investigators</td>\n <td style=\"width:213px;\">\n Qualification</td>\n <td style=\"width:213px;\">\n Experience</td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n  </td>\n <td style=\"width:213px;\">\n  </td>\n <td style=\"width:213px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n Caroline Ogwang</td>\n <td style=\"width:213px;\">\n MBChB</td>\n <td style=\"width:213px;\">\n Has been the lead clincian in a number of vaccine trials and has also been involved in drug trials.</td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p>\n Britta Urban   </p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Phd in immunology</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Has vast experience immunological work and analysis both interenally and externally.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p>\n Domtila Kimani</p>\n </td>\n <td style=\"width:213px;\">\n <pre>\nMSc in immunology</pre>\n <p>\n  </p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Has experience in immunological work and analysis in several trials.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p>\n Jedidah Mwacharo                             </p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Bsc in Science</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Has experience in immunological work and analysis in several trials.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p>\n Jimmy Shangala         </p>\n </td>\n <td style=\"width:213px;\">\n <p>\n BPharm</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Has vast experience in IMP management for drug and vaccine trials.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p>\n Patricia Njuguna                                </p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Mmed in Paediatrics</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Has vast experience in overseeing clinical trials and trial design.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p>\n Philip Bejon</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Phd in vaccinology</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Has vast experience in overseeing clinical trials and trial design both internally and externally. Has great experience in immunological work.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p>\n Ken Awuondo                                      </p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Msc in Biomedical science</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Is an experienced lab manager and has overseen sampla analysis for several trials.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n Judy Peshu</td>\n <td style=\"width:213px;\">\n Registered Community Nurse</td>\n <td style=\"width:213px;\">\n Has vast experience in co-ordinating clinical trials.</td>\n </tr>\n </tbody>\n</table>\n<p>\n Others include field workers, a data clerk, a data manager, lab technicians and a pharmacy technician.</p>\n<p>\n The trial site has drugs for managing adverse events. Any participant requiring specilaist care will be reffered to Kilifi District Hospital.</p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n N/A</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration6 months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaJunju
      • single_site_physical_addressJunju Dispensary
      • single_site_contact_personCaroline Ogwang
      • single_site_telephone+(254) 417 522043
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site90
      • total_participants_worldwide90
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameCaroline
      • investigator1_middle_nameAmolo
      • investigator1_family_nameOgwang
      • investigator1_qualificationMedical Officer, MBChB
      • investigator1_professional_addressPO Box 230-80108, Kilifi, Kenya
      • investigator1_telephone+254 41 7522 063
      • investigator1_emailcogwang@kemri-wellcome.org
      • organisations_transferred_No
      • number_participants90
      • notification
      • approval_date29-07-2013
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted17-08-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2020-08-17 10:35:44
      • created2013-06-27 10:38:35
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id101
        • application_id158
        • given_nameCaroline
        • middle_nameAmolo
        • family_nameOgwang
        • qualificationMedical Officer, MBChB
        • professional_addressPO Box 230-80108, Kilifi, Kenya
        • telephone+254 41 7522 063
        • emailcogwang@kemri-wellcome.org
        • created2013-06-27 10:49:32
        • modified2020-08-17 10:35:44
      • 1(array)
        • id103
        • application_id158
        • given_nameFrancis
        • middle_nameMaina
        • family_nameNdung\'u
        • qualificationPhD Immunology
        • professional_addressPO Box 230-80108, Kilifi, Kenya
        • telephone+254 41 7522 063
        • emailfndungu@kemri-wellcome.org
        • created2013-06-27 11:44:05
        • modified2020-08-17 10:35:44
    • SiteDetail(array)
      • 0(array)
        • id128
        • application_id158
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2013-06-27 10:49:32
        • modified2020-08-17 10:35:44
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id82
        • application_id158
        • sponsorKEMRI Wellcome Trust Research Programme
        • sponsor_typeResearch Institution
        • contact_personDr Philip Bejon
        • addressKEMRI Wellcome Trust Research Programme
        • telephone_number+254 41 7522 063
        • fax_number
        • cell_number+254708587210
        • email_addresspbejon@kemri-wellcome.org
        • created2013-06-27 10:49:32
        • modified2020-08-17 10:35:44
  • 3(array)
    • Application(array)
      • id157
      • user_id84
      • trial_status_id(null)
      • abstract_of_study<p style=\"margin: 0px 0px 10px;\">\n <strong style=\"color: rgb(51, 51, 51); font-family: \'Helvetica Neue\', Helvetica, Arial, sans-serif; font-size: 14px; line-height: 20px;\">HIV-1 uninfected individuals within HIV-1 discordant partnerships are at high-risk for HIV-acquisition. The majority of HIV-1 transmissions to adults in Africa occur within stable, HIV-1 discordant couples. Novel strategies to prevent HIV-1 transmission within discordant couples, especially interventions that might allow pregnancy to occur safely, are urgently needed. Pre-exposure chemoprophylaxis, in which an HIV-1 uninfected individual at high risk for contracting HIV-1 takes antiretroviral medications to maintain blood and genital drug levels sufficient to prevent HIV-1 acquisition, has been proposed as a potential HIV-1 prevention strategy. A randomized, blinded, placebo-controlled trial is required to demonstrate if PrEP decreases HIV-1 acquisition and has an acceptable safety profile when given to HIV-1 uninfected individuals within HIV-1 discordant partnerships.</strong></p>\n<p style=\"margin: 0px 0px 10px;\">\n <strong style=\"color: rgb(51, 51, 51); font-family: \'Helvetica Neue\', Helvetica, Arial, sans-serif; font-size: 14px; line-height: 20px;\">Both tenofovir disoproxil fumarate (TDF) and co-formulated emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) have been proposed as possible safe and effective medications to serve as pre-exposure chemoprophylaxis. The potential for differential safety, cost, and efficacy for these two medications justifies evaluating both, against placebo, in a single clinical trial. This trial will directly answer whether PrEP decreases HIV-1 acquisition among HIV-1 uninfected individuals within HIV-1 discordant couples, a very high-risk heterosexual population who could benefit from this type of intervention, if found to be safe and efficacious.</strong></p>\n
      • study_title<p style=\"margin: 0px 0px 10px;\">\n <strong style=\"color: rgb(51, 51, 51); font-family: \'Helvetica Neue\', Helvetica, Arial, sans-serif; font-size: 14px; line-height: 20px;\">Parallel Comparison of Tenofovir and Emtricitabine/tenofovir Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition within HIV-1 Discordant Couples</strong></p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/08/08/02
      • version_no3.0
      • date_of_protocol12-10-2007
      • study_drugTenofovir, Tenofovir/emtricitabine
      • disease_conditionHIV-1
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameViread, Truvada
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresspipscoordinatoreldoret@gmail.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries1
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantProf. Edwin Were
      • declaration_date115-07-2013
      • declaration_principal_investigatorDr. Nelly Mugo
      • declaration_date215-07-2013
      • placebo_presentYes
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n <strong><u>Inclusion Criteria for Potential HIV-1 uninfected (Partner) participants:  </u></strong></p>\n<p>\n •  Of legal age to provide independent informed consent for research per local regulations and guidelines</p>\n<p>\n • Age ≥18 and ≤65 </p>\n<p>\n •  Able and willing to provide written informed consent to be screened for and to take part in the study</p>\n<p>\n •  HIV-1 uninfected based on parallel negative HIV-1 rapid tests, both at study screening and at the enrollment visit </p>\n<p style=\"margin-left:164.65pt;\">\n  </p>\n<p>\n •  Able and willing to provide adequate locator information for study retention purposes, as defined by local standard operating procedures</p>\n<p style=\"margin-left:164.65pt;\">\n  </p>\n<p>\n •  Adequate renal function, defined by creatinine clearance ≥ 60ml/min estimated by the Cockcroft Creatinine Clearance Formula AND serum creatinine level of ≤ 1.3 mg/dL for men / ≤1.1 mg/dL for women, measured within 56 days of enrollment</p>\n<p style=\"margin-left:164.65pt;\">\n  </p>\n<p>\n •  Adequate hepatic function, defined by total bilirubin ≤1.5x upper limit of normal AND hepatic transaminases (ALT and AST) <2x upper limit of normal, measured within 56 days of enrollment</p>\n<p style=\"margin-left:164.65pt;\">\n  </p>\n<p>\n •  Adequate hematologic function, defined by absolute neutrophil count >1,300/mm³, platelets >125,000/mm³, and hemoglobin >11 g/dL, measured within 56 days of enrollment</p>\n<p style=\"margin-left:164.65pt;\">\n  </p>\n<p>\n •  Not infected with HBV, as determined by a negative hepatitis B surface antigen test, further defined in Appendix VI</p>\n<p style=\"margin-left:164.65pt;\">\n  </p>\n<p>\n •  Part of a heterosexual couple in which one partner meets the study eligibility criteria for index (HIV-1 infected) participants and the other partner meets the study eligibility criteria for partner (HIV-1 uninfected) participants, including the following  criteria for the couple:</p>\n<p style=\"margin-left:.75in;\">\n  </p>\n<p style=\"margin-left:.75in;\">\n •  are partners who are sexually active (defined as having had vaginal intercourse with the partner [HIV-1 uninfected] participant at least 6 times in the last three months) </p>\n<p style=\"margin-left:.75in;\">\n  </p>\n<p style=\"margin-left:.75in;\">\n •  plan to remain in the relationship for the duration of the study period.</p>\n<p style=\"margin-left:.75in;\">\n  </p>\n<p style=\"margin-left:.75in;\">\n  </p>\n<p>\n <strong><u>Inclusion Criteria for Potential HIV-1 infected (Index) participants:  </u></strong></p>\n<p>\n •  Of legal age to provide independent informed consent for research per local regulations and guidelines. </p>\n<p>\n  </p>\n<p>\n •  Able and willing to provide written informed consent to be screened for and to take part in the study.</p>\n<p style=\"margin-left:.25in;\">\n  </p>\n<p>\n •  Part of a heterosexual couple in which one partner meets the study eligibility criteria for index (HIV-1 infected) participants and the other partner meets the study eligibility criteria for partner (HIV-1 uninfected) participants.   </p>\n<p>\n  </p>\n<p>\n •  HIV-1 infected based on positive EIA. </p>\n<p>\n  </p>\n<p>\n •  CD4 cell count ≥250 cells/mm³ and not otherwise meeting national guidelines for initiation of antiretroviral therapy. </p>\n<p>\n  </p>\n<p>\n •  No history of any clinical AIDS-defining diagnoses.</p>\n<p>\n  </p>\n<p>\n •  Able and willing to provide adequate locator information for study retention purposes, as defined by local standard operating procedures.</p>\n<p>\n  </p>\n
      • principal_exclusion_criteria<p>\n <strong><u>Exclusion Criteria for Potential HIV-1 uninfected (Partner) participants:  </u></strong></p>\n<p>\n •  Current pregnancy, or planning to become pregnant during the study period</p>\n<p>\n  </p>\n<p>\n • Current breastfeeding</p>\n<p>\n •  Must not be currently enrolled in another HIV-1 vaccine or prevention trial.</p>\n<p style=\"margin-left:164.65pt;\">\n  </p>\n<p>\n •  Known plans to re-locate or travel away from the study site for more than two consecutive months during the study period.</p>\n<p style=\"margin-left:164.65pt;\">\n  </p>\n<p>\n •  Repeated positive (≥1+) urine dipstick tests for glycosuria or  proteinuria. Participants with definite evidence of glucose and/or protein in their urine will not be eligible.  If a urine dipstick is positive for either glucose and/or protein at the first screening visit, a second urine sample will be tested. </p>\n<p style=\"margin-left:164.65pt;\">\n  </p>\n<p>\n •  Active and serious infections, including active tuberculosis infection or osteomyelitis and all infections requiring parenteral antibiotic therapy; active clinically significant medical problems including cardiac disease (e.g., symptoms of ischemia, congestive heart failure or arrhythmia), pulmonary disease (steroid dependent chronic obstructive pulmonary disease), diabetes requiring hypoglycemic medication; and previously diagnosed malignancy expected to require further treatment.</p>\n<p style=\"margin-left:182.65pt;\">\n  </p>\n<p>\n •  History of pathological bone fractures not related to trauma</p>\n<p style=\"margin-left:164.65pt;\">\n  </p>\n<p>\n •  Receiving ongoing therapy with any of the following: antiretroviral therapy (ART), including nucleoside analogs, nonnucleoside reverse transcriptase inhibitors, protease inhibitors or investigational antiretroviral agents, interferon (alpha, beta, or gamma) or interleukin (e.g., IL-2) therapy,  metformin, aminoglycoside antibiotics, amphotericin B, cidofovir, systemic chemotherapeutic agents, other agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion (e.g., probenecid), and/or other investigational agents</p>\n<p style=\"margin-left:164.65pt;\">\n  </p>\n<p>\n •  At enrollment, has any other condition that, based on the opinion of the investigator or designee, would preclude provision of informed consent; make participation in the study unsafe; complicate interpretation of study outcome data; or otherwise interfere with achieving the study objectives (including, for couples previously enrolled in the Partners in Prevention HSV/HIV Transmission Trial, having more than 2 missed visits or more than 2 visits outside the visit window)</p>\n<p>\n  </p>\n<p>\n <strong><u>Exclusion Criteria for Potential HIV-1 infected (Index) participants:  </u></strong></p>\n<p>\n •  Current use of antiretroviral therapy</p>\n<p style=\"margin-left:164.65pt;\">\n  </p>\n<p>\n •  Currently enrolled in another HIV-1 treatment trial</p>\n<p style=\"margin-left:164.65pt;\">\n  </p>\n<p>\n •  At enrollment, has any other condition that, based on the opinion of the investigator or designee, would preclude provision of informed consent; make participation in the study unsafe; complicate interpretation of study outcome data; or otherwise interfere with achieving the study objectives (including, for couples previously enrolled in the Partners in Prevention HSV/HIV Transmission Trial, having more than 2missed visits or more than 2 visits outside the visit window)</p>\n<p style=\"margin-left:182.65pt;\">\n  </p>\n
      • primary_end_points<p style=\"margin-left:56.65pt;\">\n Incident HIV-1 infection will be the primary study endpoint and will be defined as</p>\n<p style=\"margin-left:56.65pt;\">\n i) serologically confirmed incident HIV-1 <span style=\"font-size: 12px;\">infection, with the exception that the enrollment sample from any partner (HIV-1 </span><span style=\"font-size: 12px;\">uninfected) participant who is serologically positive at a visit within the first three months </span><span style=\"font-size: 12px;\">after enrollment will be tested for HIV-1 RNA by PCR.  Detectable HIV-1 RNA at </span><span style=\"font-size: 12px;\">enrollment will indicate infection prior to randomization and this individual will be </span><span style=\"font-size: 12px;\">excluded from efficacy analyses; </span></p>\n<p style=\"margin-left:56.65pt;\">\n <span style=\"font-size: 12px;\">ii)  HIV-1 RNA >50 copies/ml by PCR at the last study </span><span style=\"font-size: 12px;\">visit of any subject – in particular, individuals who are RNA positive at Stop Visit who </span><span style=\"font-size: 12px;\">then seroconvert at the post-study drug visit; iii) other incident HIV-1 infections as </span><span style=\"font-size: 12px;\">determined and documented by the endpoint review committee (see below).  Sequence </span><span style=\"font-size: 12px;\">matching of index (HIV-1 infected) and seroconverting partner HIV-1 viral clones will be </span><span style=\"font-size: 12px;\">performed for the purpose of facilitating the secondary study objective of evaluating the </span><span style=\"font-size: 12px;\">impact of index (HIV-1 infected) participant factors (e.g., HIV-1 plasma viral load) on </span><span style=\"font-size: 12px;\">PrEP efficacy.  </span></p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<table align=\"center\" border=\"1\" cellpadding=\"0\" cellspacing=\"0\" width=\"727\">\n <tbody>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n  </p>\n <p align=\"left\">\n <strong><em>NAME</em></strong></p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n  </p>\n <p align=\"left\">\n <strong><em>TITLE/ROLE</em></strong></p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n  </p>\n <p align=\"left\">\n <strong><em>QUALIFICATION</em></strong></p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n  </p>\n <p align=\"left\">\n <strong><em>STUDY START DATE</em></strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 1. Prof. Edwin Were</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n Site Principal Investigator</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n MBChB, MMed, MPH</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n Sept 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 2. Prof. Ken Fife</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n Principal Investigator (Indiana)</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n MD, PhD</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n Sept 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 3. Prof. Paul Ayuo</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n Co-PI, Clinical Consultant</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n MBChB, MMed, MSc</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n Sept 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 4. Dr. Dismas Oketch</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n Site Coordinator</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n MBChB, MSc</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n Nov 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 5. Jairus K Cheruiyot</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n Study Clinical Officer</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n Dip Clinical Medicine</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n Sept 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 6. Jacinta Sawe</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n Community Health Educator</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n KRCHN, BSc</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n Nov 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 7. Nereo Murgor</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n Lead Nurse Counselor</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n BSN</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n Nov 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;height:5px;\">\n <p align=\"left\">\n 8. Eunice Kaguiri</p>\n </td>\n <td style=\"width:236px;height:5px;\">\n <p align=\"left\">\n Senior Data Manager</p>\n </td>\n <td style=\"width:147px;height:5px;\">\n <p align=\"left\">\n BSc, MPH</p>\n </td>\n <td style=\"width:144px;height:5px;\">\n <p align=\"left\">\n Sept 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 9. Wilfred Emonyi</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n Lab Manager (AMPATH)</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n PhD</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n Sept 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;height:5px;\">\n <p align=\"left\">\n 10. Juda Kimuge</p>\n </td>\n <td style=\"width:236px;height:5px;\">\n <p align=\"left\">\n Study Laboratory Technologist</p>\n </td>\n <td style=\"width:147px;height:5px;\">\n <p align=\"left\">\n BSc</p>\n </td>\n <td style=\"width:144px;height:5px;\">\n <p align=\"left\">\n Non 2008</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;height:5px;\">\n <p align=\"left\">\n 11. Ogola C. Achieng</p>\n </td>\n <td style=\"width:236px;height:5px;\">\n <p align=\"left\">\n Phlebotomist, Lab Assistant</p>\n </td>\n <td style=\"width:147px;height:5px;\">\n <p align=\"left\">\n Cert. Phlebotomy</p>\n </td>\n <td style=\"width:144px;height:5px;\">\n <p align=\"left\">\n Sept 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;height:5px;\">\n <p align=\"left\">\n 12. Alicen Jepkemei Komen</p>\n </td>\n <td style=\"width:236px;height:5px;\">\n <p align=\"left\">\n Lead Pharmacy Technologist</p>\n </td>\n <td style=\"width:147px;height:5px;\">\n <p align=\"left\">\n Dip Pharmacy</p>\n </td>\n <td style=\"width:144px;height:5px;\">\n <p align=\"left\">\n Sept 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 13. Francis M. Mudogo</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n Accountant/Administrator</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n KATC, CPA</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n Sept 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 14. Mbinda Ellionorah</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n Study Secretary/receptionist</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n KNEC</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n Sept 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 15. Kutwa Godfrey</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n CHCT Counselor</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n CHCT Counselor</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n Sept 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 16. Christine Kapere</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n CHCT Counselor</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n CHCT Counselor</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n Sept 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 17. Gatetua Mungai</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n VCT Liaison</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n KRCHN</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n Sept 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 18. Joyce B. Baliddawa</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n Behavioral Consultant</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n PhD</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n Sept 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 19. Stella Kerubo</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n Office Asst</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n KIPC</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n May 2008</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 20. Charles Odhiambo</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n Driver/Outreach Worker</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n Dip Marketing</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n Sept 2007</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"4\" style=\"width:727px;\">\n <p align=\"left\">\n  </p>\n <p align=\"left\">\n <strong><em>SITE FACILITIES, EQUIPMENT & OTHER RESOURCES</em></strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n Site IEC/IRB</p>\n </td>\n <td colspan=\"3\" style=\"width:527px;\">\n <p align=\"left\">\n Moi University/Moi Teaching and Referral Hospital, Institutional Research and Ethics Committee (MU/MTRH IREC). IREC has been mandated to review and approve protocols on behalf of the National Council of Science and Technology (the national regulatory authority). IREC has a Federal wide Assurance No. FWA 00003128. IREC is composed of 17 members (representing the Schools of Medicine, Nursing, Dentistry, Public Health and the Teaching and Referral Hospital and the community) that meet monthly to review protocols. </p>\n <p align=\"left\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n Study facility &Equipment</p>\n </td>\n <td colspan=\"3\" style=\"width:527px;\">\n <p align=\"left\">\n The site is located at the Partners House along Nandi Road. It comprises 18 rooms: The Coordinator’s Office, the Accountant/Administrator’s Office, 1 Data Room, 1 Outreach Office, 1 Staff Room, 1 Pharmacy Room., 4 Counselling/Consenting Rooms, 4 Self-contained Clinical/Examination Rooms, 1 Store, 1 training/Conference Room, 1 Archive and a Reception/Waiting Area. The facility is equipped with reliable internet & telephone connection; desktop & laptop computers; printers; photocopiers, data fax machines, filing cabinets & vehicles. All equipments are maintained and calibrated accordingly</p>\n <p align=\"left\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n Site Laboratory</p>\n </td>\n <td colspan=\"3\" style=\"width:527px;\">\n <p align=\"left\">\n The site incorporates the AMPATH Reference Laboratory providing access to all required facilities for this study, specifically: three -80C and four -20C freezers and multiple centrifuges.  The laboratory is staffed by appropriately trained personnel ensuring that IATA regulations for the shipping of biological samples are adhered to.  A Quality Control system is in place that ensures all procedures are performed according to GCLP & GLP standards. The lab is accredited by KENAS and awarded ISO 15189:2007 Accreditation. The laboratory provides services to the AMPATH program and all clinical trials under Moi University College of Health Sciences.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n Site Pharmacy</p>\n </td>\n <td colspan=\"3\" style=\"width:527px;\">\n <p align=\"left\">\n There is a study pharmacy ensuring that all study medications can be stored, dispensed and returned in accordance with study requirements; for this study, product will be stored in an access-controlled environment and maintained at a temperature between 15-30^oC .</p>\n <p align=\"left\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n Consulting Rooms</p>\n <p align=\"left\">\n  </p>\n </td>\n <td colspan=\"3\" style=\"width:527px;\">\n <p align=\"left\">\n The site is set-up to ensure private consulting rooms ensuring confidentiality when consenting and during subject visits.  Separate counseling rooms are available, if required. </p>\n <p align=\"left\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n Emergency Facilities</p>\n <p align=\"left\">\n  </p>\n </td>\n <td colspan=\"3\" style=\"width:527px;\">\n <p align=\"left\">\n A comprehensive emergency service (Moi Teaching & Referral Hospital) is accessible within minutes. The hospital has an inpatient bed capacity of 800 and admits 27,741 adults and 9545 children annually. The hospital has close to 200 doctors specialized in various fields of medicine, pediatrics, obstetrics and gynecology, surgery, psychiatry, critical care and medical research.</p>\n </td>\n </tr>\n </tbody>\n</table>\n<div style=\"clear:both;\">\n  </div>\n
      • other_details_explanation<p style=\"margin-left:56.65pt;\">\n The HIV-1 pandemic continues to have the greatest impact in sub-Saharan Africa, where 25 million of the estimated 40 million adults and children living with HIV/AIDS worldwide reside. Before undertaking the Partners PrEP Study, the University of Washington’s International Clinical Research Center has previously sponsored another HIV-1 prevention study among HIV Discordant couples across 11 countries in Sub-Saharan Africa between 2004 and 2008 [the HSV-2/HIV-1 Acyclovir Study].</p>\n<p style=\"margin-left:56.65pt;\">\n It has been reported that Kenya and Uganda were chosen because of advanced or well organinsed [HIV] research infrastructure and fairly better described epidemiological data.</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p style=\"margin-left:92.65pt;\">\n ·         University of Washington, Human Subjects Division, formal approval  dated 1^st October 2007</p>\n<p style=\"margin-left:92.65pt;\">\n ·         Indiana University-Perdue University Indianapolis, IRB formal approval dated 11^th January 2008</p>\n<p style=\"margin-left:92.65pt;\">\n ·         Moi University Moi Teaching and Referral Hospital IREC formal approval dated 5^th March, 2008</p>\n<p style=\"margin-left:92.65pt;\">\n ·         Pharmacy and Poisons Board formal approval dated 25^th August, 2008</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration5 years
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherYes
      • design_controlled_specify3-arm study
      • design_controlled_comparatorPlacebo
      • design_controlled_other_medicinalYes
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states2
      • number_of_sites4
      • multi_country_listKenya, Uganda
      • data_monitoring_committeeYes
      • total_enrolment_per_siteEldoret site (976 participants), Thika site (496), Nairobi site (485) and Kisumu site (629 participants)
      • total_participants_worldwide9, 516
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameNelly
      • investigator1_middle_nameRwamba
      • investigator1_family_nameMugo
      • investigator1_qualificationMBChB, MMed (O/G), MPH
      • investigator1_professional_addressKenyatta National Hospital, UNITID Building, 3rd Floor, Room 302
      • investigator1_telephone254 733 629 665
      • investigator1_emailrwamba@csrtkenya.org
      • organisations_transferred_No
      • number_participants4000 - 6400
      • notification<p>\n We thank the PPB particularly the ECCT for the continuing guidnace and support the conduct of relevant and impactful clinical reaearch in Kenya</p>\n
      • approval_date25-07-2008
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted17-07-2013
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2013-08-05 09:56:30
      • created2013-06-25 13:56:59
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id100
        • application_id157
        • given_nameEdwin
        • middle_nameOnyango
        • family_nameWere
        • qualificationAssociate Professor of Reproductive Health: MBChB, MMed (O/G), MPH
        • professional_addressMoi University School of Medicine, Department of Reproductive Health,P.O. Box 4606, Eldoret
        • telephone+254 733 759 942
        • emaileowere@gmail.com
        • created2013-06-25 15:14:51
        • modified2013-07-17 09:41:45
    • SiteDetail(array)
      • 0(array)
        • id127
        • application_id157
        • county_id27
        • site_nameEldoret Site
        • physical_addressMoi University, School of Medicine, Partners in Prevention, Partners House, Nandi Road
        • contact_detailsP.O. Box 4606. Eldoret; Tel +254 734 256 186, +254 720 473 785
        • contact_personDr. Dismas Oketch
        • site_capacity(null)
        • misc(null)
        • created2013-06-25 15:14:51
        • modified2013-07-17 09:41:45
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
      • 1(array)
        • id137
        • application_id157
        • county_id42
        • site_nameKisumu Site
        • physical_addressCIS Project, KEMRI-UCSF Building, Lumumba Health Center, Agoi Street
        • contact_detailsP.O. Box 614, Kisumu; Tel +254 733276 275
        • contact_personJosephine Odoyo
        • site_capacity(null)
        • misc(null)
        • created2013-07-11 13:54:57
        • modified2013-07-17 09:41:45
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id138
        • application_id157
        • county_id22
        • site_nameThika Site
        • physical_addressThika Partners in Prevention House, next to Thika Nursing Home, Section 9
        • contact_details+254 6722561
        • contact_personDr. Kenneth Ngure
        • site_capacity(null)
        • misc(null)
        • created2013-07-11 13:54:57
        • modified2013-07-17 09:41:45
        • County(array)
          • id22
          • county_nameKiambu
          • created2012-06-15 10:24:37
          • modified2012-06-15 10:24:37
      • 3(array)
        • id139
        • application_id157
        • county_id47
        • site_nameNairobi Site
        • physical_addressKenyatta National Hospital, Couples Counselling Center
        • contact_details+254 202 344 344
        • contact_personCarol Ndungu
        • site_capacity(null)
        • misc(null)
        • created2013-07-11 13:54:57
        • modified2013-07-17 09:41:45
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id81
        • application_id157
        • sponsorUniversity of Washington, International Clinical Research Center
        • sponsor_type(null)
        • contact_personConnie Celum
        • addressBox 359927, 325 Ninth Avenue, Seattle, WA 98104 USA
        • telephone_number206 520 3825
        • fax_number206 520 3831
        • cell_number206 915 8972
        • email_addressccelum@u.washington.edu
        • created2013-06-25 15:14:51
        • modified2013-07-17 09:41:45
  • 4(array)
    • Application(array)
      • id155
      • user_id73
      • trial_status_id7
      • abstract_of_study<p>\n <strong>Design </strong>: Longitudinal Cohort Study</p>\n<p>\n <strong>Population</strong>: HIV-1 infected boys and girls age 9-14 years without clinical AIDS</p>\n<p>\n <strong>Study Size</strong>: 100 girls and 80 boys</p>\n<p>\n <strong>Treatment Plan</strong>: Three doses of intramuscular quadrivalent HPV vaccine 'Gardasil' administered at enrolment, month 2 and month 6.</p>\n<p>\n <strong>Study Duration</strong>: Each participant will be in the study for a total of 12 months.</p>\n<p>\n <strong>Outcome Variable</strong>: Antibody response to HPV vaccine will be tested at enrolment, month 7 and month 12. Second variable will be an assessment of safety and tolerability to the vaccine.</p>\n<p>\n <strong>Primary Objective</strong>: To determine the immunogenicity of quadrivalent HPV vaccine among HIV infected girls and boys age 9-14 years in Kenya.</p>\n<p>\n <strong>Secondary Objective: </strong></p>\n<ol>\n <li>\n To correlate the immune response, as measured by antibody titers, with the degree of immunosuppression</li>\n <li>\n To assess safety and tolerability to the HPV vaccine among HIV infected girls and boys age 9-14 years.</li>\n</ol>\n<p>\n <strong>Study Location</strong>: Partners in Prevention, Thika site, OAU Road, Off Kenyatta Avenue Section 9</p>\n
      • study_title<p>\n Immunogenicity and Safety of quadrivalent human Papillomavirus Vaccine in HIV-Infected pre-adolescent girls and boys in Kenya.</p>\n
      • laymans_summary<p>\n HPV is a common sexually transmitted infection that affects 80% of women and 65-70% of men.  The majority of HPV infections occur soon after a person becomes sexually active, typically between the ages of 14-24 years.  A vaccine called GARDASIL® can protect against some types of HPV (6, 11, 16 & 18). Cervical cancer affects the mouth of the uterus (cervix), and is the second commonest cancer among women. Half a million women get this cancer each year and of those who get cervical cancer, about half die. The majority of women who get cervical cancer live in sub Saharan African countries like Kenya. This disease can be prevented if detected before it becomes cancerous using a Pap smear. Most of the time, certain types of HPV (called Type 6, Type 11, Type 16, and Type 18) are responsible for cervical cancer, cancers of the vulva or vagina, precancerous cervical, vaginal and vulva lesions, and genital warts. Studies on vaccines have already been done in children who do not have HIV, and the vaccine is already being used to protect against the above diseases. The aim of this study is to confirm the safety, usefulness and long term effectiveness of this vaccine in HIV positive children so that they can get the benefits from this vaccine and assist investigators to determine the need for booster dosing.</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n
      • short_titleHIV/HPV-Adolescent Study
      • protocol_noECCT/12/02/02
      • version_no1.0
      • date_of_protocol27-06-2011
      • study_drugGardasil
      • disease_conditionHumanpapillomavirus infection
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressRwamba@csrtkenya.org
      • applicant_covering_letter1
      • applicant_protocol1
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      • declaration_applicantDr. Kenneth Ngure
      • declaration_date101-07-2011
      • declaration_principal_investigatorDr. Nelly Rwamba Mugo, Principal Investigator
      • declaration_date201-07-2010
      • placebo_presentNo
      • study_objectives<p>\n <strong>Aim 1:</strong> To assess sustained efficacy for up to 48 months of the quadrivalent human papillomavirus vaccine (Gardasil®) vaccine in HIV infected girls and boys ages 9-14 in Kenya.</p>\n<p>\n <strong>Aim 2</strong>:  To determine factors associated with sustained IgG LIA antibody after 3 doses of quadrivalent HPV vaccination such as sex, age, immune reconstitution with highly active antiretroviral therapy as determined by CD4 cell %, plasma HIV RNA and WHO disease stage classification</p>\n<p>\n <strong>Aim 3: </strong>To assess incidence of genital oncogenic HPV and HPV- type 6, 11 infections among sexually active  HIV infected adolescent vaccinated with 3 doses of quadrivalent HPV vaccination</p>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n 1.Laboratory confirmed HIV infection</p>\n<p>\n 2.Age range 9-14 years</p>\n<p>\n 3.Parental or guardian consent and participant assent</p>\n
      • principal_exclusion_criteria<p>\n 1. Severly ill as defined by Karnofsky score (<span style=\"color: rgb(0, 0, 0);\">< 70</span>)</p>\n<p>\n 2.A diagnosis of malignancy</p>\n<p>\n 3.On-going febrile illness (temperature ≥ 37.8 degrees celsius) including active treatment of an opportunistic infection.</p>\n<p>\n 4.Have received systemic corticosteroids within prior one year.</p>\n<p>\n 5.Have received inactivated vaccine within prior 2 weeks, or live attenuated vaccine within prior 6 weeks.</p>\n<p>\n 6.History of allergy to any products included in the HPV vaccine.</p>\n<p>\n 7.Have received any of blood derivatives within prior 6 months</p>\n<p>\n 8.Are Pregnant</p>\n<p>\n 9.Lack of parental consent and/or child declines to provide assent.</p>\n<p>\n  </p>\n<p>\n  </p>\n
      • primary_end_points<p>\n To determine the immunogenicity of quadrivalent HPV vaccine among HIV infected girls and boys ages 9-14 in Kenya.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n Thika partners in Prevention, Site has 32 full time clinical trial staff (including physicians, nurses, counsellors, pharmacists).</p>\n<p>\n Principal Investigator: Dr. Nelly R. Mugo  MBCHB,MMED,MPH</p>\n<p>\n Study coordinator/Co-invetigator: Dr. Kenneth Ngure  BSc,MPH,MSc,PhD</p>\n<p>\n Lead Physician: Dr. Njambi Njuguna  MBCHB, MPH</p>\n
      • other_details_explanation<p>\n The Principal Investigator is Kenyan and has proposed to conduct this single site study to provide data on immunogenicity of Gardasil Vaccine among HIV infected boys and girls. Notably, Gardasil Vaccine is already registered for use in Kenya for the general population.</p>\n
      • other_details_regulatory_notapproved<p>\n None pending</p>\n
      • other_details_regulatory_approved<p>\n 1.KNH/UON-ERC Approved 1 site in Kenya (Thika) on February 2, 2012</p>\n<p>\n 2.University of Washington IRB, approved 1 site in Kenya (Thika) on January 6, 2012</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration48 Months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaThika
      • single_site_physical_addressPartners in Prevention, Thika site, OAU Road, Off Kenyatta Avenue Section 9
      • single_site_contact_personDr. Nelly R. Mugo
      • single_site_telephone06722561
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_siteN/A
      • total_participants_worldwide180
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersYes
      • subjects_others_specifyHIV POSITIVE BOYS AND GIRLS AGE 9-14
      • investigator1_given_nameDr. Nelly
      • investigator1_middle_nameRwamba
      • investigator1_family_nameMugo
      • investigator1_qualificationMBCHB, MMED, MPH
      • investigator1_professional_address19865-00202
      • investigator1_telephone067-22561, 0723914057
      • investigator1_emailRwamba@csrtkenya.org
      • organisations_transferred_Yes
      • number_participants180
      • notification<p>\n This study has already been approved.</p>\n
      • approval_date22-05-2012
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted18-06-2021
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      • balance_site(null)
      • final_date(null)
      • modified2025-03-05 13:43:11
      • created2013-06-24 14:12:57
      • total_sites(null)
      • ecitizen_invoice(null)
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      • 0(array)
        • id99
        • application_id155
        • given_nameDr. Nelly
        • middle_nameRwamba
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        • qualificationMBCHB,MMED, MPH
        • professional_address19865-00202
        • telephone067-22561, 0723914057
        • emailRwamba@csrtkenya.org
        • created2013-06-25 11:03:30
        • modified2021-06-18 15:57:30
    • SiteDetail(array)
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        • id126
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        • county_id(null)
        • site_name
        • physical_address
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        • contact_person
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        • misc(null)
        • created2013-06-25 11:03:30
        • modified2021-06-18 15:57:30
        • County(empty)
    • Sponsor(array)
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        • id80
        • application_id155
        • sponsorMerck Investigators Study Program (MISP)
        • sponsor_typeIndustry
        • contact_personDr. Nelly R. Mugo
        • address19865-00202
        • telephone_number067-22561
        • fax_number
        • cell_number0723914057
        • email_addressRwamba@csrtkenya.org
        • created2013-06-25 11:03:30
        • modified2021-06-18 15:57:30
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App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

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• 1/var/www/html/ctr/lib
• 3/usr/share/php
• 4-> /var/www/html/ctr/lib/Cake/

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