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• trial_statuses(array)
  • 1Recruiting
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  • 3Suspended
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  • 8Writing-up
  • 9Application withdrawn
• applications(array)
  • 0(array)
    • Application(array)
      • id143
      • user_id21
      • trial_status_id5
      • abstract_of_study<p>\n Schema Attached as a separate PDF document</p>\n
      • study_title<p>\n <strong>A5225</strong><strong>/HiFLAC</strong>: <strong>A Phase I/II Dose-Finding Study of High-Dose Fluconazole Treatment in AIDS-Associated Cryptococcal Meningitis</strong></p>\n
      • laymans_summary(null)
      • short_titleHigh-Dose Fluconazole Treatment in AIDS-Associated CM
      • protocol_noECCT/10/03/03
      • version_no2.0
      • date_of_protocol11-05-2012
      • study_drugFluconazole
      • disease_conditionCryptococcal Meningitis
      • 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_nameDiflucan
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressaksudoi@hotmail.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_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
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      • applicant_prev_data(null)
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      • 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_applicantAllan K Sudoi
      • declaration_date107-06-2013
      • declaration_principal_investigatorAbraham M Siika, MBChB, MMed, Msc - Site Principal Investigator
      • declaration_date207-06-2013
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<h3>\n Inclusion Criteria – Step 1</h3>\n<ol>\n <li>\n Cryptococcal meningitis documented either by a positive CSF cryptococcal culture, a positive CSF India ink preparation, or a positive CSF cryptococcal antigen latex agglutination test within 7 days prior to entry.</li>\n <li value=\"2\">\n CSF collection for quantitative cryptococcal culture within 72 hours prior to study entry or planned to be performed at study entry.</li>\n <li value=\"3\">\n HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by or within 10 days after study entry by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.</li>\n</ol>\n<p style=\"margin-left:72.0pt;\">\n NOTE: The term ‘licensed’ refers to an FDA-approved kit which is required for all IND studies. For non-US sites, ‘licensed’ refers to a kit that has been certified or licensed by an oversight body within that country and that has been validated internally. However, non-US sites are encouraged to use FDA-approved methods for IND studies.</p>\n<p style=\"margin-left:72.0pt;\">\n The World Health Organization and the US Centers for Disease Control and Prevention guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (eg, indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.</p>\n<ol>\n <li value=\"4\">\n Men and women age ³ 16 years.</li>\n <li value=\"5\">\n Ability to take oral medications.</li>\n</ol>\n<p style=\"margin-left:72.0pt;\">\n NOTE: Administration of fluconazole tablets via nasogastric tube is permitted.</p>\n<ol>\n <li value=\"6\">\n For patients with a co-morbid complication of HIV, including opportunistic infections, receipt of stable treatment for the co-morbid complication and clinically stable, as judged by the site investigator. </li>\n</ol>\n<p style=\"margin-left:72.0pt;\">\n NOTE: Stable treatment is defined as treatment that has been taken for at least 2 weeks without change in dose or formulation of any of its components.</p>\n<ol>\n <li value=\"7\">\n For female participants of reproductive potential (defined as girls who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months, ie, who have had menses within the preceding 24 months, or have not undergone surgical sterilization [eg, hysterectomy, or bilateral oophorectomy or salpingotomy]) a negative serum or urine pregnancy test result must be obtained within 2 days prior to study entry.</li>\n <li value=\"8\">\n All participants must agree not to participate in the conception process (eg, active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization).</li>\n <li value=\"9\">\n If participating in sexual activity that could lead to pregnancy, female study participants must agree to the simultaneous use of two forms of contraceptive (from the list below) during such sexual activity, and male study participants must agree to use a condom during such sexual activity. This requirement continues while the study participant is on study treatment and for 6 weeks after fluconazole has been discontinued.</li>\n</ol>\n<ul>\n <li>\n Condoms (male or female) with or without a spermicidal agent</li>\n <li>\n Diaphragm or cervical cap with spermicide</li>\n <li>\n IUD (intrauterine device)</li>\n <li>\n Injectable DepoProvera</li>\n <li>\n Tubal ligation</li>\n</ul>\n<p style=\"margin-left:72.0pt;\">\n NOTE: Use of oral hormone-based contraceptives is prohibited while a study participant is taking any study-provided fluconazole.</p>\n<ol>\n <li value=\"10\">\n Study participants who are not of reproductive potential (defined as women who have been post-menopausal for at least 24 consecutive months, or women who have undergone surgical sterilization [eg, hysterectomy, or bilateral oophorectomy or salpingectomy], or men who have documented azoospermia), are eligible without the requirement to use contraceptives.</li>\n</ol>\n<p style=\"margin-left:72.0pt;\">\n NOTE: Lack of reproductive potential requires written documentation or oral communication from a clinician or clinician’s staff documented in source documents.</p>\n<ol>\n <li value=\"11\">\n Willingness and ability to adhere to dose schedules and mandatory procedures.</li>\n <li value=\"12\">\n Measured or calculated creatinine clearance of ≥50 mL/min within 3 days prior to study entry.</li>\n</ol>\n<p style=\"margin-left:72.0pt;\">\n A calculator is available at the Data Management Center at <a href=\"https://www.fstrf.org/ACTG/\">https://www.fstrf.org/ACTG/</a> or at <a href=\"http://www.fstrf.org/ACTG/index.html\">http://www.fstrf.org/ACTG/index.html</a>.</p>\n<ol>\n <li value=\"13\">\n The following laboratory values within 3 days prior to study entry:</li>\n</ol>\n<ul>\n <li>\n aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≤ 5 X the upper limit of normal (ULN)</li>\n <li>\n total bilirubin ≤ 2.5 X ULN</li>\n <li>\n absolute neutrophil count (ANC) ≥ 750/mm³</li>\n <li>\n platelet count ≥ 50,000/mm³</li>\n <li>\n hemoglobin ³ 7.0 g/dL</li>\n</ul>\n<ol>\n <li value=\"14\">\n Ability and willingness of the participant or legal guardian/representative to give informed consent.</li>\n <li value=\"15\">\n Availability at the site of at least 2 weeks of its standard of care ampho B-based regimen.</li>\n</ol>\n<h3>\n Inclusion Criteria – Step 2</h3>\n<ol>\n <li>\n Randomization to an ampho B-based regimen in Step 1.</li>\n <li value=\"2\">\n Receipt of at least one dose of ampho B-based regimen in Step 1.</li>\n <li value=\"3\">\n Premature discontinuation of ampho B in response to the occurrence of any treatment-limiting toxicity, as described in section 5 of the A5225/HiFLAC MOPS.</li>\n</ol>\n<h3>\n Inclusion Criteria - Step 3</h3>\n<ol>\n <li>\n For participants in Step 1 who are currently receiving study-provided fluconazole, with no plans to discontinue study treatment, a negative CSF culture after 2 weeks incubation from a sample obtained at or before week 6 (days 35-49).</li>\n <li value=\"2\">\n For participants in Step 1 who are currently receiving an ampho B-based regimen or alternative treatment, completion of approximately 2 weeks of treatment.</li>\n</ol>\n<p style=\"margin-left:72.0pt;\">\n NOTE: The total amount of ampho B received by a participant is expected to be approximately 8.4 mg/kg.</p>\n<ol>\n <li value=\"3\">\n For participants in Step 2 who are currently receiving study-provided fluconazole, with no plans to discontinue study treatment, negative CSF culture after 2 weeks incubation from a sample obtained at or before week 6 (day 35-49).</li>\n</ol>\n<h3>\n Inclusion Criteri<strong>on</strong> – Step 4</h3>\n<ol>\n <li>\n On study treatment at week 10 (day 63-77)<strong>, with no plans to discontinue study treatment</strong></li>\n</ol>\n<p>\n  </p>\n
      • principal_exclusion_criteria<h3>\n Exclusion Criteria - Step 1</h3>\n<ol>\n <li>\n Expected survival of ≤ 2 weeks, in the opinion of the site investigator and, if available, the primary care provider.</li>\n <li value=\"2\">\n For patients with a co-morbid complication of HIV, anticipated difficulty, in the opinion of the site investigator, in judging response to study treatment as a result of the co-morbid complication or the drugs used to treat it.</li>\n <li value=\"3\">\n Breastfeeding.</li>\n <li value=\"4\">\n A prior episode of CM, either as indicated by patient or as noted in patient medical records.</li>\n <li value=\"5\">\n Use of any of the following drugs, within the time periods described:</li>\n</ol>\n<ul>\n <li>\n any ARV within 30 days prior to study entry</li>\n <li>\n rifampin within 2 weeks prior to study entry, when enrollment is open to a cohort with an induction dose of fluconazole of 1200 mg daily (NOTE: this exclusion does not apply to participants who are enrolled at higher induction doses of fluconazole even if they have their individual dose reduced to 1200mg daily fluconazole based on their weight at study entry)</li>\n <li>\n warfarin within 3 days prior to study entry</li>\n <li>\n terfenadine or cisapride within 24 hours prior to study entry</li>\n <li>\n other drugs known to interact with fluconazole, the co-administration of which may lead to life-threatening side effects, within 10 days prior to study entry (see section 3 of the current A5225/HiFLAC MOPS)</li>\n <li>\n drugs that may decrease the effect of fluconazole, or whose co-administration may increase their own toxicity or decrease their own efficacy, within 24 hours prior to study entry (see section 3 of the current A5225/HiFLAC MOPS)</li>\n <li>\n phenytoin, carbamazepine, cyclosporin A, tacrolimus, sirolimus, astemizole, or long-acting barbiturates within 7 days prior to study entry</li>\n <li>\n more than 72 cumulative hours of systemic treatment with any antifungal for any reason within 14 days prior to study entry.</li>\n</ul>\n<ol>\n <li value=\"6\">\n Suspected or active tuberculosis (TB), even if untreated, for participants screening at the time that a 1200 mg daily fluconazole induction cohort is enrolling. A chest x-ray may be used to confirm suspected tuberculosis, but is not required.</li>\n <li value=\"7\">\n Known allergy, sensitivity to, or intolerance of fluconazole or other imidazole or triazole compounds, or to ampho B or other components of the standard of care ampho-B based regimen.</li>\n <li value=\"8\">\n History of clinically significant cardiac disease, in opinion of site investigator, including symptoms of ischemia, coronary artery disease, congestive heart failure, or arrhythmia.</li>\n <li value=\"9\">\n ECG (electrocardiogram) with QTc interval greater than 450 msec within 7 days prior to study entry.</li>\n <li value=\"10\">\n History of CNS disorder (excluding mood disorders) or concurrent CNS disorder(s) that, in the opinion of the investigator, would interfere with assessment of efficacy (e.g., ability to perform CSF sampling) such as lymphoma, neurocysticercosis, or toxoplasmosis.</li>\n <li value=\"11\">\n Receipt of investigational drug therapy within 30 days prior to study entry without prior approval of the A5225/HiFLAC core team.</li>\n <li value=\"12\">\n Receipt of any of the following for treatment of the current episode of CM:</li>\n</ol>\n<ul>\n <li>\n more than 1200 mg of fluconazole cumulative</li>\n <li>\n more than 1.5 mg/kg of ampho B cumulative</li>\n <li>\n more than 750 mg/kg of flucytosine cumulative</li>\n <li>\n more than 72 cumulative hours of any systemic antifungal therapy</li>\n</ul>\n<ol>\n <li value=\"13\">\n Active drug or alcohol use, dependence, or other conditions that in the opinion of the site investigator would jeopardize the safety of a participant in the study or would render the person unable to comply with the study plan.</li>\n</ol>\n<h3>\n Exclusion Criteria – Step 2</h3>\n<ol>\n <li>\n Receipt of fluconazole monotherapy in Step 1.</li>\n <li value=\"2\">\n Receipt of ≥8.4 mg/kg ampho B.</li>\n <li value=\"3\">\n At or beyond Day 17 in Step 1.</li>\n</ol>\n<h3>\n Exclusion Criteria – Step 3</h3>\n<ol>\n <li>\n On study treatment beyond week 10 (day 77) in Step 1 or Step 2.</li>\n <li value=\"2\">\n Currently off study treatment.</li>\n</ol>\n<h3>\n Exclusion Criterion – Step 4</h3>\n<ol>\n <li>\n Currently off study treatment</li>\n</ol>\n
      • primary_end_points
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers
      • other_details_explanation<p style=\"margin-left:36.0pt;\">\n The ultimate objective of this study is to determine whether an oral regimen (e.g., fluconazole alone) is acceptably potent and well tolerated for the treatment of HIV-associated CM.  A phase III clinical trial to compare the selected dose of fluconazole with a standard ampho B-based regimen would be of interest to providers where ampho B is available and should follow this study. In settings where use of an ampho B-based regimen is not feasible, fluconazole is often used at suboptimal doses. Establishing whether doses of fluconazole of 1200 mg or greater are tolerable and more effective than lower doses would be immediately applicable to patient care in these settings.</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n Moi University, Moi Teaching and Referral Hospital Institutional Research and Ethics committee. Granted continuing approval on 30th May 2013 for the Eldoret site.</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration48 weeks after enrolment of the last participant
      • 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_comparatorStandard of care i.e. amp
      • 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_states7 (seven)
      • number_of_sites2
      • multi_country_listKenya, India, Thailand, South Africa, Peru, Zimbabwe, U.S.A
      • data_monitoring_committeeYes
      • total_enrolment_per_siteUnknown
      • total_participants_worldwide192
      • 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_nameN/A
      • investigator1_middle_name
      • investigator1_family_nameN/A
      • investigator1_qualificationN/A
      • investigator1_professional_addressN/A
      • investigator1_telephoneN/A
      • investigator1_emailamsiika@africaonline.co.ke
      • organisations_transferred_No
      • number_participants30 at Eldoret site
      • notification
      • approval_date11-05-2012
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted07-06-2013
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n This study achieved its international accrual target of 168 participants at the end of 2016. Of these, 26 were from the MUCRC in Eldoret. Given the short 24 week follow up period, the last participant on study exited on January 31, 2017. Data analysis is currently ongoing and results will be sent to ECCT and disseminated to participants once they become available. All activities at the site for this study have been completed.</p>\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)
      • modified2018-12-07 10:52:47
      • created2013-06-04 11:44:11
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id88
        • application_id143
        • given_nameAbraham
        • middle_nameMosigisi
        • family_nameSiika
        • qualificationMBChB, MMed, MSc
        • professional_addressP O Box, 4606-30100, Eldoret
        • telephone0721280785
        • emailamsiika@africaonline.co.ke
        • created2013-06-04 12:34:53
        • modified2013-06-07 12:25:39
    • SiteDetail(array)
      • 0(array)
        • id110
        • application_id143
        • county_id27
        • site_nameMoi University Clinical Research Centre
        • physical_addressAMPATH at MTRH, Nandi Road, Eldoret
        • contact_detailsP O Box 4606 Eldoret
        • contact_personAllan Sudoi
        • site_capacity(null)
        • misc(null)
        • created2013-06-04 12:34:53
        • modified2013-06-07 12:25:39
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
    • Sponsor(array)
      • 0(array)
        • id69
        • application_id143
        • sponsorThe National Institute of Allergy and Infectious Diseases
        • sponsor_type(null)
        • contact_personUmesh G. Lalloo, MD, FRCP
        • addressNelson R. Mandela School of Medicine Private Bag 7 Congella Durban 4013
        • telephone_number27 31 260 4637
        • fax_number
        • cell_number27 31 260 4637
        • email_addresslalloo@nu.ac.za
        • created2013-06-04 12:34:53
        • modified2013-06-07 12:25:39
  • 1(array)
    • Application(array)
      • id142
      • user_id613
      • trial_status_id5
      • abstract_of_study<p>\n <font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\">The Human Immunodeficiency Virus (HIV) epidemic presents the most serious infectious </font></font></font><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\">disease threat worldwide. Despite effective preventative measures and improvements in Highly </font></font></font><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\">Active Anti-retroviral Therapy(HAART), the global pandemic of HIV remains out of control. HIV preventive vaccines are needed to contain this pandemic. RV 262 is a Phase I vaccine study of the safety and immunogenicity of two vaccine candidates; PENNVAX™-G DNA (env& gag) as prime followed by MVA-CMDR(HIV-1 CM235 env/ CM240 gag/pol) as boost in healthy, HIV-uninfected adult participants. The study will evaluate the safety and tolerability of these vaccine candidates and also their ability to induce HIV antigen specific cellular and humoral immune responses. The study also compares two DNA vaccine delivery methods, the Biojector® </font></font></font><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\">2000 needless and the CELLECTRA® intramuscular electroporation devices. The comparison will evaluate the method that yields the best immune response for PENNVAX™ -G. The MVA vaccine will be given by syringe and needle. A sub-study evaluating humoral mucosal immune response will also be done. RV 262 will be done in two parts, A and B. Part A is an open-label, safety and tolerability study to be conducted at one clinical site in Rockville USA. Part B is a randomized, placebo-controlled, double blind study to start after the product has been assessed as safe and tolerable in part A. The Kericho site will enroll 20 participants to Part B who will be randomized 4:1 to active study vaccine versus placebo. The study will last 15 months (3 months for screening; 12 months after enrollment) per study participant for the active study phase and an additional 18 months passive follow up for all study participants. This study will provide new, preliminary data regarding the safety and immunogenicity of PENNVAX™-G DNA followed by MVA-CMDR using a prime/boost strategy. Combined, this DNA prime-MVA boost strategy </font></font></font><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\">may enhance immunogenicity without compromising safety.</font></font></font></p>\n
      • study_title<p>\n <font color=\"#010202\"><font face=\"Times New Roman\"><font size=\"3\">A Phase I Study of the Safety and Immunogenicity of PENNVAX™-G <font lang=\"KO\"><font lang=\"KO\"><font lang=\"KO\">DNA (Env & Gag) Administered by Intramuscular Biojector</font></font></font></font>^{<font lang=\"KO\" size=\"1\"><font lang=\"KO\" size=\"1\"><font lang=\"KO\" size=\"1\">® </font></font></font>}<font lang=\"KO\" size=\"3\"><font lang=\"KO\" size=\"3\"><font lang=\"KO\" size=\"3\">2000 or by </font></font></font><font lang=\"KO\" size=\"3\"><font lang=\"KO\" size=\"3\"><font lang=\"KO\" size=\"3\">CELLECTRA</font></font></font>^{<font lang=\"KO\" size=\"1\"><font lang=\"KO\" size=\"1\"><font lang=\"KO\" size=\"1\">® </font></font></font>}<font lang=\"KO\" size=\"3\"><font lang=\"KO\" size=\"3\"><font lang=\"KO\" size=\"3\">Intramuscular Electroporation Device Followed by MVACMDR </font></font></font><font lang=\"KO\" size=\"3\"><font lang=\"KO\" size=\"3\"><font lang=\"KO\" size=\"3\">(HIV-1 CM235 env/ CM240 gag/pol) Boost in Healthy, HIV </font></font></font><font lang=\"KO\" size=\"3\"><font lang=\"KO\" size=\"3\"><font lang=\"KO\" size=\"3\">Uninfected Adults</font></font></font></font></font></p>\n
      • laymans_summary<p>\n <font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\">The Human Immunodeficiency Virus (HIV) epidemic presents the most serious infectious </font></font></font><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\">disease threat worldwide. Despite effective preventative measures and improvements in Highly </font></font></font><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\">Active Anti-retroviral Therapy(HAART), the global pandemic of HIV remains out of control. HIV preventive vaccines are needed to contain this pandemic. RV 262 is a Phase I vaccine study of the safety and immunogenicity of two vaccine candidates; PENNVAX™-G DNA (env& gag) as prime followed by MVA-CMDR(HIV-1 CM235 env/ CM240 gag/pol) as boost in healthy, HIV-uninfected adult participants. The study will evaluate the safety and tolerability of these vaccine candidates and also their ability to induce HIV antigen specific cellular and humoral immune responses. The study also compares two DNA vaccine delivery methods, the Biojector® </font></font></font><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\">2000 needless and the CELLECTRA® intramuscular electroporation devices. The comparison will evaluate the method that yields the best immune response for PENNVAX™ -G. The MVA vaccine will be given by syringe and needle. A sub-study evaluating humoral mucosal immune response will also be done. RV 262 will be done in two parts, A and B. Part A is an open-label, safety and tolerability study to be conducted at one clinical site in Rockville USA. Part B is a randomized, placebo-controlled, double blind study to start after the product has been assessed as safe and tolerable in part A. The Kericho site will enroll 20 participants to Part B who will be randomized 4:1 to active study vaccine versus placebo. The study will last 15 months (3 months for screening; 12 months after enrollment) per study participant for the active study phase and an additional 18 months passive follow up for all study participants. This study will provide new, preliminary data regarding the safety and immunogenicity of PENNVAX™-G DNA followed by MVA-CMDR using a prime/boost strategy. Combined, this DNA prime-MVA boost strategy </font></font></font><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\">may enhance immunogenicity without compromising safety.</font></font></font></p>\n
      • short_titlePENNVAX-G DNA/MVA HIV Vaccine Phase 1 trial
      • protocol_noECCT/11/12/04
      • version_no2.0
      • date_of_protocol20-01-2011
      • study_drugPENNVAX™-G DNA (HIV-1 env A,C and D, and consensus gag plasmids), MVA-CMDR Live attenuated Modified Vaccinia Ankara vector expressing HIV-1 CM235 env/ CM240 gag/pol, Placebo (Control)—Sodium Chloride Injection USP, 0.9%
      • disease_conditionHIV/AIDS
      • 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
      • comparatorYes
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjoel.chebon@usamru-k.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_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd0
      • applicant_prev_data0
      • applicant_stability_data0
      • applicant_analysis_cert0
      • applicant_pictorial_sample0
      • applicant_gcp_training0
      • applicant_dsmb_charter0
      • applicant_detailed_budget0
      • applicant_indemnity_pi1
      • applicant_practice_license0
      • applicant_registration_ctr(null)
      • applicant_pan_african0
      • applicant_hard_copies(null)
      • applicant_signed_checklist0
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantJosephat Kosgei
      • declaration_date105-06-2013
      • declaration_principal_investigatorFredrick Kipyego Sawe
      • declaration_date205-06-2013
      • placebo_presentYes
      • study_objectives<div>\n PRIMARY OBJECTIVE</div>\n<div>\n § To evaluate the safety and tolerability of PENNVAX™-G DNA (env& gag)</div>\n<div>\n administered by IM Biojector® 2000 or IM CELLECTRA® electroporation followed</div>\n<div>\n by IM MVA-CMDR (HIV-1 CM235 env/ CM240 gag/pol) boost in healthy HIVuninfected</div>\n<div>\n adult participants.</div>\n<div>\n 3.2 SECONDARY OBJECTIVE</div>\n<div>\n § To evaluate the ability of PENNVAX™-G DNA (env& gag) and MVA-CMDR</div>\n<div>\n (HIV-1 CM235 env/ CM240 gag/pol) in a DNA/MVA prime/boost strategy to induce</div>\n<div>\n HIV antigen specific cellular and humoral immune responses.</div>\n<div>\n 3.2.1 MUCOSAL SUBSTUDY OBJECTIVES</div>\n<div>\n § Evaluate the acceptability, feasibility, and quality of mucosal collection using the</div>\n<div>\n Instead Softcup method.</div>\n<div>\n § Characterize the humoral responses in the mucosal compartments in the vaccine and</div>\n<div>\n placebo recipients.</div>\n<div>\n § Characterize the humoral response in the mucosal compartment in volunteers</div>\n<div>\n receiving DNA alone versus MVA boost.</div>\n<div>\n § Characterize the humoral responses in the mucosal compartments in volunteers</div>\n<div>\n receiving DNA by Biojector or EP.</div>\n
      • principal_inclusion_criteria<ol>\n <li>\n <span style=\"font-family: arial,helvetica,sans-serif;\"><span style=\"font-size: 16px;\"><span lang=\"EN-GB\" style=\"color: black;\">HIV un-infected, healthy adults</span></span></span></li>\n <li>\n <span style=\"font-family: arial,helvetica,sans-serif;\"><span style=\"font-size: 16px;\"><span lang=\"EN-GB\" style=\"color: black;\">18-49 years at the time of enrolment</span></span></span></li>\n <li>\n <span style=\"font-family: arial,helvetica,sans-serif;\"><span style=\"font-size: 16px;\"><span lang=\"EN-GB\" style=\"color: black;\">Low risk for HIV infection</span></span></span></li>\n <li>\n <span style=\"font-family: arial,helvetica,sans-serif;\"><span style=\"font-size: 16px;\"><span lang=\"EN-GB\" style=\"color: black;\">Availability and willingness to participate for the duration of the study</span></span></span></li>\n</ol>\n
      • principal_exclusion_criteria<ol>\n <li>\n <span style=\"font-size: 16px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><span lang=\"EN-GB\"><font color=\"#000000\">HIV infection</font></span></span></span></li>\n <li>\n <span style=\"font-size: 16px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><span lang=\"EN-GB\"><font color=\"#000000\">A woman who is pregnant, planning on becoming pregnant or breastfeeding</font></span></span></span></li>\n <li>\n <span style=\"font-size: 16px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><span lang=\"EN-GB\"><font color=\"#000000\">High risk for HIV infection</font></span></span></span></li>\n <li>\n <span style=\"font-size: 16px;\"><span style=\"font-family: arial,helvetica,sans-serif;\">Any clinically significant medical condition that in the opinion of the investigator would    preclude participation</span></span></li>\n <li>\n <span style=\"font-size: 16px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><span lang=\"EN-GB\"><font color=\"#000000\">History of anaphylaxis or other serious adverse reactions to vaccines or egg products</font></span></span></span></li>\n <li>\n <span style=\"font-size: 16px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><span lang=\"EN-GB\"><font color=\"#000000\">Recipient of HIV vaccine candidate at any time</font></span></span></span></li>\n</ol>\n
      • primary_end_points<p>\n <span style=\"font-family: arial,helvetica,sans-serif;\"><span style=\"font-size: 12px;\"><strong><u>Safety</u></strong></span></span></p>\n<p>\n <span style=\"font-family: arial,helvetica,sans-serif;\"><span style=\"font-size: 12px;\">Safety assessments will be made throughout the trial to evaluate local toxicity (reactogenicity) and systemic reactions (adverse events) by means of clinical evaluation and clinical tests: hematology, blood chemistry and urinalysis. Safety endpoints will include severe local toxicity at injection site and severe systemic symptoms judged to be probably or definitely related to the vaccine.</span></span></p>\n<p>\n <u><span style=\"font-family: arial,helvetica,sans-serif;\"><span style=\"font-size: 12px;\"><strong><font color=\"#010202\"><font color=\"#010202\"><font color=\"#010202\">Immunogenicity</font></font></font></strong></span></span></u></p>\n<p align=\"LEFT\">\n <span style=\"font-family: arial,helvetica,sans-serif;\"><span style=\"font-size: 12px;\"><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\">The study is descriptive and exploratory in nature and is not powered to detect significant differences in cell-mediated or humoral immune responses. Immunogenicity responses will be </font></font></font><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\">measured in placebo recipients but will not be compared to responses among vaccine recipients. </font></font></font><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\">For all assays, specificity will be assessed by defining the false positive rates using all baseline </font></font></font><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\">(pre-vaccination) and placebo samples in aggregate. For the analysis of immunogenicity, groups </font></font></font><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\">I and III (Biojector</font></font></font><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\">® </font></font></font><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\">groups) will be combined and groups II and IV (Electroporation groups) </font></font></font><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\">will be combined. For each assay, response rates and response magnitude (as appropriate) will be </font></font></font><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\">described for the Biojector </font></font></font><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\">groups and Electroporation groups for the vaccine recipients and placebo recipients separately.</font></font></font></span></span></p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyImmunogenicity
      • trial_human_pharmacology1
      • trial_administration_humans1
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n As indicated on the attached Site Specific Addendum.</p>\n
      • other_details_explanation<p>\n The trial is being conducted both in Kenya and Host country.</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n <span lang=\"EN-GB\" style=\"font-family: ;\"><strong><font color=\"#000000\">Walter Reed Army Institute of Research IRB Approval with stipulations on 13 April 2011</font></strong></span>,</p>\n<p>\n <span lang=\"EN-GB\" style=\"font-family: ;\"><strong><font color=\"#000000\">KEMRI ERC</font></strong></span> -<strong> <span style=\"font-size: 16px;\">03 JAN 2013</span></strong></p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_durationThe active phase of the study will last 15 months followed by 18 months of passive follow-up.
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI/Walter Reed Project-Kericho
      • single_site_physical_addressClinical Research Center, Off Hospital Road, Kericho.
      • single_site_contact_personFred SAWE
      • single_site_telephone052 30686
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states4
      • number_of_sites
      • multi_country_listKenya, Uganda, Tanzania, United States of America
      • data_monitoring_committeeYes
      • total_enrolment_per_site20
      • total_participants_worldwide92
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameN/A
      • investigator1_middle_name
      • investigator1_family_nameN/A
      • investigator1_qualificationN/A
      • investigator1_professional_addressN/A
      • investigator1_telephoneN/A
      • investigator1_emailfsawe@hivresearch.org
      • organisations_transferred_Yes
      • number_participants20
      • notification<p>\n THe trial has been previously approved and is being uploaded at the request of ECCT secretariat for purposes of updating the trials database.</p>\n<p>\n  </p>\n
      • approval_date15-02-2013
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted17-07-2020
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n The HIV vaccine study completed enrollment, follow-up and all study participants exited the study. The primary analysis is complete and findings published.</p>\n<p>\n  </p>\n<p>\n Executive Summary as uploaded under notifications.</p>\n
      • implication_results<p>\n Publications uploaded. The results of the study importatant in the continued efforts in HIV vaccine development.</p>\n
      • quantity_imported30
      • quantity_dispensed22
      • quantity_destroyed8
      • quantity_exported0
      • balance_site0
      • final_date0000-00-00
      • modified2020-09-11 13:05:02
      • created2013-06-04 09:56:15
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id87
        • application_id142
        • given_nameFREDRICK
        • middle_nameKIPYEGO
        • family_nameSAWE
        • qualificationMBChB, MMED
        • professional_addressP.O Box 1357, 20200, Kericho, Kenya
        • telephone(254-52) 30686,30388
        • emailfsawe@wrp-kch.org
        • created2013-06-04 12:00:11
        • modified2020-07-17 09:39:08
    • SiteDetail(array)
      • 0(array)
        • id109
        • application_id142
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2013-06-04 12:00:11
        • modified2020-07-17 09:39:08
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id68
        • application_id142
        • sponsorDivision of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases US National Institute of Health
        • sponsor_typeOthers
        • contact_person
        • address6700 B Rockledge Drive, Bethesda, MD 20817
        • telephone_number+301-435-3734
        • fax_number+301-402-1506
        • cell_number+301-435-3734
        • email_addressviseth.ngauy@us.army.mil
        • created2013-06-04 12:00:11
        • modified2020-07-17 09:39:08
  • 2(array)
    • Application(array)
      • id133
      • user_id40
      • trial_status_id5
      • abstract_of_study<p>\n <strong>Background: </strong>The development of an effective, accessible vaccine is the only realistic hope for halting the human immunodeficiency virus type 1 epidemic. Ideally, such a vaccine should induce broadly neutralizing antibodies and effective T cells at the same time; however, both of these goals face substantial and very different challenges. A rational scientific strategy tackles and solves these roadblocks separately before combining the two successful solutions into a single vaccine formulation. This study focuses on induction of effective T cells.</p>\n<p>\n <strong>Method:</strong> We propose to conduct a Phase 1/IIa randomized, placebo-controlled, double-blind clinical trial in HIV-uninfected healthy adult volunteers at low-risk for HIV infection to evaluate the safety, tolerability and immunogenicity of the three vaccines pSG2.HIVconsv DNA (D), ChAdV63.HIVconsv (C) and MVA.HIVconsv (M) in Kenya using CM and DDDCM regimens.</p>\n<p>\n <strong>Primary Objectives</strong></p>\n<ul>\n <li>\n To evaluate the safety of the pSG2.HIVconsv DNA, ChAdV63.HIVconsv and MVA.HIVconsv vaccines administered sequentially by intramuscular needle injection in heterologous prime-boost regimens into healthy, low-risk, HIV-1-uninfected adult volunteers.</li>\n</ul>\n<p>\n <strong>Secondary Objectives</strong></p>\n<ul>\n <li>\n To evaluate the immunogenicity of the pSG2.HIVconsv DNA, ChAdV63.HIVconsv and MVA.HIVconsv vaccines administered sequentially by intramuscular needle injection in two different heterologous prime-boost regimens into healthy, low-risk, HIV-1-uninfected adult volunteers.</li>\n <li>\n To compare the immunogenicity (breadth, specificity and HIV-1 clade coverage of T cell responses) of two regimens DDDCM and CM.</li>\n <li>\n To determine whether priming with three DNA vaccinations (DDDCM regimen) affects the frequency, durability and/or quality of T cell responses to the HIVconsv immunogen by comparing responses to the DDDCM and CM regimens.</li>\n</ul>\n<p>\n  </p>\n<p>\n <strong>Study Population:</strong> The study population consists of healthy male or female adults aged 18-50 years at low risk for HIV infection, who are willing to undergo HIV testing, use an effective method of contraception, and who in the opinion of the investigator or designee, understand the study and provide written informed consent. Approximately 48 volunteers (40 vaccine recipients, 8 placebo recipients) who meet all eligibility criteria will be included in the study.</p>\n
      • study_title<p>\n A phase I/IIa clinical trial of universal HIV-1 vaccines pSG2.HIVconsv DNA, MVA.HIVconsv and ChAdV63.HIVconsv in combined regimens in healthy HIV-1/2-negative adults in Nairobi.</p>\n
      • laymans_summary(null)
      • short_titleHIVCORE004/N004
      • protocol_noECCT/13/07/01
      • version_no2.3
      • date_of_protocol15-04-2013
      • study_drugpSG2.HIVconsv DNA; non-replicating chimp adenovirus ChAdV63.HIVconsv; non-replicating poxvirus MVA.HIVconsv.
      • disease_conditionHIV vaccine development
      • 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
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressgmutua@kaviuon.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_applicantDr. Gaudensia Nzembi Mutua
      • declaration_date105-07-2013
      • declaration_principal_investigatorProf. Walter Jaoko
      • declaration_date205-07-2013
      • placebo_presentYes
      • study_objectives(null)
      • principal_inclusion_criteria<ol>\n <li>\n Healthy male or female, as assessed by a medical history, physical exam, and laboratory tests</li>\n <li>\n <p>\n At least 18 years of age on the day of screening and has not reached his/her 51st birthday on the day of first vaccination</p>\n </li>\n <li>\n <p>\n If sexually active female; using an effective method of contraception (e.g. hormonal contraception, diaphragm, intra-uterine device (IUD), condoms, anatomical sterility in self or partner) from 14 days prior to the first vaccination until at least 6 weeks after the last vaccination</p>\n </li>\n <li>\n <p>\n Assessed by the clinic staff as being at “low risk” for HIV infection on the basis of self-reported sexual behaviour within the 6 months prior to enrolment</p>\n </li>\n <li>\n <p>\n Willing to forgo donations of blood during the study.</p>\n </li>\n</ol>\n
      • principal_exclusion_criteria<ol>\n <li>\n Confirmed HIV-1 or HIV-2 infection</li>\n <li>\n Any clinically significant acute or chronic medical condition that is considered progressive, or in the opinion of the investigator, makes the volunteer unsuitable for participation in the study</li>\n <li>\n If female, pregnant or planning a pregnancy within 6weeks after the last study vaccination; or lactating</li>\n <li>\n Smallpox vaccination within the previous 3 years (smallpox vaccination more than 3 years before enrolment should be documented but is not an exclusion criterion).</li>\n</ol>\n
      • primary_end_points<p>\n The safety of the vaccines will be determined by analysis of local and systemic reactogenicity, and biochemical and haematological data.</p>\n<p>\n The data will be expressed as</p>\n<p>\n •           Proportion of volunteers who develop a grade 3 or 4 local reaction.</p>\n<p>\n •           Proportion of volunteers who develop a grade 3 or 4 systemic reaction.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyImmunogenicity
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n The study will be conducted at the KAVI-Kangemi site which is community based in a slum area within the environs of Nairobi and is located within the premises of a government sponsored Kangemi health centre. Accessibility is good by public transport and it is a 30-45min drive away from the main KAVI-KNH site. KAVI-KNH site is located off Ngong road within the premises of the Kenyatta National Referral hospital and covers two floors in the department of Medical Microbiology of the University of Nairobi. The site facilities are largely comprised of re-furbished shipping containers. It has a pharmacy that is under 24hour automated temperature control and is supported by a 27KVA generator. It has a small laboratory for sample collection and initial sample processing but the main laboratory is located in the KAVI-KNH study site. The site has emergency facilities with a portable defibrillator to manage any acute medical conditions that may arise during the conduct of the clinical trial. KAVI-KNH forms the administrative centre for the two sites. Each site holds weekly meetings to discuss ongoing studies and both sites hold a joint meeting at KAVI-KNH every two weeks. The key staff are listed below:</p>\n<p>\n <strong>Prof. Walter Jaoko;  MBCHB PHD</strong></p>\n<p>\n Principal Investigator</p>\n<p>\n Department of Medical Microbiology -University of Nairobi</p>\n<p>\n PO Box 19676 Nairobi, Kenya</p>\n<p>\n Tel: +254 727555254</p>\n<p>\n Fax: +254 (0) 022714613</p>\n<p>\n Email: <span style=\"text-decoration: underline;\">wjaoko@kaviuon.org</span></p>\n<p>\n  </p>\n<p>\n <strong>Gaudensia Mutua MBChB, MPH</strong></p>\n<p>\n Sub-Investigator</p>\n<p>\n Department of Med. Microbiology (UON)</p>\n<p>\n Tel: +254733826815</p>\n<p>\n Email: <a href=\"mailto:gmutua@kaviuon.org\">gmutua@kaviuon.org</a></p>\n<p>\n <strong>Kefa Ogonyo Bosire (B.Pharm, M.Pharm(UoN), MSc (London)</strong></p>\n<p>\n Consultant Pharmacist</p>\n<p>\n Dept. Pharmacology (School of Pharmacy)</p>\n<p>\n University of Nairobi</p>\n<p>\n Tel: +254733241332 or +254713542111</p>\n<p>\n                                    </p>\n<p>\n <strong>Jacqueline Rita Nyange KRN, BA, MSc.    </strong></p>\n<p>\n Clinical Trials Coordinator/Regulatory Compliance Officer</p>\n<p>\n Dept. Med. Microbiology- UON</p>\n<p>\n Tel: +254722899532</p>\n<p>\n Email: <a href=\"mailto:jrnyange@kaviuon.org\">jrnyange@kaviuon.org</a></p>\n<p>\n  </p>\n<p>\n <strong>Rose Sajabi KRN/M/PH, BSc Psychology</strong></p>\n<p>\n Study Coordinator/Nurse Counsellor</p>\n<p>\n Dept Med. Microbiology- UON</p>\n<p>\n Tel: +254722259866</p>\n<p>\n Email: <a href=\"mailto:rsajabi@kaviuon.org\">rsajabi@kaviuon.org</a></p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <strong>Bashir Farah MSc</strong></p>\n<p>\n Laboratory Manager</p>\n<p>\n Dept. Med. Microbiology- UON</p>\n<p>\n Tel: +254722566945</p>\n<p>\n Email: <a href=\"mailto:fbashir@kaviuon.org\">fbashir@kaviuon.org</a></p>\n
      • other_details_explanation<p>\n The study products in this study have been used in other studies in the host country (UK)</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<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_durationVolunteers will be screened up to 28 days before the 1st vaccination. This study will last 19 months (from screening of first volunteer to 5 months after last immunisation of last volunteer, assuming approximately 2 recruits per week)
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo reciepients will
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKAVI-KANGEMI RESEARCH SITE
      • single_site_physical_addressKANGEMI HEALTH CENTRE
      • single_site_contact_personDR GAUDENSIA MUTUA
      • single_site_telephone+254733826815
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site48 (Only one site involved in this study)
      • total_participants_worldwide48
      • 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_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameNot Applicable
      • investigator1_middle_name
      • investigator1_family_nameNA
      • investigator1_qualificationNA
      • investigator1_professional_addressNA
      • investigator1_telephoneNA
      • investigator1_emailwjaoko@kaviuon.org
      • organisations_transferred_Yes
      • number_participants48
      • notification
      • approval_date19-06-2013
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted05-07-2013
      • 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)
      • modified2016-03-03 13:02:40
      • created2013-05-21 15:06:07
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id82
        • application_id133
        • given_nameProf. Walter
        • middle_nameGodfrey
        • family_nameJaoko
        • qualificationMBChB PhD
        • professional_addressKAVI- Institute of Clinical Research, University of Nairobi PO Box 19676-00202 Nairobi Kenya
        • telephone+254 727555254
        • emailwjaoko@kaviuon.org
        • created2013-05-21 15:15:31
        • modified2013-07-05 13:19:16
    • SiteDetail(array)
      • 0(array)
        • id102
        • application_id133
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2013-05-21 15:15:31
        • modified2013-07-05 13:19:16
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id63
        • application_id133
        • sponsorUniversity of Oxford
        • sponsor_type(null)
        • contact_personProfessor Tomáš Hanke
        • addressUniversity of Oxford, Joint Research Office, Block 60, Churchill Hospital, Oxford OX3 7LE UK
        • telephone_number+44 (0)1865 617630
        • fax_number+44 (0)1865 630608
        • cell_number+44 (0)1865 617630
        • email_addresstomas.hanke@ndm.ox.ac.uk
        • created2013-05-21 15:15:31
        • modified2013-07-05 13:19:16
  • 3(array)
    • Application(array)
      • id93
      • user_id21
      • trial_status_id5
      • abstract_of_study<p style=\"margin-left: 40px;\">\n <u>DESIGN</u>                      A5297 is a phase I/II, open-label, proof of concept, two-step, two-arm, controlled randomized clinical trial (RCT) to test the superiority of lopinavir/ritonavir (LPV/r)-based antiretroviral therapy (ART) to non-nucleoside reverse transcriptase (nNRTI)-based ART for clearance of <em>Plasmodium falciparum (Pf)</em> subclinical parasitemia (SCP). </p>\n<p style=\"margin-left: 40px;\">\n  </p>\n<p style=\"margin-left: 40px;\">\n Participants will be followed for 30 days in order to evaluate parasitemia clearance, <em>Pf</em> parasitemia, gametocytemia, and plasmepsin sequencing.  Participants will have blood collected twice at entry, day 3, 6, 9, 12, 20, and 25 and three times for day 15 and day 30. Therefore, on most study days, participants will need to either remain at the clinic for an extended period of time or be willing to return two or three times at approximately 8-hour intervals (see section 6.2 for details).</p>\n<p style=\"margin-left: 40px;\">\n  </p>\n<p style=\"margin-left: 40px;\">\n <u>DURATION</u>                30 days:  Step 1= days 1-15; Step 2= days 16-30</p>\n<p style=\"margin-left: 40px;\">\n                                    </p>\n<p style=\"margin-left: 40px;\">\n <u>SAMPLE SIZE</u>            52 participants</p>\n<p style=\"margin-left: 40px;\">\n  </p>\n<p style=\"margin-left: 40px;\">\n <u>POPULATION</u>            HIV infected adults at least 18 years of age with CD4+ counts >200 and <u><</u> 350 cells/mm³ who will be starting ART and have <em>Pf</em> SCP.  Individuals with signs or symptoms suggestive of concurrent opportunistic infections, pulmonary or gastrointestinal infections, or clinical malaria will be excluded.</p>\n<p style=\"margin-left: 40px;\">\n  </p>\n<p style=\"margin-left: 40px;\">\n <u>REGIMENS</u>                <u>Step 1</u></p>\n<p style=\"margin-left: 40px;\">\n Participants will be randomized 1:1 to one of the following arms for 15 days: </p>\n<p>\n                                     Arm A: LPV/r-based ART</p>\n<p style=\"margin-left: 40px;\">\n Arm B: nNRTI-based ART</p>\n<p style=\"margin-left: 40px;\">\n  </p>\n<p style=\"margin-left: 40px;\">\n <u>Step 2</u></p>\n<p style=\"margin-left: 40px;\">\n All participants will receive an nNRTI-based ART and TMP/SMX prophylaxis to take from day 16 through day 30.</p>\n
      • study_title<p>\n A5297: An Open-Label, Proof of Concept, Randomized Trial Comparing a LPV/r-Based to an nNRTI-Based Antiretroviral Therapy Regimen for Clearance of</p>\n<p>\n <em>Plasmodium falciparum</em> Subclinical Parasitemia in HIV-infected Adults with CD4+ Counts >200 and <u><</u>350 cells/mm³</p>\n
      • laymans_summary(null)
      • short_titleNot provided
      • protocol_noECCT/12/11/02
      • version_no1.0
      • date_of_protocol29-02-2012
      • study_drugLopinavir/ritonavir (LPV/r)
      • disease_conditionPlasmodium falciparum (Pf) subclinical parasitemia (SCP).
      • 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_nameAluvia
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressaksudoi@hotmail.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_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_applicantAllan K Sudoi
      • declaration_date105-04-2013
      • declaration_principal_investigatorAbraham M Siika, MBChB, MMed, Msc - Site Principal Investigator
      • declaration_date205-04-2013
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria
      • principal_exclusion_criteria
      • primary_end_points
      • scope_diagnosis1
      • scope_prophylaxis1
      • scope_therapy1
      • 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_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers
      • other_details_explanation<p>\n Eldoret Kenya is one of the international ACTG sites. The subject under study (malaria) is not prevalent in the USA. The study will therefore be carried out in countries where malaria is endemic.</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n Moi Teaching and Referral Hospital/Moi University Institutional Research and Ethics Committee (IREC). Approved on 10 September 2012 for Eldoret site only</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_durationAll participants will be followed for 30 days after randomization.
      • 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_comparatornNRTI-based ART
      • 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(null)
      • single_site_contact_person(null)
      • single_site_telephone(null)
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states4
      • number_of_sites2
      • multi_country_listKenya, Malawi, Uganda and India
      • data_monitoring_committeeYes
      • total_enrolment_per_site20 participants at the Eldoret Site
      • total_participants_worldwide52 Participants
      • 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_nameN/A
      • investigator1_middle_name
      • investigator1_family_nameN/A
      • investigator1_qualificationN/A
      • investigator1_professional_addressN/A
      • investigator1_telephone(null)
      • investigator1_email(null)
      • organisations_transferred_No
      • number_participants35 Participants
      • notification
      • approval_date29-02-2012
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted05-04-2013
      • 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)
      • modified2018-03-26 12:25:24
      • created2013-04-04 15:53:20
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id61
        • application_id93
        • given_nameAbraham
        • middle_nameMosigisi
        • family_nameSiika
        • qualificationMBChB, MMed, MSc
        • professional_addressP O Box, 4606-30100, Eldoret
        • telephone(null)
        • email(null)
        • created2013-04-04 16:21:33
        • modified2013-04-05 12:10:55
    • SiteDetail(array)
      • 0(array)
        • id82
        • application_id93
        • county_id27
        • site_nameMoi University Clinical Research Centre
        • physical_addressAMPATH at MTRH, Nandi Road, Eldoret
        • contact_details+254 53 2060850
        • contact_personAllan Sudoi
        • site_capacity(null)
        • misc(null)
        • created2013-04-04 16:21:33
        • modified2013-04-05 12:10:55
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
    • Sponsor(array)
      • 0(array)
        • id47
        • application_id93
        • sponsorNational Institutes of Health
        • sponsor_type(null)
        • contact_person
        • address9000 Rockville Pike Bethesda, Maryland 20892
        • telephone_number301-496-4000
        • fax_number
        • cell_number301-496-4000
        • email_addressNIHinfo@od.nih.gov
        • created2013-04-04 16:21:33
        • modified2013-04-05 12:10:55
  • 4(array)
    • Application(array)
      • id92
      • user_id613
      • trial_status_id7
      • abstract_of_study<p>\n Areas of high HIV prevalence and intense malaria transmission significantly overlap especially sub-Saharan Africa where a majority of HIV-infected individuals also live in malaria-endemic regions.  Sub-Saharan Africa remains the region most heavily affected by HIV, accounting for 67% of all people living with HIV and 75% of AIDS deaths in 2007.  Each year 350–500 million cases of malaria occur worldwide, and over one million people die, most of them young children, in sub-Saharan Africa.                                           </p>\n<p>\n Recent studies have indicated that the interaction between HIV and malaria infection is bi-directional and synergistic. HIV-infected persons are at increased risk for clinical malaria and potential malaria treatment failure. In addition to an apparent increased vulnerability to malaria parasitemia in HIV-infected adults living in malaria endemic regions, malaria may also enhance HIV replication.  Evidence suggests that HIV/malaria coinfection is associated with increased HIV viral load and may therefore impact negatively upon HIV disease progression and/or increase the risk of HIV transmission.  In Kenya, the burden of both HIV and malaria remains significant.  However, while clinic programs and research studies are ongoing targeting HIV and malaria separately, very little if any research is ongoing focusing upon the HIV/malaria co-infection.</p>\n<p>\n Methods used to prevent the spread of malaria disease endemic areas include prophylactic drugs, mosquito eradication, and the prevention of mosquito bites. Attention to non-traditional malaria therapies that may have antimalarial effects is ongoing given the magnitude of malaria related morbidity and mortality.  Identifying drugs, such as PIs used in the treatment of HIV/AIDS (which are becoming more available in sub-Saharan Africa), with antimalarial activity will provide additional tools in comprehensive malaria control and prevention programs.</p>\n<p>\n This study will test the superiority of LPV/r-based ART compared with nNRTI-based ART clearance of <em>Pf</em> SCP.  The primary endpoint is PCR defined clearance of <em>Pf</em> parasitemia on three consecutive occasions within a 24-hour period. HIV-infected participants ≥18 years with CD4+ counts >200 and <u><</u>350 cells/mm³ who will be starting ART and have <em>Pf</em> SCP will be enrolled and randomized to receive either LPV/r or nNRTI-based ART for 15 days. After the 15 day <em>Pf</em> SCP clearance evaluation, all participants will receive nNRTI-based ART plus TMP/SMX prophylaxis to take for 15 days.</p>\n<p>\n The Kericho site will recruit about 20-30 participants, in part dependent upon timing of protocol activation compared to the other 5 sites in this international, multi-center study.  Recruitment will be focused at the Kericho District Hospital HIV clinic.  Nearby health and HIV Testing and Counseling (HTC) facilities under the KEMRI/WRP PEPFAR program will also be utilized.  Participants will be followed for 30 days. The site accrual rate is estimated to be 2-3 participants per month; hence estimated duration of accrual is about 12 months.</p>\n<p>\n  </p>\n<p>\n If PIs are shown to have marked benefit in clearance of subclinical malaria, such information would be informative to both clinical researchers (i.e. KEMRI) in considering future HIV/malaria infection research as well as policy stakeholders (i.e. Ministry of Health) in considering optimal treatment and prevention initiatives.</p>\n
      • study_title<p align=\"center\">\n  </p>\n<p style=\"text-align: justify;\">\n <strong>An Open-Label, Proof of Concept, Randomized Trial Comparing a LPV/r-Based to an nNRTI-Based Antiretroviral Therapy Regimen for Clearance of </strong></p>\n<p style=\"text-align: justify;\">\n <strong><em>Plasmodium falciparum</em></strong><strong> Subclinical Parasitemia in HIV-infected Adults with CD4+ Counts >200 and <u><</u>350 cells/mm³</strong> .</p>\n
      • laymans_summary<p>\n The areas that has highest problems of HIV infection, also experiences the biggest burden of malaria. Sub-Saharan Africa remains the region most heavily affected by HIV.  Each year 350–500 million cases of malaria occur worldwide, and over one million people die, most of them young children, in sub-Saharan Africa. Methods used to prevent the spread of malaria disease endemic areas include prophylactic drugs, mosquito eradication, and the prevention of mosquito bites. Attention to non-traditional malaria therapies that may have antimalarial effects is ongoing given the magnitude of malaria related morbidity and mortality.  Identifying drugs, such as those used in the treatment of HIV/AIDS (which are becoming more available in sub-Saharan Africa), with antimalarial activity will provide additional tools in comprehensive malaria control and prevention programs</p>\n
      • short_titleHIV-Malaria Study_A5297
      • protocol_noECCT/13/04/03
      • version_noVersion 1.0
      • date_of_protocol29-02-2012
      • study_drugefavirenz (EFV), nevirapine (NVP), emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), lopinavir/ritonavir (LPV/r), and trimethoprim/sulfamethoxazole (TMP/SMX) DS.
      • disease_conditionHIV and Malaria
      • 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_nameefavirenz (EFV), nevirapine (NVP), emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), lopinavir/ritonavir (LPV/r), and trimethoprim/sulfamethoxazole (TMP/SMX) DS.
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjosphat.kosgei@usamru-k.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_countries0
      • 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_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantKEMRI Walter Reed Project. P.O. Box 1357-20200 Kericho
      • declaration_date108-04-2013
      • declaration_principal_investigatorDr Josphat Kiprop Kosgei, Principal Investigator.
      • declaration_date208-04-2013
      • placebo_presentNo
      • study_objectives<div>\n Primary Objective</div>\n<div>\n To compare the proportions of Pf SCP clearance between LPV/r-based and</div>\n<div>\n nNRTI based ART in participants after 15 days of therapy (Step 1).</div>\n<div>\n 1.4 Secondary Objectives</div>\n<div>\n 1.4.1 To compare time to Pf SCP clearance in participants with Pf SCP who have</div>\n<div>\n received 15 days of LPV/r-based and nNRTI-based ART.</div>\n<div>\n 1.4.2 To compare Pf parasite densities in participants with Pf SCP who have received</div>\n<div>\n 15 days of LPV/r-based and nNRTI-based ART.</div>\n<div>\n 1.4.3 To estimate changes in Pf parasite densities from day 1 to day 30 in four cohorts:</div>\n<div>\n (1) randomized to nNRTI-based ART with continued Pf SCP at day 15, (2)</div>\n<div>\n randomized to nNRTI-based ART with clearance of Pf SCP at day 15, (3)</div>\n
      • principal_inclusion_criteria<p style=\"margin-left: 1in;\">\n HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.</p>\n<p style=\"margin-left: 1in;\">\n  </p>\n<p style=\"margin-left: 1in;\">\n Note: The term “licensed” refers to a US FDA-approved kit, which is required for all US sites and recommended for non-US ones. For non-US sites that are unable to obtain an FDA-approved kit, a kit that has been certified or licensed by an oversight body within that country and validated internally is acceptable.</p>\n<p style=\"margin-left: 1.5in;\">\n  </p>\n<p style=\"margin-left: 1in;\">\n WHO (World Health Organization) and CDC (Center for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (eg, indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.</p>\n<p style=\"margin-left: 1in;\">\n  </p>\n<p style=\"margin-left: 1in;\">\n CD4+ count > 200 and <u><</u> 350 cells/mm³ obtained within 30 days prior to study entry at a DAIDS-approved laboratory.</p>\n<p>\n  </p>\n<p style=\"margin-left: 1in;\">\n <em>Pf</em> SCP confirmed in a laboratory approved to conduct parasitemia microscopy.</p>\n<p style=\"margin-left: 1in;\">\n  </p>\n<p style=\"margin-left: 1in;\">\n Note: <em>Pf</em> SCP will be defined as meeting all three of the following criteria within 72 hours prior to study entry:</p>\n<p style=\"margin-left: 1in;\">\n  </p>\n<p style=\"margin-left: 1.6in;\">\n Microscopy confirmed parasitemia (see section 6.3.6 and the A5297 Manual of Procedures [MOPS])</p>\n<p style=\"margin-left: 1.6in;\">\n  </p>\n<p style=\"margin-left: 1.6in;\">\n An oral temperature <u><</u> 37.5^°C temperature</p>\n
      • principal_exclusion_criteria<p>\n Previous history or current use of ART. </p>\n<p>\n  </p>\n<p>\n Single dose NVP or dual therapies used for PMTCT within 2 years prior to entry.</p>\n<p>\n  </p>\n<p style=\"margin-left: 1in;\">\n Use of any medication with antimalarial activity, including TMP/SMX (see list of prohibited medications in the A5297 MOPS), within 14 days prior to study entry. </p>\n<p>\n  </p>\n<p style=\"margin-left: 1in;\">\n Confirmed or clinically suspected OIs (including but not limited to tuberculosis, clinical malaria, <em>PCP</em>), or other pulmonary or gastrointestinal infections for which potential participants did not complete treatment more than 30 days prior to enrollment or have signs and symptoms during screening.</p>\n
      • primary_end_points<p>\n The primary endpoint is PCR defined clearance of <em>Pf</em> parasitemia defined as < 10 parasites/µL on three consecutive occasions within a 24-hour period.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyProof of Concept
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<h1>\n 1SITE INVESTIGATORS AND CONTACT INFORMATION</h1>\n<p>\n  </p>\n<p>\n <strong>A) Site Principal Investigator</strong></p>\n<p>\n Dr Josphat K Kosgei, MBChB</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 729 110122</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: josphat.kosgei@usamru-k.org</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <strong>B) Associate Investigators</strong></p>\n<p>\n Dr Fredrick K Kirui, MBBS, MPH, MMed</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O. Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686/+254 52 30388</p>\n<p>\n Mobile: +254 727 531 373</p>\n<p>\n Fax: +254 52 30662/+254 52 30546.</p>\n<p>\n Email: <a href=\"mailto:jkosgei@wrp-kch.org\">fredrick.kirui@usamru-k.org</a></p>\n<p>\n  </p>\n<p>\n Dr Deborah C Langat, MBChB</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O. Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686/+254 52 30388</p>\n<p>\n Mobile: +254 714 059596</p>\n<p>\n Fax: +254 52 30662/+254 52 30546.</p>\n<p>\n Email: <a href=\"mailto:jkosgei@wrp-kch.org\">deborah.langat@usamru-k.org</a></p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n Dr Kathleen C. Rono, MBChB, MPH & TM</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O. Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686/+254 52 30388</p>\n<p>\n Mobile: +254 716 555535</p>\n<p>\n Fax: +254 52 30662/+254 52 30546.</p>\n<p>\n Email: <a href=\"mailto:jkosgei@wrp-kch.org\">krono@wrp-kch.org</a></p>\n<p>\n  </p>\n<p>\n Dr Lucy Koech, MBChB,</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 719 193275</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:fsawe@wrp-kch.org\">lucy.</a>koech@usamru-k.org</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n Dr Fredrick K. Sawe, MBChB, MMED</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 724 255623</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:fsawe@wrp-kch.org\">fsawe@wrp-kch.org, fsawe@hivresearch.org</a></p>\n<p>\n  </p>\n<p>\n Dr Douglas N. Shaffer, MD, MHS</p>\n<p>\n United States Army Medical Research Unit-Kenya</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O. Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686/+254 52 30388</p>\n<p>\n Mobile: +254 716 555535</p>\n<p>\n Fax: +254 52 30662/+254 52 30546</p>\n<p>\n  </p>\n<p>\n <strong>C) Pharmacist</strong></p>\n<p>\n Dr. Noah K. Tarus, B Pharm, MSc</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 30388</p>\n<p>\n Mobile: +254 713 603222</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:ntarus@wrp-kch.org\">noah.tarus@usamru-k.org</a></p>\n<p>\n  </p>\n<p>\n <strong>D) Laboratory Director</strong></p>\n<p>\n Dr Kibet Shikuku, MBChB, MMed</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O. Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686/+254 52 30388</p>\n<p>\n Mobile: +254 716 555537</p>\n<p>\n Fax: +254 52 30662/+254 52 30546.</p>\n<p>\n Email: <a href=\"mailto:jkosgei@wrp-kch.org\">kibet.shikuku@usamru-k.org</a></p>\n<p>\n <strong>E) Data Manager</strong></p>\n<p>\n Ignatius Kiptoo</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O. Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686/+254 52 30388</p>\n<p>\n Mobile: +254 727 531375</p>\n<p>\n Fax: +254 52 30662/+254 52 30546.</p>\n<p>\n Email: <a href=\"mailto:jkosgei@wrp-kch.org\">ignatius.kiptoo@usamru-k.org</a></p>\n<p>\n  </p>\n<p>\n <strong>F) Study Coordinator</strong></p>\n<p>\n Hellen Ngeno, BSN</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 713 603225</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:hngeno@wrp-kch.org\">hngeno@wrp-kch.org</a></p>\n<p>\n  </p>\n<p>\n <strong>G) Local DoD Research  Monitor</strong></p>\n<p>\n <u>Primary DoD Research Monitor</u></p>\n<p>\n  </p>\n<p>\n Dr. Appolonia Aoko, MBChB</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 715 551234</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:aaoko@wrp-kch.org\">aaoko@wrp-kch.org</a></p>\n<p>\n  </p>\n<p>\n Alternate DoD Research Monitor</p>\n<p>\n  </p>\n<p>\n Dr. Jonah Maswai, MBChB, MPH</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 716 430271</p>\n
      • other_details_explanation<p>\n Kenya has a high prevalence of both HIV and Malaria, which is a requirement of the study.</p>\n
      • other_details_regulatory_notapproved<p>\n None.</p>\n
      • other_details_regulatory_approved<p>\n Kenya Medical Research Institute (KEMRI) Ethical Research Committee. Approval date 26 March 2013. This is for Kericho site only.</p>\n
      • other_details_regulatory_rejected<p>\n None.</p>\n
      • other_details_regulatory_halted<p>\n Not Applicable.</p>\n
      • estimated_durationOne year
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorNNRTI arm
      • 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_states4
      • number_of_sites2
      • multi_country_listKenya, Botswana, Malawi, India
      • data_monitoring_committeeYes
      • total_enrolment_per_site20-30
      • total_participants_worldwide52
      • 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_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDavid
      • investigator1_middle_nameC.
      • investigator1_family_nameWekulo
      • investigator1_qualificationBScN
      • investigator1_professional_addressKEMRI WRP P.O. Box 1357-20200 Kericho
      • investigator1_telephone254729110146
      • investigator1_emaildavid.wekulo@usamru-k.org
      • organisations_transferred_Yes
      • number_participants20-30
      • notification
      • approval_date26-03-2013
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted17-03-2020
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<div>\n A5297 is a phase I/II, open-label, proof of concept, two-step, two-arm, controlled randomized clinical trial (RCT) to</div>\n<div>\n test the superiority of lopinavir/ritonavir (LPV/r)-based antiretroviral therapy (ART) to nonnucleoside reverse</div>\n<div>\n transcriptase (nNRTI)-based ART for clearance of Plasmodium falciparum (Pf) subclinical parasitemia (SCP).</div>\n<div>\n Participants were followed for 30 days in order to evaluate parasitemia clearance, Pf parasitemia, gametocytemia,</div>\n<div>\n and plasmepsin sequencing. Participants will have blood collected twice at entry, day 3, 6, 9, 12, 20, and 25 and</div>\n<div>\n three times for day 15 and day 30.</div>\n<div>\n Fifty-two participants (26 per arm) enrolled between January 10, 2014 and May 20, 2016 with 46 (88%) from two</div>\n<div>\n sites in Kenya. Fifty-one participants completed the primary outcome (Step 1) visit, and 49 completed the protocol</div>\n<div>\n as specified. The study population was mostly male (67%) with a median age of 31 (Q1, Q3=24, 39) years. The</div>\n<div>\n median baseline CD4 count was 324 cells/mm3 (259, 404) and median baseline log10 (HIV-1 RNA) was 5.18</div>\n<div>\n copies/mL (4.60, 5.71). The median baseline parasite density was 2.66 log10 parasites/μL (1.92, 3.35) (Table 1).</div>\n<div>\n For the primary outcome, there was no statistically significant difference in clearance between the LPV/r-based</div>\n<div>\n (n=6, 23%) and nNRTI-based (7, 27%) ART arms (Table 2). Sensitivity analyses were conducted around missing data:</div>\n<div>\n one where missing data were assumed to have cleared and one where missing data were excluded. Sensitivity</div>\n<div>\n analyses were also conducted using less stringent definitions of clearance: one where participants were considered</div>\n<div>\n cleared if any 2 of 3 samples had <10 estimated parasites/μL at day 15 by qRT-PCR and one where participants</div>\n<div>\n were considered cleared if any 1 of 3 samples had < 10 parasites/μL at day 15 by qRT-PCR. In all sensitivity</div>\n<div>\n analyses, the difference in clearance between the treatment arms remained non-significant.</div>\n<div>\n Secondary objective analyses included time-to–Pf parasite clearance, between-arm parasite densities over time,</div>\n<div>\n and safety outcomes. No statistically significant differences in time-to-Pf 9 parasite clearance were observed</div>\n<div>\n between arms (P=0.80, Figure 2). Mean Pf parasite densities through the 30-day study window were examined</div>\n<div>\n (Figure 3). While overall, a trend was observed in decreasing Pf parasite densities in both arms throughout the</div>\n<div>\n study, there was no difference between the two treatment arms during days 1-15 (LPV/r Arm median = -0.61 [Q1,</div>\n<div>\n Q3 = -1.78,0.00] and nNRTI Arm -0.46 [-1.31,0.41]) or days 15-30 (LPV/r Arm -1.04 [-2.39,-0.67] and nNRTI Arm -</div>\n<div>\n 1.40 [-2.51,-0.52]). Overall, Pf parasite density decreased between entry and day 30 (-2.36 [-3.46,-0.94]); at the</div>\n<div>\n same time median CD4 counts increased (101 cells/mm3) and median log10 HIV RNA decreased (-2.48 copies/mL)</div>\n<div>\n with no significant between arm differences.</div>\n<div>\n During the study period, there were few adverse events with no hospitalizations. Three cases of uncomplicated,</div>\n<div>\n Grade 2 clinical malaria (LPV/r Arm n=2, nNRTI Arm n=1) occurred during Step 1, and all received SOC</div>\n<div>\n artemether/lumefantrine. One participant in both treatment arms experienced Grade 2 anemia (n=2).</div>\n<div>\n The Study’s results did not find a statistically significant difference in parasite clearance rates nor in time-toparasite</div>\n<div>\n clearance between PI and nNRTI treatment arms. To the Study’s knowledge, the proof-of-concept RCT of</div>\n<div>\n HIV-infected adults beginning first-line ART with Pf SCP is the first direct comparison between a PI (LPV/r) and</div>\n<div>\n nNRTI.</div>\n
      • implication_results<div>\n Yes, from the Primary Manuscript:</div>\n<div>\n  The Study’s results did not find a statistically significant difference in parasite clearance rates</div>\n<div>\n nor in time-to-parasite clearance between PI and nNRTI treatment arms. To the Study’s knowledge, the</div>\n<div>\n proof-of-concept RCT of HIV-infected adults beginning first-line ART with Pf SCP is the first direct</div>\n<div>\n comparison between a PI (LPV/r) and nNRTI.</div>\n<div>\n  The Study provides a unique cohort testing the clinical impact of PIs in a setting without and with</div>\n<div>\n TMP/SMX. While participants had CD4 counts >200 given requirements for TMP/SMX in people with lower</div>\n<div>\n CD4 counts, the Study observed no complicated malaria, PCP, or diarrheal disease.</div>\n<div>\n  Three cases of uncomplicated malaria (parasitemia and fever) during the first 15 days in the absence of</div>\n<div>\n TMP/SMX. This likely reflects fluctuations in SCP in the absence of TMP/SMX and occasional fever</div>\n<div>\n threshold densities being passed.</div>\n<div>\n  This Study also provides unique opportunity for further investigation into parasite and gametocyte life</div>\n<div>\n cycles and kinetics.</div>\n
      • quantity_importedFind attached product accountability documents
      • quantity_dispensedFind attached product accountability documents
      • quantity_destroyedFind attached product accountability documents
      • quantity_exportedFind attached product accountability documents
      • balance_siteFind attached product accountability documents
      • final_date0000-00-00
      • modified2024-06-25 12:46:16
      • created2013-04-04 14:58:19
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id60
        • application_id92
        • given_nameJosphat
        • middle_nameK.
        • family_nameKosgei
        • qualificationMBChB
        • professional_addressKEMRI WRP P.O. Box 1357-20200 Kericho
        • telephone254729110122
        • emailjosphat.kosgei@usamru-k.org
        • created2013-04-04 15:03:34
        • modified2020-03-17 12:04:08
    • SiteDetail(array)
      • 0(array)
        • id80
        • application_id92
        • county_id35
        • site_nameKemri Walter Reed Project-Kericho
        • physical_addressHospital road
        • contact_detailsP.O. Box 1357-20200
        • contact_personJosphat Kosgei
        • site_capacity(null)
        • misc(null)
        • created2013-04-04 15:03:34
        • modified2020-03-17 12:04:08
        • County(array)
          • id35
          • county_nameKericho
          • created2012-06-15 10:26:16
          • modified2012-06-15 10:26:16
      • 1(array)
        • id83
        • application_id92
        • county_id27
        • site_nameMoi University Clinical Research Centre
        • physical_addressMoi Teaching Referral Hospital Building, Nandi Road, Eldoret, Kenya
        • contact_detailsP.O. Box 4604 - 30100 Kenya Tel:254-53 2060850
        • contact_personRonald Kibet
        • site_capacity(null)
        • misc(null)
        • created2013-04-04 17:36:47
        • modified2020-03-17 12:04:08
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
    • Sponsor(array)
      • 0(array)
        • id46
        • application_id92
        • sponsorThe National Institute of Allergy and Infectious Diseases
        • sponsor_typeOthers
        • contact_personBeverly Alston-Smith, MD
        • address6700 B Rockledge Drive, Room 5109 Bethesda, MD 20892-7605
        • telephone_number301-435-3773
        • fax_number301-480-4582
        • cell_number301-435-3773
        • email_addressbalston@niaid.nih.gov
        • created2013-04-04 15:03:34
        • modified2020-03-17 12:04:08
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(array)
    • trial_human_pharmacology1
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
  • 7DebugTimer
  • 8Toolbar
  • 9HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

• 0/var/www/html/ctr/app/Plugin/Media/Lib/mm/src
• 1/var/www/html/ctr/lib
• 3/usr/share/php
• 4/usr/share/pear
• 5-> /var/www/html/ctr/lib/Cake/

Included Files

• core(array)
  • Behavior(array)
    • 0CORE/Model/Behavior/TreeBehavior.php
    • 1CORE/Model/Behavior/ContainableBehavior.php
    • 2CORE/Model/Behavior/AclBehavior.php
  • Cache(array)
    • 0CORE/Cache/Cache.php
    • 1CORE/Cache/Engine/FileEngine.php
    • 2CORE/Cache/CacheEngine.php
  • Component(array)
    • 0CORE/Controller/Component/AclComponent.php
    • 1CORE/Controller/Component/Acl/DbAcl.php
    • 2CORE/Controller/Component/Acl/AclInterface.php
    • 3CORE/Controller/Component/AuthComponent.php
    • 4CORE/Controller/Component/RequestHandlerComponent.php
    • 5CORE/Controller/Component/SessionComponent.php
    • 6CORE/Controller/Component/PaginatorComponent.php
  • Config(array)
    • 0CORE/Config/routes.php
    • 1CORE/Config/config.php
  • Controller(array)
    • 0CORE/Controller/Controller.php
    • 1CORE/Controller/ComponentCollection.php
    • 2CORE/Controller/Component.php
  • Datasource(array)
    • 0CORE/Model/Datasource/CakeSession.php
    • 1CORE/Model/Datasource/Database/Mysql.php
    • 2CORE/Model/Datasource/DboSource.php
    • 3CORE/Model/Datasource/DataSource.php
  • Error(array)
    • 0CORE/Error/exceptions.php
    • 1CORE/Error/ErrorHandler.php
  • I18n(array)
    • 0CORE/I18n/I18n.php
    • 1CORE/I18n/L10n.php
  • Log(array)
    • 0CORE/Log/CakeLog.php
    • 1CORE/Log/LogEngineCollection.php
    • 2CORE/Log/Engine/FileLog.php
    • 3CORE/Log/Engine/BaseLog.php
    • 4CORE/Log/CakeLogInterface.php
  • Model(array)
    • 0CORE/Model/ConnectionManager.php
    • 1CORE/Model/Permission.php
    • 2CORE/Model/Model.php
    • 3CORE/Model/BehaviorCollection.php
    • 4CORE/Model/Aro.php
    • 5CORE/Model/AclNode.php
    • 6CORE/Model/Aco.php
    • 7CORE/Model/ModelBehavior.php
  • Network(array)
    • 0CORE/Network/CakeRequest.php
    • 1CORE/Network/CakeResponse.php
  • Other(array)
    • 0CORE/bootstrap.php
    • 1CORE/basics.php
    • 2CORE/Core/App.php
    • 3CORE/Core/Configure.php
    • 4CORE/Core/CakePlugin.php
    • 5CORE/Event/CakeEventListener.php
    • 6CORE/Event/CakeEvent.php
    • 7CORE/Event/CakeEventManager.php
    • 8CORE/Core/Object.php
  • Routing(array)
    • 0CORE/Routing/Dispatcher.php
    • 1CORE/Routing/Filter/AssetDispatcher.php
    • 2CORE/Routing/DispatcherFilter.php
    • 3CORE/Routing/Filter/CacheDispatcher.php
    • 4CORE/Routing/Router.php
    • 5CORE/Routing/Route/CakeRoute.php
    • 6CORE/Routing/Route/PluginShortRoute.php
  • Utility(array)
    • 0CORE/Utility/Hash.php
    • 1CORE/Utility/Inflector.php
    • 2CORE/Utility/ObjectCollection.php
    • 3CORE/Utility/Debugger.php
    • 4CORE/Utility/String.php
    • 5CORE/Utility/ClassRegistry.php
    • 6CORE/Utility/Set.php
    • 7CORE/Utility/Sanitize.php
  • View(array)
    • 0CORE/View/HelperCollection.php
• app(array)
  • Behavior(array)
    • 0APP/Model/Behavior/SoftDeleteBehavior.php
  • Config(array)
    • 0APP/Config/core.php
    • 1APP/Config/bootstrap.php
    • 2APP/Config/routes.php
    • 3APP/Config/database.php
  • Controller(array)
    • 0APP/Controller/ApplicationsController.php
    • 1APP/Controller/AppController.php
  • Model(array)
    • 0APP/Model/AppModel.php
    • 1APP/Model/Application.php
    • 2APP/Model/User.php
    • 3APP/Model/TrialStatus.php
    • 4APP/Model/InvestigatorContact.php
    • 5APP/Model/Sponsor.php
    • 6APP/Model/SiteDetail.php
    • 7APP/Model/County.php
  • Other(array)
    • 0APP/webroot/index.php
• plugins(array)
  • CakePdf(array)
    • Config(array)
      • 0CakePdf/Config/bootstrap.php
      • 1CakePdf/Config/routes.php
  • CakeResque(array)
    • Config(array)
      • 0CakeResque/Config/bootstrap.php
    • Plugin(array)
      • 0CakeResque/Lib/CakeResque.php
      • 1CakeResque/vendor/kamisama/php-resque-ex/lib/Resque.php
      • 2CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Event.php
      • 3CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Exception.php
  • DebugKit(array)
    • Component(array)
      • 0DebugKit/Controller/Component/ToolbarComponent.php
    • Plugin(array)
      • 0DebugKit/Lib/DebugMemory.php
      • 1DebugKit/Lib/Panel/HistoryPanel.php
      • 2DebugKit/Lib/DebugPanel.php
      • 3DebugKit/Lib/Panel/SessionPanel.php
      • 4DebugKit/Lib/Panel/RequestPanel.php
      • 5DebugKit/Lib/Panel/SqlLogPanel.php
      • 6DebugKit/Lib/Panel/TimerPanel.php
      • 7DebugKit/Lib/Panel/LogPanel.php
      • 8DebugKit/Lib/Log/Engine/DebugKitLog.php
      • 9DebugKit/Lib/Panel/VariablesPanel.php
      • 10DebugKit/Lib/Panel/EnvironmentPanel.php
      • 11DebugKit/Lib/Panel/IncludePanel.php
      • 12DebugKit/Lib/DebugTimer.php
  • Media(array)
    • Config(array)
      • 0Media/Config/bootstrap.php
    • Plugin(array)
      • 0Media/Lib/mm/src/Mime/Type.php
      • 1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
      • 2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
      • 3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
      • 4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
      • 5Media/Lib/mm/src/Media/Process.php
      • 6Media/Lib/mm/src/Media/Info.php
  • Search(array)
    • Component(array)
      • 0Search/Controller/Component/PrgComponent.php
    • Behavior(array)
      • 0Search/Model/Behavior/SearchableBehavior.php
  • Shim(array)
    • Config(array)
      • 0Shim/Config/bootstrap.php
  • Tools(array)
    • Config(array)
      • 0Tools/Config/bootstrap.php