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      • id416
      • user_id137
      • trial_status_id5
      • abstract_of_study<p>\n This study (VAC-040) is required to assess the safety and tolerability of the single-vial formulation of PATH-wSP manufactured by BioFarma, prior to use of this new formulation in such an infant population in a Phase 2 dose-ranging, proof-of-concept study. This randomized, placebo-controlled, double-blind trial is designed to sequentially evaluate PATH‑wSP at two escalating doses (0.6 mg and 1 mg) in both adults and toddlers.  The following cohorts will be tested:</p>\n<p>\n <strong>Adult (18-40 years old) Cohorts: </strong></p>\n<p style=\"margin-left:.25in;\">\n ·       Two 0.6 mg doses of PATH-wSP (18 subjects) <strong>or</strong> saline (6 subjects) with a 28-day interval between doses.</p>\n<p style=\"margin-left:.25in;\">\n ·       Two 1 mg doses of PATH-wSP (18 subjects) <strong>or</strong> saline (6 subjects) with a 28-day interval between doses.</p>\n<p>\n <strong>Toddler (12-19 months old) Cohorts</strong>:</p>\n<p style=\"margin-left:.25in;\">\n ·       Two 0.6 mg doses of PATH-wSP (18 subjects) <strong>or</strong> saline (6 subjects) with a 28-day interval between doses, and pentavalent vaccine co-administered with the second dose.</p>\n<p>\n Two 1 mg doses of PATH-wSP (50 subjects) <strong>or</strong> saline (25 subjects) with a 28-day interval between doses, and pentavalent vaccine co-administered with the second dose.</p>\n<p>\n Each participant (adults and toddlers) will undergo a total of 6 scheduled visits, including at least one screening visit, two vaccination visits (scheduled 28 days apart), two safety visits at 7 days post each vaccination and a final visit at 28 days post the final vaccination.  In addition, daily reactogenicity assessments for 7 days post vaccination will be completed by fieldworkers using a standard home visit diary.  Participants will be followed beyond 28 days post final visit if they have ongoing adverse events or have laboratory abnormalities that require continued monitoring.  </p>\n<p>\n Primary objectives of this study are:</p>\n<ol>\n <li>\n To evaluate the safety and tolerability of 2 dose levels (0.6 mg and 1 mg) of PATH-wSP vaccine, administered in a 2-series schedule, through 4 weeks post vaccination in healthy adults.</li>\n <li>\n To evaluate the safety and tolerability of 2 dose levels (0.6 mg and 1 mg) of PATH-wSP vaccine, administered in a 2-series schedule, through 4 weeks post vaccination in healthy toddlers when co-administered with a booster dose of licensed pentavalent vaccine (diphtheria, tetanus, whole-cell pertussis, <em>Haemophilus influenzae</em> type b, and hepatitis B combined vaccine) at the second vaccination.</li>\n</ol>\n
      • study_title<p>\n A Phase 1/2, Randomized, Placebo-controlled, Double-blind Study to Assess the Safety, Tolerability, and Immunogenicity of <em>Stretococcus pneumoniae </em>Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide (PATH-wSP) in Healthy Kenya Young Adults (18 - 40years) and Toddlers (12 - 19months)</p>\n
      • laymans_summary(null)
      • short_titleVAC040
      • protocol_noECCT/15/11/04
      • version_no2.0
      • date_of_protocol18-09-2015
      • study_drugPATH-wSP is an adsorbed suspension of Streptococcus pneumoniae Whole Cell Vaccine [SPWCV] and Alum
      • disease_conditionActive Immunization for the prevention of Pneumococcal disease
      • 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_addresskenya-vac010@fhi360.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_applicantGeorge Belai
      • declaration_date113-11-2015
      • declaration_principal_investigatorAnthony Scott
      • declaration_date213-11-2015
      • placebo_presentYes
      • study_objectives(null)
      • principal_inclusion_criteria<ul>\n <li>\n Healthy adults who are 18 to 40 years old, or toddlers who are 12 to 19 months old on the day of randomization (Day 0), inclusive of the age ranges.</li>\n <li>\n Participants (or parent in the case of toddlers) must provide voluntary written/thumb-printed informed consent for the subject to participate in the study.</li>\n <li>\n Participants (or parent in the case of toddlers) must be able to comprehend and comply with study requirements and procedures and must be willing and able to return for all scheduled follow-up visits.</li>\n <li>\n Participants (or parent in the case of toddlers) must have a readily identifiable place of residence to ensure home visits can be undertaken reliably and must also have a consistent means of telephone contact for the duration of trial participation.</li>\n <li>\n Participants must be resident in the study area with no plans to travel outside the study area during the period of study participation.</li>\n <li>\n Participants must be willing to not consume (ingest) herbal or other local traditional medications within 28 days of randomization and during the course of the study.  Subject’s parent(s) must be willing to not administer such medications to their toddler, and subject’s mother must be willing to not consume herbal medication that may transmit to her toddler through breast milk.</li>\n</ul>\n<p>\n <strong>Adults only</strong></p>\n<ul>\n <li>\n Adult female participants must have a negative serum pregnancy test at screening and urine pregnancy test prior to each vaccination.  They will be advised through the informed consent process to avoid becoming pregnant for the duration of the study, and must agree to employ an effective form of birth control for the duration of the study.  Adult female subjects with documented sterilization via tubal ligation or hysterectomy may be eligible for the study without required use of birth control.</li>\n</ul>\n<p>\n Note: Effective forms of birth control are the following: credible history of continuous abstinence from heterosexual activity, hormonal contraceptives (oral, injectable, implant, patch, and ring), double-barrier contraceptives (condom or diaphragm, either with spermicide) and intrauterine device.  When using contraceptives, subjects must have been using their current contraceptive for the past two months to be eligible.</p>\n<p>\n <strong>Toddlers only:</strong></p>\n<ul>\n <li>\n Toddlers must have been born full-term, and have a mid-upper arm circumference > 11.5 cm at the time of enrollment.</li>\n <li>\n Toddlers must have completed their Kenyan infant EPI schedule (Table 5) through 9 months, with the following <u>minimum</u> requirements: 1 birth dose of BCG, 3 doses of DTwPHibHep, 3 doses of OPV (birth dose is not required), 3 doses of PCV, and 1 dose of measles vaccine.  If additional vaccines are introduced into the routine EPI schedule in Kenya or are given in campaigns during the period of the study, receipt of these vaccines would not be required for a toddler to be eligible for randomization</li>\n</ul>\n
      • principal_exclusion_criteria<p style=\"margin-left:.25in;\">\n A participant who meets any of the following criteria at screening will not be eligible for randomization but may be reconsidered based on resolution of exclusion criteria at a later date if reevaluation falls within the screening period:Use of any investigational or nonregistered drug within 90 days of randomization or planned during the course of study participation.</p>\n<ul>\n <li style=\"margin-left: 0.25in;\">\n Use of any of the potentially hepatotoxic drugs listed in Appendix 9 within 28 days of randomization or during the course of study participation.  This list will be provided to all participants/participant's parents at screening, who will be instructed to notify study staff immediately in the event that use of any listed drug becomes necessary.</li>\n <li style=\"margin-left: 0.25in;\">\n History of administration of any licensed vaccine within 14 days of administration of study vaccine.  Administration of any licensed, non-study vaccine during enrollment is prohibited through at least 14 days after final study vaccination.  If additional vaccines are introduced into the routine EPI schedule in Kenya or are given in campaigns during the period of the study, receipt of these vaccines would not exclude a toddler unless administration of the vaccine was considered to alter the safety of the study participant or to influence the assessment of the primary or secondary endpoints in some significant way.</li>\n <li style=\"margin-left: 0.25in;\">\n Chronic, clinically significant pulmonary, cardiovascular, hepatobiliary, gastrointestinal, renal, neurological, or hematological functional abnormality or major congenital defects or illness that requires medical therapy, based on medical history or clinical assessment.</li>\n <li style=\"margin-left: 0.25in;\">\n History of anaphylactic shock.</li>\n <li style=\"margin-left: 0.25in;\">\n History of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines.</li>\n <li style=\"margin-left: 0.25in;\">\n History of immunosuppression or immunodeficiency, inclusive of human immunodeficiency virus (HIV) infection by medical history (including that of an enrolled toddler’s mother) or by HIV testing at screening.  Toddler participants will be excluded if their mother is known to be HIV positive from testing during the perinatal or post-delivery period.</li>\n <li style=\"margin-left: 0.25in;\">\n Evidence of active hepatitis infection (B or C) by serologic testing at screening.</li>\n <li style=\"margin-left: 0.25in;\">\n Any screening laboratory test (chemistry or hematology) or vital sign measurement with toxicity grade ≥ 1.  A participant may repeat each abnormal laboratory assessment or vital sign once during the screening period for a subject to remain eligible for randomization.</li>\n <li style=\"margin-left: 0.25in;\">\n Acute illness (moderate or severe) and/or fever (axillary temperature ≥ 37.5°C).</li>\n</ul>\n<p style=\"margin-left:.25in;\">\n Note: Participants with an acute illness/fever may return once for a repeat screening visit within the 28-day screening period and still qualify for randomization if the acute illness has resolved.  A minimum of 72 hours following a <u>documented</u> fever must pass before the subject can be re-screened and vaccinated.</p>\n<ul>\n <li style=\"margin-left: 0.25in;\">\n Positive test for malaria (blood film) at screening that remains positive post treatment when retested prior to vaccination.</li>\n</ul>\n<p>\n Note: Participants may be treated for malaria and retested during the screening period.  A rapid antigen test for malaria will be undertaken on the day of each vaccination to ensure a subject with a concurrent malaria infection is not vaccinated.</p>\n<ul>\n <li>\n Disorders that require chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within the past 6 months prior to the administration of the study vaccine.  An immunosuppressant dose of glucocorticoid will be defined as a systemic dose >10 mg of prednisone per day for adults or equivalent in toddlers.  The use of topical glucocorticoids will be permitted.</li>\n <li>\n Administration of immunoglobulins and/or any blood products within the 6 months preceding enrollment in the study, or anticipation of such administration during the study period.</li>\n <li>\n Known disturbance of coagulation or other blood disorder (e.g., thalassemia, sickle cell disease, thrombocytopenia, disorders of the lymphocytes, severe anemia at birth) in adult participant or in self/first-degree relative of toddler participant; or receipt of anticoagulants in the past three weeks (aspirin as needed and nonsteroidal anti-inflammatory drugs are acceptable).</li>\n <li>\n History of meningitis, seizures or any neurological disorder (all participants) or major psychiatric disorder (adults).</li>\n <li>\n Any medical or social condition that in the opinion of the investigator will interfere with the study objectives or pose a risk to the study participant or may prevent the participant from completing the study follow-up.</li>\n <li>\n An employee (or first-degree relative of employee) of the Sponsor, the CRO, or any investigator or site personnel.</li>\n</ul>\n<p>\n <strong>Adults only</strong></p>\n<ul>\n <li>\n Female participants who are pregnant or breast-feeding.</li>\n <li>\n Suspicion or recent history (within the past year) of alcohol or substance abuse.</li>\n</ul>\n<p>\n <strong>Toddlers only</strong></p>\n<ul>\n <li>\n Prior vaccination with a pentavalent booster (following the primary series).</li>\n <li>\n Family history of suspected primary immunodeficiency in first-degree relative.</li>\n <li>\n Had a sibling die of likely sudden infant death syndrome (SIDS) or die suddenly and <u>without</u> apparent other cause or preceding illness in the first year of life.</li>\n <li>\n Has evidence of a clinically significant congenital abnormality as judged by the PI.</li>\n <li>\n Evidence of fetal alcohol syndrome or maternal history of alcohol abuse during pregnancy.</li>\n</ul>\n
      • primary_end_points<p>\n <strong>Safety</strong>:</p>\n<p>\n Safety and tolerability of PATH-wSP vaccine including co-administration of PATH-wSP and licensed pentavalent vaccine at the second vaccination to toddlers will be evaluated based on the following analyses:</p>\n<ul>\n <li>\n Occurrence and severity of solicited local and systemic adverse events (AEs) and clinical laboratory abnormalities through 1 week post vaccination.</li>\n <li>\n Occurrence, severity, and relatedness to vaccination of all AEs and serious adverse events (SAEs) through 4 weeks post vaccination.</li>\n</ul>\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_specifyTolerability
      • 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<p>\n A. Site staff The research site is well equipped with various clinical research expertise: 4 Physician Principal Investigators; 3 Non-Physician Principal Investigators; 1 Clinical Research Coordinator; 2 Clinical officers; 3 Research Nurses; 1 Laboratory technologists 1 Pharmacist; 1 Pharmaceutical Technologist; 5 Fieldworkers 1 Data manager and 3 Data clerks.</p>\n<p>\n B. Operation Hours The clinic operates for 8 hours (8am – 4pm) 5 days a week. After-hours, weekends and public holidays, participants who need to be reviewed will be seen at Kilifi County hospital by the research staff. All departments are sufficiently covered and operate fully from Monday to Friday 0800 to 1600 hours. The principal Investigator, study clinicians and field staff, are always on call throughout and can be reached as necessary.</p>\n<p>\n C. Clinical and research Services The site has a HDSS, the Kilifi Health Demographic Surveillance System which they use to locate potential research subjects. The site staff has been trained on Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP) and human Subject Protection in addition to their professional competencies. Clinical facilities providing healthcare to research participants include: Outpatient Clinics and in-patient Adult and Pediatric Wards with a high dependence unit in the Kilifi County Hospital, Research Laboratories, Radiology Facilities, Pharmacy, Clinical Trials Facility, Administrative Offices and IT department. The site has capacity for and has previously been involved in Phase 1, 2, and 3 trials.</p>\n<p>\n D. Laboratory services Clinical laboratory is equipped to handle various tests including: Hematology, Biochemistry, Microbiology, and Microscopy. The Research Laboratory has capability of Immunoglobulin isotyping analysis, Conventional and real time Quantitative Polymerase Chain Reaction (qRT-PCR, 8color (FACS Canto) flow cytometry capabilities for phenotyping cellular surface molecules and intra-cellular staining, HPLC analysis for hemoglobin genotype screening, Serological assay capabilities (ELISA), specimen storage-15 minus-80 degrees freezers.</p>\n<p>\n E. Sample Collection and processing Samples collection is done at the phlebotomy room, which is furnished with phlebotomy chairs and worktops. At the phlebotomy room participants are appropriately identified and logged in the study phlebotomy log book capturing all the relevant details. After sample collection the sample is transported to the processing area under optimal conditions where they are logged in, processed and analyzed as appropriate and the ones to be stored are transferred to storage area/freezer room where they are stored until when they are due for further analysis at the site or shipment to next destination as specified in the protocol. The results are reviewed and verified before they are dispatched to the clinician for patient management and transcription onto the paper CRF.</p>\n<p>\n F. Data Entry and Query Handling Data collection is done on source documents then transcribed into paper CRF before being entered into eCRF. All data collected is identified using each participant’s unique study number. All areas where paper and electronic data are stored have controlled access, the cabinets are lockable and the computers are password protected. Queries are raised during internal quality check and are flagged to be resolved by the staff who made the error. Queries on eCRF are raised electronically during data cleaning and responded to by the IT and clinical team.</p>\n
      • other_details_explanation<p>\n The <em>Streptococcus pneumoniae</em> vaccine (PATH-wSP) is a whole cell pneumococcal vaccine in development for use in countries where conjugate pneumococcal vaccines are cost prohibitive.  It is anticipated that PATH-wSP would be administered in conjunction with other vaccines currently endorsed by WHO for an infant Expanded Program on Immunization (EPI).  This would include combination vaccines that specifically have other whole cell components.  Therefore the clinical development plan is designed to test the safety of PATH-wSP co-administered with a pentavalent combination vaccine which contains a whole cell pertussis component.  Such a trial could not be conducted in the USA, where only acellular pertussis is being used.  The EPI program in Kenya includes administration of whole cell pertussis.  Given that pneumonia remains an important cause of infant mortality in Kenya, the Kenyan people would benefit greatly from introduction of an effective and less costly vaccine against pneumococcus.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected<p>\n Not Applicable</p>\n
      • other_details_regulatory_halted<p>\n Not Applicable</p>\n
      • estimated_duration12 months in the field
      • 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_comparatornormal saline control
      • design_controlled_other_medicinalYes
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI-Wellcome Trust Research Program
      • single_site_physical_addressCenter for Geographic Medicine, PO Box 230, Kilifi 80108, Kenya
      • single_site_contact_personDr. Anthony Scott
      • single_site_telephone+254 705 412719
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site147 participants
      • total_participants_worldwide147 participants
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameJohn Anthony
      • investigator1_middle_name
      • investigator1_family_nameScott
      • investigator1_qualificationBM BCh, MSc
      • investigator1_professional_addressKEMRI-Wellcome Trust Research Programme, PO Box 230, Kilifi 80108, Kenya
      • investigator1_telephone+254 705 412719
      • investigator1_emailascott@ikilifi.org
      • organisations_transferred_Yes
      • number_participants48 adults (18-40 years) and 99 toddlers (12-19 months)
      • notification<p>\n None</p>\n
      • approval_date09-02-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted13-11-2015
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<div>\n SYNOPSIS</div>\n<div>\n Sponsor: PATH Vaccine Solutions</div>\n<div>\n  </div>\n<div>\n Name of Test Article: PATH-wSP</div>\n<div>\n  </div>\n<div>\n Study Title: A Phase 1/2, Randomized, Placebo-Controlled, Observer-Blind Study to Assess the Safety, Tolerability, and Immunogenicity of Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide (PATH-wSP) in Healthy Kenyan Young Adults (18 to 40 years) and Toddlers (12 to 21 months)</div>\n<div>\n  </div>\n<div>\n Investigator and Study Center: This study was conducted at a single center in Kenya. The Principal Investigator was Anthony Scott, MBChB, DTM & H, MSc.</div>\n<div>\n  </div>\n<div>\n Publications: None</div>\n<div>\n  </div>\n<div>\n Phase: 1/2</div>\n<div>\n Initiation Date (first subject enrolled): 10 August 2016</div>\n<div>\n  Objectives:</div>\n<div>\n <strong>Primary Objectives</strong></div>\n<div>\n  </div>\n<div>\n •   To evaluate the safety and tolerability of 2 dose levels (0.6 mg and 1.0 mg) of Streptococcus pneumoniae whole cell antigen with aluminum hydroxide adjuvant PATH-wSP vaccine, administered in a 2-series schedule, 4 weeks apart, in healthy adults.</div>\n<div>\n  </div>\n<div>\n •   To evaluate the safety and tolerability of 2 dose levels (0.6 mg and 1.0 mg) of PATH-wSP vaccine, administered in a 2-series schedule, 8 weeks apart, in healthy toddlers when co-administered with a booster dose of licensed pentavalent vaccine (diphtheria, tetanus, whole cell pertussis, Haemophilus influenzae type b [Hib], and hepatitis B combined vaccine) at the second vaccination.</div>\n<div>\n <div>\n <strong>Secondary Objective</strong></div>\n <div>\n •   To assess immunogenicity of PATH-wSP vaccine when given as a 2-vaccination series to adults and toddlers.</div>\n <div>\n  </div>\n <div>\n <strong>Exploratory Objectives</strong></div>\n <div>\n  </div>\n <div>\n •   To evaluate the potential for sera from PATH-wSP-immunized subjects to afford passive protection in an animal challenge model (subset of subjects).</div>\n <div>\n  </div>\n <div>\n •   To identify novel antibody targets for future vaccine candidates using peripheral blood mononuclear cells (PBMCs; i.e., lasmablasts) stimulated in vitro (adults only).</div>\n <div>\n  </div>\n <div>\n <div>\n METHODS</div>\n <div>\n Design: This single-center, observer-blind, Phase 1/2 study was for the sequential testing of 2 escalating doses of PATH-wSP (0.6 mg and 1.0 mg) in healthy adults followed by toddlers.</div>\n <div>\n  </div>\n <div>\n This study was a dose escalation study, and sequential cohorts of subjects were identified to allow safety evaluations of dosing to occur progressively during the study. The following PATH-wSP cohorts were defined for adult and toddler subjects:</div>\n <div>\n  </div>\n <div>\n •   Adult Cohort 1: Two 0.6 mg doses of PATH-wSP (12 subjects) or saline (12 subjects) with a 28-day interval between doses.</div>\n <div>\n <div>\n Adult Cohort 2: Two 1.0 mg doses of PATH-wSP (12 subjects) or saline (12 subjects) with a 28-day interval between doses.</div>\n <div>\n  </div>\n <div>\n •   Toddler Cohort 1: Two 0.6 mg doses of PATH-wSP (50 subjects) or saline (50 subjects) with a 56-day interval between doses, and pentavalent vaccine co-administered with the second dose.</div>\n <div>\n  </div>\n <div>\n •   Toddler Cohort 2: Two 1.0 mg doses of PATH-wSP (50 subjects) or saline (50 subjects) with a 56-day interval between doses, and pentavalent vaccine co-administered with the second dose.</div>\n <div>\n  </div>\n <div>\n Because of a safety signal observed among toddlers in a previous study, safety monitoring focused on cases of suspected pneumonia.</div>\n <div>\n  </div>\n <div>\n Number of Subjects (planned and analyzed): A total of 48 adults (24 subjects per cohort) and 200 toddlers (100 subjects per cohort) were planned and enrolled in the study.</div>\n <div>\n  </div>\n <div>\n Diagnosis and Main Criteria for Inclusion: Healthy adults who were 18 to 40 years old, inclusive, or toddlers who were 12 to 21 months old, inclusive, on the day of randomization (Day 0) were eligible for inclusion. Toddlers must have completed their primary Expanded Programme on Immunization vaccines with, at minimum, 1 Bacille Calmette-Guérin, 3 diphtheria and tetanus toxoid </div>\n <div>\n with whole cell pertussis, Hib, and hepatitis B, 1 measles, 3 oral polio (with the exception of the birth dose), 3 pneumococcal conjugate, and 2 rotavirus vaccinations.</div>\n <div>\n  </div>\n <div>\n Investigational Products, Dose and Mode of Administration, Batch Number: </div>\n <div>\n PATH-wSP vaccine or saline was administered as a 2-vaccination series intramuscularly at Weeks 0 and 4 in adults at 0.6 or 1.0 mg or Weeks 0 and 8 in toddlers at 0.6 or 1.0 mg, with a pentavalent vaccine co-administered with the second dose. For both cohorts, Batch 8020115 was the 0.6-mg dose and Batch 8030115 was the 1.0-mg dose.</div>\n <div>\n <strong> Endpoints:</strong></div>\n <div>\n <strong>Primary Endpoints</strong></div>\n <div>\n  </div>\n <div>\n Safety and tolerability of PATH-wSP vaccine including co-administration of PATH-wSP and licensed pentavalent vaccine at the second vaccination to toddlers will be evaluated based on the following analyses:</div>\n <div>\n  </div>\n <div>\n •   Occurrence and severity of solicited local and systemic adverse events (AEs) and clinical laboratory abnormalities through 1 week post-vaccination.</div>\n <div>\n  </div>\n <div>\n •   Occurrence, severity, and relatedness to vaccination of unsolicited AEs and serious adverse events (SAEs) from Day 0 through the last study contact.</div>\n <div>\n  </div>\n <div>\n Secondary Endpoints</div>\n <div>\n  </div>\n <div>\n The immunoglobulin G (IgG) response to pneumococcal-specific proteins (pneumolysoid and pneumococcal surface protein A family 1 [PspA-Fam1]) measured by enzyme-linked immunosorbent assay, and the IgG response to 9 pre-selected pneumococcal proteins measured on the Meso Scale Discovery platform, will be evaluated based on the following analyses:</div>\n <div>\n  </div>\n <div>\n •   IgG geometric mean concentration and geometric mean fold rise (GMFR) (from baseline) 4 weeks after the second vaccination.</div>\n <div>\n  </div>\n <div>\n •   Percentage of subjects with IgG concentration of a predefined threshold level (responders), measured 4 weeks after the second vaccination.</div>\n <div>\n <div>\n <strong>Endpoints:</strong></div>\n <div>\n <strong>Primary Endpoints</strong></div>\n <div>\n  </div>\n <div>\n Safety and tolerability of PATH-wSP vaccine including co-administration of PATH-wSP and licensed pentavalent vaccine at the second vaccination to toddlers will be evaluated based on the following analyses:</div>\n <div>\n  </div>\n <div>\n •   Occurrence and severity of solicited local and systemic adverse events (AEs) and clinical laboratory abnormalities through 1 week post-vaccination.</div>\n <div>\n  </div>\n <div>\n •   Occurrence, severity, and relatedness to vaccination of unsolicited AEs and serious adverse events (SAEs) from Day 0 through the last study contact.</div>\n <div>\n  </div>\n <div>\n <strong>Secondary Endpoints</strong></div>\n <div>\n  </div>\n <div>\n The immunoglobulin G (IgG) response to pneumococcal-specific proteins (pneumolysoid and pneumococcal surface protein A family 1 [PspA-Fam1]) measured by enzyme-linked immunosorbent assay, and the IgG response to 9 pre-selected pneumococcal proteins measured on the Meso Scale Discovery platform, will be evaluated based on the following analyses:</div>\n <div>\n  </div>\n <div>\n •   IgG geometric mean concentration and geometric mean fold rise (GMFR) (from baseline) 4 weeks after the second vaccination.</div>\n <div>\n  </div>\n <div>\n •   Percentage of subjects with IgG concentration of a predefined threshold level (responders), measured 4 weeks after the second vaccination.</div>\n <div>\n  </div>\n </div>\n </div>\n </div>\n</div>\n<p>\n <strong><u> RESULTS</u></strong></p>\n<div>\n <u>Subject Disposition</u>: A total of 85 adult subjects were screened in the adult cohort, and 48 subjects were randomized: 12 subjects in each of the 0.6 mg PATH-wSP, 1.0 mg PATH-wSP, Cohort 1 Saline, and Cohort 2 Saline groups. All subjects completed the Day 56 safety visit. All but 1 subject missed no home visits. Two subjects discontinued after randomization.</div>\n<div>\n  </div>\n<div>\n A total of 388 toddler subjects were screened in the toddler cohort, and 200 subjects were randomized:50 subjects in each of the 0.6 mg PATH-wSP, 1.0 mg PATH-wSP, Cohort 1 Saline, and Cohort 2 Saline groups. Overall, 99.5% of subjects completed all clinic visits. Only 3 toddlers missed at least 1 home visits; no toddlers missed all home visits. Three (1.5%) toddlers discontinued after randomization. One toddler’s parent withdrew consent for further blood draws after the first vaccination, and 1 toddler was discontinued after safety unblinding, but both toddlers continued safety assessments. The third toddler’s parent withdrew consent from the study after receiving both vaccines and exited the study.</div>\n<div>\n  </div>\n<div>\n Baseline Demographics: Overall, there were 30 men (62.5%) and 18 women (37.5%) in the adult cohort; which were consistent across treatment groups. The mean (SD) age of all adult subjects was  28.4 (6.63) years. The mean (SD) height of all adult subjects was 162.1 (7.64) cm, and the mean (SD) weight was 57.9 (8.99) kg, with no major variations in height and weight between groups.</div>\n<div>\n  </div>\n<div>\n The proportion of male (46.5%) and female (53.5%) toddlers was well balanced. The mean (SD) age of all toddler subjects was 16.4 (2.58) months. The mean (SD) height of all toddler subjects was 76.0 (5.33) cm, and the mean (SD) weight was 9.1 (1.25) kg, with no major variations in height and weight between groups.</div>\n<div>\n  </div>\n<div>\n No noteworthy differences were observed between treatment groups in any demographic characteristic.  Immunogenicity Results: Tested dose levels of PATH-wSP induced a modest immune response against multiple pneumococcal proteins at approximately 1 month after each of a 2-dose vaccination series. </div>\n<div>\n In both adults and toddlers, immune responses based on GMFR ratio comparisons between the 0.6 mg and 1.0 mg dose level of PATH-wSP were mostly similar after Vaccination 2; however, there was a slight increase in immune response with 1.0 mg in toddlers. In the adult cohort, there were greater proportions of higher fold rises in the 0.6 mg PATH-wSP group compared with the 1.0 mg PATH-wSP group post- Vaccination 2. When comparing the PATH-wSP doses in toddler subjects, the proportion of</div>\n<div>\n seroresponders showed variable results based on the specific pneumococcal proteins. Taken together, the results do not suggest a dose-dependent immune response to pneumococcal antigens.</div>\n<div>\n Safety Results: Overall, PATH-wSP was well-tolerated in both age cohorts, and there were no notable changes in safety laboratory parameters, including all liver function-related assays. Most reactogenicity events (REs) were mild or moderate and resolved within 24 to 48 hours. Differences in reactogenicity between PATH-wSP and Saline groups were primarily minor and limited to REs of mild or moderate severity. The incidence of Grade 1 and 2 pain and swelling/hardness at the injection site was higher in adults receiving PATH-wSP than in those that received saline. Similarly, the incidence of local reactions (including Grade 1 and 2 tenderness and swelling/hardness at the injection site) was higher in toddlers receiving PATH-wSP than in the saline cohorts. Post-vaccination loss of appetite and irritability were frequent in the toddler cohort, although there was no difference in incidence between treatment groups. In general, REs did not differ between Vaccination 1 and 2 in the adult cohort and were only</div>\n<div>\n slightly more frequent and severe after Vaccination 2 in the toddler cohort.</div>\n<div>\n <div>\n While treatment-emergent adverse events (TEAEs) were common in both adult and toddler cohorts, most were considered not treatment related. Reported vaccine-related TEAEs were all in the toddler cohort and resolved during the study. Mild vaccination site induration (in 2 subjects in the 1.0 mg PATH-wSP group) was the only vaccine-related TEAE reported in PATH-wSP groups and hence the only observed adverse drug reaction.</div>\n <div>\n  </div>\n <div>\n Pneumonia was not observed in the adult cohort and was infrequent in the toddler cohort, with no notable trends across treatment groups.</div>\n <div>\n  </div>\n <div>\n In toddlers, there was a trend toward increased relative risk of non-severe lower respiratory tract infections (LRTIs) in the 0.6 mg PATH-wSP group associated with increased rates of upper respiratory tract infections (URTIs) during Cohort 1. It is noteworthy that Cohort 1 was conducted during what is historically the peak respiratory syncytial virus (RSV) season in Kilifi, Kenya.</div>\n <div>\n  </div>\n <div>\n There were no treatment-emergent SAEs in the adult cohort. Fourteen treatment-emergent SAEs were reported in the toddler cohort, but with no notable trends across treatment groups. The only SAEs that were considered vaccine-related at the time of their occurrence were 3 events reported in the toddler Saline group. All SAEs resolved during the study.</div>\n <div>\n  </div>\n <div>\n There were no deaths during the study.</div>\n <div>\n No subjects had a TEAE leading to study discontinuation.</div>\n <div>\n  There were no notable trends from baseline to post-vaccination in clinical laboratory parameters or vital signs in either the adult or toddler cohorts. Overall, few subjects in either cohort had abnormal physical examination findings post-vaccination, and these were related to reported AEs when detected.</div>\n <div>\n  </div>\n <div>\n CONCLUSIONS: The PATH-wSP vaccine was well-tolerated in all age cohorts with no meaningful difference in rates of local and systemic solicited AEs (reactogenicity) following vaccination with PATH-wSP. When observed, reactogenicity was primarily mild or moderate and of limited duration.</div>\n <div>\n  </div>\n <div>\n Most TEAEs were unrelated to the study vaccine and all related TEAEs resolved during the study. No vaccine-related treatment-emergent SAEs were observed in any subject that received PATH-wSP. There There were no notable trends from baseline to post-vaccination in clinical laboratory parameters or vital signs in either the adult or toddler cohorts. Overall, few subjects in either cohort had abnormal  physical examination findings post-vaccination, and these were related to reported AEs when detected.</div>\n <div>\n <div>\n  </div>\n <div>\n CONCLUSIONS: The PATH-wSP vaccine was well-tolerated in all age cohorts with no meaningful difference in rates of local and systemic solicited AEs (reactogenicity) following vaccination with PATH-wSP. When observed, reactogenicity was primarily mild or moderate and of limited duration.</div>\n <div>\n  </div>\n <div>\n Most TEAEs were unrelated to the study vaccine and all related TEAEs resolved during the study. No vaccine-related treatment-emergent SAEs were observed in any subject that received PATH-wSP. There were no meaningful trends in either SAEs or vaccine-related TEAEs. No deaths were reported during the study and no subject had a TEAE leading to discontinuation of the vaccination schedule.</div>\n <div>\n  </div>\n <div>\n Pneumonia cases were not observed in the adult cohort and were infrequent in the toddler cohort, with no notable trends across treatment groups. A higher incidence of LRTIs was observed in the PATH-wSP 0.6 mg toddler group than in the corresponding saline group. This imbalance in LRTIs between the active and control groups in Cohort 1 was within random fluctuation in relative risk of LRTI (95%  confidence interval [CI]: 0.63, 26.2), and was limited to cases of mild-to-moderate severity. It is, however, notable when considered in the context of the increased relative risk of (primarily mild) LRTIs observed in the</div>\n <div>\n 0.6 mg PATH-wSP group of the VAC-010 study (2.21 at lower limit of 95% CI). The trend toward an increased relative risk of non-severe LRTIs in the 0.6 mg PATH-wSP toddler group of the current study was associated with a significant seasonal imbalance in the incidence of URTIs between Cohort 1 (38.0% to 54.0%) and Cohort 2 (6% to 8%). Similarly, the onset of LRTI events in the combined 0.6 mg PATH- wSP group of the VAC-010 study also occurred during peak RSV season in Western Kenya where </div>\n <div>\n the study was conducted. This suggests that PATH-wSP vaccination may, in the context of viral URTI, potentiate LRTIs of primarily mild to-moderate severity in toddlers.</div>\n <div>\n  </div>\n <div>\n Tested doses of PATH-wSP injections induced an immune response against multiple pneumococcal proteins. In both adults and toddlers, immune response based on GMFR ratio comparisons between the 0.6 mg and 1.0 mg dose of PATH-wSP was mostly similar after Vaccination 2; however, there was a slight increase in immune response with 1.0 mg in toddlers.</div>\n <div>\n  In addition to the GMFR analysis, the proportion of adult and toddler subjects presenting a 2-fold, 3-fold or 4-fold response to the pre-selected pneumococcal proteins was evaluated. Overall, less than approximately 20% of the subjects tested developed a 3-fold or higher response rate, while less than 50% developed a 2-fold or higher response rate.</div>\n <div>\n  </div>\n <div>\n In the adult cohort, there were greater proportions of higher fold rises in the 0.6 mg PATH-wSP group compared with the 1.0 mg PATH-wSP group post-Vaccination 2. When comparing the PATH-wSP doses in toddler subjects, the proportion of seroresponders showed variable results based on the specific pneumococcal proteins. Taken together, the results do not suggest a dose-dependent immune response to pneumococcal antigens. It is noteworthy, however, that most subjects had measurable levels of </div>\n <div>\n antibodies against all the proteins tested, likely due to prior priming with S. pneumococcus. The expected high rates of pneumococcal colonization in this adult and toddler population may have blunted the immune response to PATH-wSP, as has been observed with pneumococcal conjugate vaccine. </div>\n <div>\n Any hypo-responsiveness effect of colonization would likely be reduced in the target infant population, given the lower prevalence of pneumococcal carriage.</div>\n <div>\n  </div>\n <div>\n PATH-wSP was well tolerated by both adults and toddlers and induced an appropriate immune response as assessed during this study. However, given the possible role of PATH-wSP in contributing to an increased relative risk of LRTI in toddlers during the peak RSV season and the uncertainty that vaccination was affording benefit, the Sponsor concluded that additional evidence of benefit exceeding risk must be generated in another (larger) clinical trial enrolling toddlers age 12 months and greater before conducting studies in the target population of infants age 6-8 weeks of age. Given this change to the development plan, the institution financing the vaccine’s development decided to end their support.</div>\n <div>\n  </div>\n <div>\n Date of Report: 14 December 2018</div>\n <div>\n  </div>\n <div>\n  </div>\n </div>\n <div>\n  </div>\n</div>\n<div>\n  </div>\n
      • implication_results(null)
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      • modified2019-02-13 16:21:13
      • created2015-08-31 14:08:49
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    • InvestigatorContact(array)
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        • id284
        • application_id416
        • given_nameJohn Anthony
        • middle_nameGerard
        • family_nameScott
        • qualificationBM BCh, MSc
        • professional_addressKEMRI-Wellcome Trust Research Programme, PO Box 230, Kilifi 80108, Kenya
        • telephone+254 705 412719
        • emailascott@ikilifi.org
        • created2015-08-31 14:09:50
        • modified2015-11-13 22:46:11
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        • created2015-08-31 14:09:50
        • modified2015-11-13 22:46:11
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id221
        • application_id416
        • sponsorPATH Vaccine Solutions
        • sponsor_type(null)
        • contact_personDr. Steve Lamola
        • address2201 Westlake Avenue, Suite 200 Seattle, WA 98121; USA
        • telephone_number(+1) 206-302-4669
        • fax_number
        • cell_number(+1) 206-302-4669
        • email_addressslamola@path.org
        • created2015-08-31 14:09:50
        • modified2015-11-13 22:46:11
  • 1(array)
    • Application(array)
      • id413
      • user_id63
      • trial_status_id6
      • abstract_of_study<p>\n Background: Tuberculosis (TB) is one of the most important global health problems. According to recent estimates from the World Health Organization (WHO), 8.6 million new cases and 1.3 million deaths from TB occurred in 2012.  The vast majority of TB cases and TB deaths are in developing countries. The spread of HIV has fuelled the TB epidemic, and TB is the leading cause of death among patients infected with HIV. The national case notification rate is 283/100000, whilst in KisumuCounty, the rate is 317 /100 000.TB treatment takes 6 months in Kenya and this relatively long treatment is associated with high relapse rates, relatively poor compliance than if the regimen were shorter. It is essential to shorten the treatment further, with efficacy proven in the new regimen. Treatment adherence is critical in TB treatment success and a shorter regimen may improve adherence. This study aims to find out the safety, tolerability and efficacy of 2 treatment regimens versus the standard drug susceptible TB treatment regimen currently used in Kenya. This, multicentre, randomized, controlled, open-label, (3-arm, phase 3 non-inferiority) clinical trial will enrol smear positive participants in Kisumu County. They will be randomized into either of the following 3 treatment arms; 2 RHZE/4HR for 26 weeks, 2PHZE/4PH for 17 weeks, 2PHZM/4PHM for 17 weeks. A shorter, more tolerable, efficacious treatment regimen will lead to better compliance, reduce pill burden and drug toxicity whilst improving TB treatment outcomes. </p>\n
      • study_title<p>\n  <span style=\"font-size: 12px;\">Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: a randomized, open-label, controlled, phase 3 clinical trial</span></p>\n
      • laymans_summary<div>\n This stud is a Rifapentine-Containing Treatment shortening regimens for pulmonary tuberculosis, A randomized, open-label, controlled phase 3 clinical trial in</div>\n<div>\n Kisumu County. It is an international, multicenter, randomized, controlled, open-label, 3-arm, phase 3 noninferiority trial. This study will be conducted in various TBTC and ACTG sites across the world In Kenya it will be conducted at the KEMRI/CDC clinical research center at the Jaramogi Oginga Odinga Teaching and referral hospital.</div>\n
      • short_titleRifapentine During Intensive Phase TB Treatment
      • protocol_noECCT/15/08/01
      • version_no1.1
      • date_of_protocol24-11-2014
      • study_drugRifapentine
      • disease_conditionTB
      • 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_nameRifapentine
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressEokeyo@kemricdc.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_data0
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi0
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr Elisha Okeyo
      • declaration_date108-08-2015
      • declaration_principal_investigatorDr Kevin P Cain
      • declaration_date208-08-2015
      • placebo_presentNo
      • study_objectives<div>\n PRIMARY OBJECTIVES:</div>\n<div>\n ï‚· To evaluate the efficacy of a rifapentine-containing regimen to determine whether the single</div>\n<div>\n substitution of rifapentine for rifampin makes it possible to reduce to seventeen weeks the</div>\n<div>\n duration of treatment for drug-susceptible pulmonary tuberculosis</div>\n<div>\n ï‚· To evaluate the efficacy of a rifapentine-containing regimen that in addition substitutes</div>\n<div>\n moxifloxacin for ethambutol and continues moxifloxacin during the continuation phase, to</div>\n<div>\n determine whether it is possible to reduce to seventeen weeks the duration of treatment for</div>\n<div>\n drug-susceptible pulmonary tuberculosis</div>\n<div>\n  </div>\n<div>\n Secondary Objectives</div>\n<div>\n ï‚· To evaluate the safety of the investigational regimens</div>\n<div>\n ï‚· To evaluate the tolerability of the investigational regimens</div>\n<div>\n ï‚· To collect and assess biospecimens from consenting participants for the purpose of</div>\n<div>\n research on discovery and validation of TB biomarkers</div>\n<div>\n ï‚· To determine the correlation of mycobacterial and clinical markers with time to culture</div>\n<div>\n conversion, culture status at completion of eight weeks of treatment, treatment failure,</div>\n<div>\n and relapse.</div>\n<div>\n ï‚· To conduct a pharmacokinetic/pharmacodynamic (PK/PD) study of the test drugs. The</div>\n<div>\n main objectives of the PK/PD study are to characterize study drug PK parameters and</div>\n<div>\n to determine relationships between treatment outcomes and PK parameters.</div>\n<div>\n ï‚· To evaluate the pharmacokinetics of efavirenz-based antiretroviral treatment among</div>\n<div>\n patients with TB/HIV co-infection taking efavirenz-based combination antiretroviral</div>\n<div>\n therapy and TB treatment with rifapentine</div>\n
      • principal_inclusion_criteria<h2>\n <strong>  </strong><strong>Inclusion Criteria</strong><strong>:</strong></h2>\n<p>\n Individuals must meet all of the following inclusion criteria in order to participate in this study:</p>\n<p style=\"margin-left:.75in;\">\n 1)      Suspected pulmonary tuberculosis plus one or both of the following: a) at least one sputum specimen positive for acid-fast bacilli on smear microscopy OR b) at least one sputum specimen positive for <em>M. tuberculosis</em> by Xpert MTB/RIF testing, with semi quantitative result of ‘medium’ or ‘high’ and rifamycin resistance not detected. </p>\n<p style=\"margin-left:.75in;\">\n 2)      Age twelve (12) years or older</p>\n<p style=\"margin-left:.75in;\">\n 3)      A verifiable address or residence location that is readily accessible for visiting, and willingness to inform the study team of any change of address during the treatment and follow-up period.</p>\n<p>\n 4)      Women of child-bearing potential who are not surgically sterilized must agree to practice a barrier method of contraception or abstain from heterosexual intercourse during study drug treatment.</p>\n<p>\n 5)      Documentation of HIV infection status.</p>\n<p>\n 6)      For HIV-positive individuals, CD4 T cell count greater than or equal to 100 cells/mm³ based on testing performed at or within 30 days prior to screening.</p>\n<p>\n 7)      Laboratory parameters done at or within 14 days prior to screening:</p>\n<p style=\"margin-left:1.5in;\">\n ·                     Serum or plasma alanine aminotransferase (ALT) less than or equal to 3 times the upper limit of normal</p>\n<p style=\"margin-left:1.5in;\">\n ·                     Serum or plasma total bilirubin less than or equal to 2.5 times the upper limit of normal</p>\n<p style=\"margin-left:1.5in;\">\n ·                     Serum or plasma creatinine level less than or equal to 2 times the upper limit of normal</p>\n<p style=\"margin-left:1.5in;\">\n ·                     Serum or plasma potassium level greater than or equal to 3.5 meq/L</p>\n<p style=\"margin-left:1.5in;\">\n ·                     Hemoglobin level of 7.0 g/dL or greater</p>\n<p style=\"margin-left:1.5in;\">\n ·                     Platelet count of 100,000/mm³or greater</p>\n<p style=\"margin-left:.75in;\">\n 8)      For women of childbearing potential, a negative pregnancy test at or within seven (7) days prior to screening.</p>\n<p style=\"margin-left:.75in;\">\n 9)      Karnofsky score greater than or equal to 60</p>\n<p>\n 10)  Written informed consent</p>\n<p>\n The study will provide study participants with counselling on the importance of contraception. Participants will be provided for with condoms and those who need other forms of barrier contraception will be referred to the appropriate care givers prior to starting study treatment.</p>\n<h2>\n  </h2>\n
      • principal_exclusion_criteria<h2>\n <strong> </strong><strong>E</strong><strong>xclusion Criteria</strong><strong>:</strong></h2>\n<p style=\"font-size: 11.9999990463257px;\">\n 1)      Pregnant or breast-feeding</p>\n<p style=\"font-size: 11.9999990463257px;\">\n 2)      Unable to take oral medications</p>\n<p style=\"font-size: 11.9999990463257px;\">\n 3)      Previously enrolled in this study</p>\n<p style=\"font-size: 11.9999990463257px;\">\n 4)      Received any investigational drug in the past 3 months</p>\n<p style=\"font-size: 11.9999990463257px;\">\n More than five (5) days of treatment directed against active tuberculosis within 6 months preceding initiation of study drugs</p>\n<p style=\"font-size: 11.9999990463257px; margin-left: 0.75in;\">\n 5)      More than five (5) days of systemic treatment with any one or more of the following drugs within 30 days preceding initiation of study drugs: isoniazid, rifampin, rifabutin, rifapentine, ethambutol, pyrazinamide, kanamycin, amikacin, streptomycin, capreomycin, moxifloxacin, levofloxacin, gatifloxacin, ofloxacin, ciprofloxacin, other fluoroquinolones, ethionamide, prothionamide, cycloserine, terizidone, para-aminosalicylic acid, linezolid, clofazimine, delamanid or bedaquiline</p>\n<p style=\"font-size: 11.9999990463257px; margin-left: 0.75in;\">\n 6)      Known history of prolonged QT syndrome. Site clinicians will assess participants and if there are signs and symptoms of heart disease or suggesting arrhythmias, then the clinician will request for  an ECG to rule out prolonged QT syndrome.</p>\n<p style=\"font-size: 11.9999990463257px; margin-left: 0.75in;\">\n 7)      Suspected or documented tuberculosis involving the central nervous system and/or bones and/or joints, and/or miliary tuberculosis and/or pericardial tuberculosis</p>\n<p style=\"font-size: 11.9999990463257px; margin-left: 0.75in;\">\n 8)      Current or planned use within six months following enrollment of one or more of the following medications: HIV protease inhibitors, HIV integrase inhibitors, HIV entry and fusion inhibitors, HIV non-nucleoside reverse transcriptase inhibitors other than efavirenz, quinidine, procainamide, amiodarone, sotalol, disopyramide, ziprasidone, or terfenadine. Individuals who are currently taking efavirenz-based antiretroviral treatment or for whom initiation of efavirenz-based antiretroviral treatment is planned within 17 weeks following enrollment may participate, as per Section 8.3.10. </p>\n<p style=\"font-size: 11.9999990463257px; margin-left: 0.75in;\">\n 9)      Weight less than 40.0 kg</p>\n<p style=\"font-size: 11.9999990463257px; margin-left: 0.75in;\">\n 10)  Known allergy or intolerance to any of the study medications</p>\n<p style=\"font-size: 11.9999990463257px; margin-left: 0.75in;\">\n 11)  Individuals will be excluded from enrollment if, at the time of enrollment, their <em>M. tuberculosis</em> isolate is already known to be resistant to any one or more of the following:  rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones.</p>\n<p style=\"font-size: 11.9999990463257px; margin-left: 0.75in;\">\n 12)  Other medical conditions, that, in the investigator’s judgment, make study participation not in the individual’s best interest.</p>\n<p style=\"font-size: 11.9999990463257px; margin-left: 0.75in;\">\n 13)  Current or planned incarceration or other involuntary detention.</p>\n<h2>\n  </h2>\n<p style=\"font-size: 11.9999990463257px;\">\n For minors, less than 18 years of age who are found to be pregnant, then the results of the pregnancy test shall be discussed with the minor as well as the parent. For those minors who already have children, the will be considered as mature minors and the parents will not have to be informed of the results.</p>\n
      • primary_end_points<p>\n <strong>Primary outcome Measure</strong></p>\n<p>\n Proportion of participants with grade 3 or higher adverse events during study drug treatment</p>\n<h3>\n secondary outcome measure</h3>\n<p>\n Discontinuation of assigned treatment for a reason other than microbiological ineligibility</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n STAFF IN THIS STUDY: 3 MEDICAL DOCTORS, 2 PHARMACISTS, 3 FULL-TIME NURSES, 1 PART TIME NURSE, 1 CO-ORDINATOR, 2 COMMUNITY MOBILISATION OFFICER, 1 QA MANAGER,1 OFFICERS, 1 QC OFFICER, 1 DATA MANAGER, 1 DATA OFFICER, 1 DATA SPECIALIST.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n SITE FACILITIES: CLINICAL TRIALS PHARMACY, BIO-SAFETY LEVEL 2 AND 3 TB LABORATORIES, LABORATORY FOR SAFETY PROFILE, ARRANGEMENT FOR IN AND OUT-PATIENT FACILITIES AT NEW NYANZA PROVINCIAL GENERAL HOSPITAL</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n  </p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n  </p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <u><strong>Profiles of key staff in TB Branch at KEMRI/CDC:</strong></u></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <u><strong>Dr Elisha Okeyo</strong></u></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <u><strong>Position Principal Investigator</strong></u></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <span style=\"color: rgb(34, 34, 34); font-family: Arial, Verdana, sans-serif; font-size: 12px;\">Dr Elisha currently holds a degree in Medicine.  Prior to joining KEMRICDC, Dr Elisha worked as a resident Medical Officer – Aga khan Hospital Kisumu from  2008 – 2010.  He then joined KEMRICDC as a Junior Investigator TBTC, KEMRI/CDC TB Research Branch       from 2011- 2013. He has been the  study Coordinator TBTC study 29X “Evaluation of a Rifapentine containing regimen for Intensive phase treatment of Pulmonary Tuberculosis in Adults in Kisumu County” and  Co-PI TBTC study 36” Platform for assessment of TB treatment outcomes in Kisumu County”.  Currently he is Co-PI A5279 “phase III clinical trial of ultra-short-course rifapentine/isoniazid for prevention of active tuberculosis in HIV infected individuals with latent tuberculosis infection” He is also a member of Kenya medical Association and Kenya medical Practioners and Dentists board</span></p>\n<p>\n <u>Dr Samuel Gurrion Ouma Ngaywa</u></p>\n<p>\n Position Coordinating PI</p>\n<p>\n Dr OUma is a Medical Doctor and Epidemiologist with 10 years clinical experience and 5 years clinical research experience. He has a Bachelors degree in Medicine and Bachelors degree in Surgery ( MbCHB)  from the University of Nairobi  and  a Masters in Public Health ( Epidemiology) – MPH from the University of Liverpool. He is a Principal investigator in 2 studies in KEMRI CGHR and a Co Investigator in numerous studies in KEMRI CGHR.</p>\n<p>\n His current responsibilities are : Administering protocol training to staff, leading studies as a Principal Investigator and Co Principal Investigator, supervising staff in a research setting and clinical setting, ensuring protocols are implemented in compliance with study protocol and regulatory ( local and International) requirements, triaging and managing study related medical emergencies, triaging and managing clinical trial participants  medical problems,  reading and interpreting chest x rays, source document development , development of site specific addenda for multicenter international protocols, safety reporting in clinical trials, SOP development, abstract and manuscript development and proposal writing. </p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <u>Dr. Kevin Cain</u></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <strong><u>Position: TB branch Chief</u></strong></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n Dr. Cain is the chief of the TB branch for KEMRI/CDC. Dr. Cain received his MD degree from the University of Pennsylvania School of Medicine in 2001. He then completed a 3 year residency training in internal medicine, is board certified in internal medicine, and is licensed in the state of Michigan. After completing internal medicine training in 2004, Dr. Cain joined CDC in Atlanta, where he completed 2 years of applied epidemiology training as an Epidemic Intelligence Service (EIS) officer with the International Research and Programs Branch of the Division of Tuberculosis Elimination. After completing EIS in 2006, he remained at CDC in the same branch. He became team lead for TB/HIV in 2008, and he was acting chief of the branch in late 2010 and early 2011 before accepting a position with CDC Kenya as the Chief of the TB Branch for KEMRI/CDC in Kisumu.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n  </p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n Dr. Cain has led a variety of epidemiologic studies during his time at CDC, including studies of TB among foreign-born persons in the United States and of TB screening and diagnosis in people with HIV. Dr. Cain has over 20 publications in peer-reviewed literature, including first-author publications in the New England Journal of Medicine and the Journal of the American Medical Association. He also has authored several editorial commentaries at the invitation of scientific journals, has given multiple presentations at international conferences, and has worked closely with World Health Organization on global and regional policy. He led the development of a revised framework for TB/HIV for WHO in the Western Pacific Region. Currently, he is the US representative to the technical advisory group for TB for WHO Western Pacific Region.</p>\n<p>\n Dr. Eunice Akinyi Ouma</p>\n<p>\n Position_co-investigator</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n Dr Eunice Ouma holds a bachelor’s degree in Medicine and Surgery (MBChB) from Moi University having graduated in the year 2010. Currently she works as an Assistance Research Officer with KEMRI-CGHR since July 2014. I. I have worked with the Ministry of Health as a Medical Officer prior to my current position. I currently work across various ACTG studies that are on going at our site and also in TBTC 36 AND 36A, in which I have gained a wealth of experience in both clinical and observational trials</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n  </p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <u>Lazarus Odeny</u></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <strong><u>Position: Senior Data Manager</u></strong></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n He holds the position of TB branch Senior Data Manager</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n He has over 10 years of data management, biostatistics and epidemiology experience. He is currently registered for a doctor of science in Epidemiology (PhD) at the Erasmus University in Rotterdam, Netherlands.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n He has held the following positions:</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n  </p>\n<p style=\"margin: 0px 0px 10px 0.25in; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n 1.    Senior Data Analyst and Data manager – <strong>KEMRI/CDC</strong></p>\n<p style=\"margin: 0px 0px 10px 0.25in; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n 2.    Senior Data manager – International Centre for Reproductive Health (<strong>ICRH</strong>)</p>\n<p style=\"margin: 0px 0px 10px 0.25in; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n 3.    Data manager – <strong>KEMRI/CDC</strong></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n He is proficient in SAS, SPSS, EPIINFO, STATA, Microsoft office 2003 suite (Word, Excel, PowerPoint, Access), VFP, Visual CE for PDA, Microsoft visual basic, DOTNET framework, S-Plus, C + +, SQL, ISA firewall server administrator and SQL servers. All large studies conducted by the TB branch in the past several years have utilized electronic data collection and management, and this process has been designed and managed by Lazarus.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n  </p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <u>Rose Abwunza</u></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <strong><u>Quality Assurance Manager</u></strong></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n  </p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n She holds the position of QA manager since 2015 in the TB research branch. She is a graduate of the University of Nairobi holding a <strong>Masters in Arts (project planning and management). </strong>She has been able to participate in the following studies: 2 regulated epidemiological studies i.e. Adolescent Cohort study (an epidemiological study on TB prevalence and Incidence in adolescents), Infant Cohort study (an epidemiological study investigating the incidence of TB in Infants), and a TB vaccine study, which is ongoing and other nested studies as a training education and communication coordinator.She currently holds the position of QA/Training manager.The QA duties include management of regulatory submissions, tracking of all annual approvals, management of the essential documents<strong>, </strong>safety and deviation tracking and reporting<strong>, </strong>quality control and verification of source documents and CRFs<strong>, </strong>preparation of study files for data collection<strong>, </strong>hosting monitoring and audit visits<strong>, </strong>corrective actions follow up and archiving of study documents .</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n She has gained relevant trainings and skills during her research experience which include:  Good Clinical Practice,  ethical aspects in clinical research, and epidemiology and biostatistics; all trainings were offered by the Vienna School of Clinical Research (VSCR). </p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n  </p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <u>Dr. Victor Mudhune</u></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <strong><u>Position: Clinical Trials Pharmacist</u></strong></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n  </p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n He holds the position of study pharmacist in the HIV research and TB branches and is the pharmacist for the TBTC drug trial. He previously worked as a hospital pharmacist.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n His major duties as a clinical trials pharmacist include:</p>\n<p style=\"margin: 0px 0px 10px 0.25in; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n 1.    Coordination of all issues related to study drug/placebo supply and preparing all doses for administration and dispensing by the nurses.</p>\n<p style=\"margin: 0px 0px 10px 0.25in; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n 2.    Maintaining appropriate records of the receipt and disposition of the study vaccine, placebos, benefit vaccine and inventory of all medicines.</p>\n<p style=\"margin: 0px 0px 10px 0.25in; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n 3.    Monitoring and documenting cold chain maintenance for all study vaccines to ensure quality of the products is not compromised.</p>\n<p style=\"margin: 0px 0px 10px 0.25in; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n 4.    Managing study participant randomization process and preparing the study vaccine/placebo doses for administration to study participants as per the study vaccine management manual.</p>\n<p style=\"margin: 0px 0px 10px 0.25in; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n 5.    Maintaining the blinding of the participant’s treatment assignment to investigators, study nurses, clinic staff and participant.</p>\n<p style=\"margin: 0px 0px 10px 0.25in; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n 6.    Maintaining the confidentiality of the participant, participant’s pharmacy file and the study drug/placebo accountability record.</p>\n<p style=\"margin: 0px 0px 10px 0.25in; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n 7.    Establishing a system to ensure that the participants sign an informed consent before dispensing the drugs and ensuring that the current IRB approved version of the protocol is adhered to in dispensing the drug/placebo.</p>\n<p style=\"margin: 0px 0px 10px 0.25in; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n 8.    Ensuring the security of all documents and investigational drug/placebo.</p>\n<p style=\"margin: 0px 0px 10px 0.25in; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n 9.    Preparing pharmacy related standard operating procedures ensuring they meet GCP, NIH and other regulatory requirements.</p>\n<p style=\"margin: 0px 0px 10px 0.25in; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n 10.  Following established departmental policies, procedures and objectives, continuous quality improvement objectives and safety, environmental and/or infection control standards.</p>\n<p style=\"margin: 0px 0px 10px 0.25in; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n 11.  Providing overall supervision to senior TB branch staff on pharmacy related activities.</p>\n<p style=\"margin: 0px 0px 10px 1in; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n  </p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n He has worked as a research pharmacist for the last 4.5 years as a research pharmacist and is trained in GCP, Human Subject Protection, NIH online training, and clinical trial management. He is currently training others in the same courses at the KEMRI/CDC field stations.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n  </p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n He has been involved in site preparations for the PAVE 100 trial, a DAIDS sponsored trial and in a completed study (the Kisumu Breastfeeding Study). He also functioned as backup pharmacist in a completed vaccine study (Rotavirus Vaccine Study).</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n He is the clinical trial pharmacist for the HPTN 052, a DAIDS sponsored trial, and the pharmacist to:  Aeras 402 vaccine trial (TB vaccine study), the TBTC drug trial and GSK MAL055/058 Vaccine trial.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n  </p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <u>Albert Ochieng Okumu</u></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <strong><u>Position: Laboratory Manager</u></strong></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n He holds the position of Laboratory Manager for the KEMRI/CDC, TB laboratory at the Kisian field station. His focus is on the quality and excellent performance of the KEMRI/CDC TB research laboratory. He has been able to receive into this laboratory study monitors, lab assessment visitors and auditors conducting assessments of the TB clinical trials at the site.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n He has received and also coordinated trainings in: Good Clinical Laboratory Practice, participation in external quality assessment programmes and developed in house Quality Control systems.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n He has worked previously with government health facilities in Kenya in different capacities, such as a laboratory technologist, government health facility laboratory in-charge and government laboratories district in-charge. His work with the Ministry of Health gave him experience in routine laboratory tests and procedures, laboratory diagnostics including in patients with TB and HIV of all ages.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n His initial research experience was at the Kenya Medical Research Institute, Centre for Microbiology Research, Kisumu, in an ‘Investigational New Drug’ HIV trial sponsored by the Gates foundation. This study was conducted for five years and it was implemented by Partners in Prevention (University of Washington). In his role in the study he was able to establish a functional clinical research laboratory. He also supported various sub- studies that conducted several laboratory assays for participants in microbicide studies such as: Female ViVaGel-USA, IPM (International partnerships for microbicides) of South Africa.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n He has received trainings and skills in Good Clinical Laboratory Practice (GCLP) and Ethics (IAVI and Vienna School of Clinical Research), International shipping regulations (IATA, Mayo) and he has coordinated trainings in: GCLP, participation in external quality assessment programs and developed in-house Quality Control systems.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n  </p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <u>Benard Owuor</u></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <strong><u>Position: TB branch Administrative Manager</u></strong></p>\n<p align=\"left\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n He holds the position of TB branch Administrative Manager. His qualifications include: MBA (finance), BBA (Accounting), CPA and Diploma in information technology and computer sciences.</p>\n<p align=\"left\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n His work experience in accounting, auditing and management covers 10 years at KEMRI/CDC and at 2 educational institutions. He also has 6 years experience as an administrator where he has been able to demonstrate: good leadership, organisational management, team-building skills, flexibility and strong communication skills.</p>\n<p align=\"left\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n In his capacity as administrative manager in the TB research branch, KEMRI/CDC he has been able to oversee financial management, organisational management and administrative tasks for several TB branch research studies, managing budgets of millions of dollars, and handling all reporting and auditing requirements for sponsors.</p>\n
      • other_details_explanation<p>\n The trial is to be conducted in the host country of the applicant</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n KEMRI Scientific Ethics Review Unit Approval date 21 Jul 2015</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration3 years
      • 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_comparator2RHZE/4RH
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRICDC, KISUMU, KENYA
      • single_site_physical_addressALONG KISUMU-KAKAMEGA ROAD AT JOOTRH, CDC CLINICAL RESEARCH CENTRE
      • single_site_contact_personELISHA OKEYO
      • single_site_telephone0721410654
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_statesover 8
      • number_of_sites
      • multi_country_listUSA,Spain,South Africa,Hong Kong,Kenya,Vietnam,Peru,Uganda, various Aids Clinical Trials Groug (ACTG) sites
      • data_monitoring_committeeYes
      • total_enrolment_per_siteno minimum or maximum number
      • total_participants_worldwide2500
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameSamuel
      • investigator1_middle_nameGurrion
      • investigator1_family_nameOuma
      • investigator1_qualificationMedical Doctor
      • investigator1_professional_addressP.O Box 1578, 40100 Kisumu
      • investigator1_telephone057-2022902/59/02
      • investigator1_emailSouma@kemricdc.org
      • organisations_transferred_Yes
      • number_participants50-100
      • notification
      • approval_date05-05-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted26-03-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2020-03-26 10:33:24
      • created2015-08-06 14:38:00
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id281
        • application_id413
        • given_nameElisha
        • middle_nameOchieng
        • family_nameOkeyo
        • qualificationMedical Doctor
        • professional_addressP.O Box 1578, 40100 Kisumu
        • telephone057-2022902/59/02
        • emailEokeyo@kemricdc.org
        • created2015-08-06 15:34:58
        • modified2020-03-26 10:33:24
    • SiteDetail(array)
      • 0(array)
        • id334
        • application_id413
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-08-06 15:34:58
        • modified2020-03-26 10:33:24
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id219
        • application_id413
        • sponsorCDC, NIH
        • sponsor_typeResearch Institution
        • contact_personStefan Goldberg, M.D.
        • address1600 Clifton Road, MS E-10 Atlanta, GA, USA 30333
        • telephone_number404-639-5339
        • fax_number
        • cell_number404-639-5339
        • email_addressssg3@cdc.gov
        • created2015-08-06 15:34:58
        • modified2020-03-26 10:33:24
  • 2(array)
    • Application(array)
      • id412
      • user_id73
      • trial_status_id5
      • abstract_of_study<p>\n The greatest burden of the HIV-1 epidemic lies in sub-Saharan Africa, where a substantial proportion of infections occur in long-term HIV-1 serodiscordant partnerships, i.e. where one partner is HIV-1 infected and the other uninfected. Heterosexual HIV-1 serodiscordant couples face a difficult dilemma when considering their desire to have children: forego condom use, attempt to conceive and risk HIV-1 transmission or continue condom use and relinquish their childbearing desires. Pregnancy rates among HIV-1 serodiscordant couples are similar to the general population and we have learned from our clinical trial cohorts and qualitative data collection that fertility desires often outweigh HIV-1 risks for these couples and they make conscientious decisions to increase sexual frequency and reduce condom use in order to conceive. Thus, there is a critical need to test the feasibility and acceptance of a “safer conception” intervention for low resource settings, an integrated biomedical and behavioral approach to minimize HIV-1 risk when serodiscordant couples are intending to become pregnant. In the absence of such an intervention, couples will continue to attempt pregnancy, but they will do so with greater HIV-1 transmission risk than necessary.</p>\n<p>\n Based on evidence from rigorous clinical trials demonstrating the strong efficacy of individual interventions  for HIV-1 prevention and formative work with HIV-1 serodiscordant couples and clinicians with expertise in HIV-1 prevention and reproductive health in the Kenyan context, we will pilot a safer conception intervention that focuses on antiretrovirals (as antiretroviral therapy [ART] taken by the HIV-1 infected partner and pre-exposure prophylaxis [PrEP] taken by the HIV-1 uninfected partner) and timed condomless sex.  Additional strategies for couples will include diagnosis and treatment of STIs and male circumcision. The Figure below presents a schematic of the safer conception components that will be incorporated.</p>\n<p>\n mHealth tools, including SMS and tablet applications, are novel and very popular among Kenyans to ease the burden of addressing health problems.  Our safer conception intervention will incorporate mHealth tools to improve couples’ experiences tracking fertility indicators and communicating with providers about their readiness to practice safer conception.  An SMS survey will be used to collect daily information from women about their fertility signs and SMS messages will be used to reinforce HIV-1 prevention, including condom use for couples during periods that do not have a high likelihood of fertility. An in-clinic tablet application will be used to improve clinician-patient counseling and assessments of couple readiness to practice safer conception. To inform future engagement of mHealth tools, will prospectively evaluate clinician and patient experiences using SMS surveys and the tablet application.</p>\n<p>\n This work will take place at the Partners in Health Research and Development site in Thika, Kenya, where the clinical research staff are experts in working with HIV-1 serodiscordant couples since the site inception in 2006.  Couples with immediate fertility intentions and a high likelihood to become pregnant within one year – determined by using a validated, empiric scoring tool that we have developed – will be followed longitudinally, allowing careful tracking of pregnancy and HIV-1 incidence.  This is the exact outcome that HIV-1 prevention programs need to monitor to ensure that we fully understand the preferences and willingness of couples to practice safer conception and the ability of an integrated intervention to reduce HIV-1 transmission risk to the lowest level possible during peri-conception periods.</p>\n<p>\n  </p>\n
      • study_title<p align=\"center\">\n <strong>Pilot of an mHealth-enhanced, safer conception intervention to reduce HIV-1 risk among Kenyan HIV-1 serodiscordant couples</strong></p>\n<p align=\"center\">\n <strong><em>Safer Conception Intervention for Partners (SCIP)</em></strong></p>\n
      • laymans_summary(null)
      • short_titleSafer Conception Intervention for Partners (SCIP)
      • protocol_noECCT/15/10/03
      • version_no3.0
      • date_of_protocol08-09-2015
      • study_drugEmtricitabine/Tenofovir or Tenofovir Disoproxil Fumarate (SCIP Study)
      • disease_conditionPrEP as a \'\'Safer Conception Tool\'\'
      • 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_nameEmtricitabine/Tenofovir or Tenofovir Disoproxil Fumarate
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressRwamba@csrtkenya.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. Kenneth Ngure
      • declaration_date122-10-2015
      • declaration_principal_investigatorDr. Nelly Rwamba Mugo
      • declaration_date222-10-2015
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p style=\"margin-left:1.0in;\">\n <u>For couples</u></p>\n<ul>\n <li>\n Immediate fertility intention and a high likelihood of pregnancy</li>\n <li>\n Sexually active (defined as having had vaginal intercourse at least 6 times in the previous three months)</li>\n <li>\n Willing to enter the study as a couple and intending to remain as a couple for the next 12 months</li>\n <li>\n Did not participate in the Partners PrEP Study or the Partners Demonstration Project</li>\n</ul>\n<p>\n <u>For HIV-1 infected members of the couple (index participants)</u></p>\n<ul>\n <li>\n Age ≥18</li>\n <li>\n If female, not older than age 49</li>\n <li>\n Able and willing to provide written informed consent</li>\n <li>\n HIV-1 infected based on positive rapid HIV-1 tests, according to national algorithm</li>\n <li>\n Not currently pregnant or breastfeeding</li>\n <li>\n No use of injectable contraception for the past 3 months</li>\n <li>\n Not currently enrolled in an HIV-1 treatment study</li>\n <li>\n No clear indication of infertility or subfertility, as determined by medical history</li>\n <li>\n Own a mobile phone for personal use, which operates on a telecom provider supported by the study SMS platform and is distinct from the mobile phone owned by the HIV-1 uninfected partner</li>\n <li>\n Know how to send and receive SMS</li>\n <li>\n Have regular access to electricity or an alternative means for charging a cell phone</li>\n <li>\n Literate in English, Kiswahili or Kikuyu</li>\n</ul>\n<p>\n <u>For HIV-1 uninfected members of the couple (partner participants)</u></p>\n<ul>\n <li>\n Age ≥18</li>\n <li>\n If female, not older than age 49</li>\n <li>\n Able and willing to provide written informed consent</li>\n <li>\n HIV-1 uninfected based on negative HIV-1 rapid tests, both at study screening and at the enrollment visit</li>\n <li>\n Adequate renal function, defined by normal creatinine levels and estimated creatinine clearance ≥60 mL/min</li>\n <li>\n Not infected with hepatitis B virus, as determined by a negative hepatitis B surface antigen test</li>\n <li>\n Not currently pregnant or breastfeeding  </li>\n <li>\n No use of injectable contraception for the past 3 months</li>\n <li>\n Not currently enrolled in an HIV-1 prevention clinical trial</li>\n <li>\n Enrollment of individuals with active and serious infections or active clinically significant medical problems will be at the discretion of the site investigator</li>\n <li>\n No clear indication of infertility or subfertility, as determined by medical history</li>\n <li>\n Own a mobile phone for personal use, which operates on a telecom provider supported by the study SMS platform and is distinct from the mobile phone owned by the HIV-1 infected partner</li>\n <li>\n Know how to send and receive SMS</li>\n <li>\n Have regular access to electricity or an alternative means for charging a cell phone</li>\n <li>\n Literate in English, Kiswahili or Kikuyu</li>\n</ul>\n<p>\n <u>For study clinicians and counselors</u></p>\n<ul>\n <li>\n Active involvement in safer conception counseling for couples and use of the tablet application during counseling sessions</li>\n</ul>\n
      • principal_exclusion_criteria<p>\n Contrary to any of the Inclusion criteria.</p>\n<p>\n Having taken part in Partners PrEP Study or the Partners Demonstration Project.</p>\n
      • primary_end_points<p>\n Pregnancy using the safer conception tools.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy1
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Thika partners in Prevention, Site has 32 full time clinical trial staff (including physicians, nurses, counsellors, pharmacists).</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Principal Investigator: Dr. Nelly R. Mugo  MBChB,MMED,MPH</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Site Coordinator: Dr. Kenneth Ngure  BSc,MPH,MSc,PhD</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Lead Physician for the study: Dr. Njambi Njuguna  MBChB, MSc, MPH</p>\n
      • other_details_explanation<p>\n The greatest burden of the HIV-1 epidemic lies in sub-Saharan Africa, where a substantial proportion of infections occur in long-term HIV-1 serodiscordant partnerships, i.e. where one partner is HIV-1 infected and the other uninfected. Heterosexual HIV-1 serodiscordant couples face a difficult dilemma when considering their desire to have children: forego condom use, attempt to conceive and risk HIV-1 transmission or continue condom use and relinquish their childbearing desires. Pregnancy rates among HIV-1 serodiscordant couples are similar to the general population and we have learned from our clinical trial cohorts and qualitative data collection that fertility desires often outweigh HIV-1 risks for these couples and they make conscientious decisions to increase sexual frequency and reduce condom use in order to conceive. Thus, there is a critical need to test the feasibility and acceptance of a “safer conception” intervention for low resource settings, an integrated biomedical and behavioral approach to minimize HIV-1 risk when serodiscordant couples are intending to become pregnant. In the absence of such an intervention, couples will continue to attempt pregnancy, but they will do so with greater HIV-1 transmission risk than necessary.</p>\n
      • other_details_regulatory_notapproved<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n University of Washington Institutional Review Board (UW IRB)</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n Submission will be done before end of October 2015</p>\n
      • other_details_regulatory_approved<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n Kenya Medical Research Institute's (KEMRI) Scientific, Ethics and Research Unit (SERU)</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n                     Approved on 5th October 2015.</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration3 Years
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaThika Partners Study Clinic (Partners in Health Research and Development) affiliated to the University of Washington International Clinical Research Center (ICRC), and KEMRI
      • single_site_physical_addressOAU Road, Near Thika Nursing home - Thika section 9
      • single_site_contact_personDr. Kenneth Ngure
      • single_site_telephone067-22561
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site80 couples\nStudy clinicians and counselors delivering the intervention
      • total_participants_worldwide80 couples, Study clinicians and counselors delivering the intervention
      • 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_nameRenee
      • investigator1_middle_name
      • investigator1_family_nameHeffron
      • investigator1_qualificationMPH, PhD
      • investigator1_professional_addressUniversity of Washington, Seattle
      • investigator1_telephone+1 2065203817
      • investigator1_emailrheffron@uw.edu
      • organisations_transferred_Yes
      • number_participants80 couples\nStudy clinicians and counselors delivering the intervention
      • notification
      • approval_date11-01-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted22-10-2015
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2018-08-02 11:46:04
      • created2015-08-06 11:19:28
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id280
        • application_id412
        • given_nameNelly
        • middle_nameRwamba
        • family_nameMugo
        • qualificationMBChB, MPH
        • professional_addressUNITID Building, Box 19865-00202, KNH, Nairobi
        • telephone0723 914057
        • emailrwamba@csrtkenya.org
        • created2015-08-06 11:20:52
        • modified2015-10-22 10:45:47
    • SiteDetail(array)
      • 0(array)
        • id333
        • application_id412
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-08-06 11:20:52
        • modified2015-10-22 10:45:47
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id218
        • application_id412
        • sponsorUniversity of Washington
        • sponsor_type(null)
        • contact_personDr. Nelly Rwamba Mugo
        • addressUNITID Building, Box 19865-00202, KNH, Nairobi
        • telephone_number067-22561
        • fax_number
        • cell_number0723 914057
        • email_addressrwamba@csrtkenya.org
        • created2015-08-06 11:20:52
        • modified2015-10-22 10:45:47
  • 3(array)
    • Application(array)
      • id409
      • user_id73
      • trial_status_id5
      • abstract_of_study<p style=\"text-align: justify;\">\n Our objective is to study effects of a contraceptive vaginal ring (CVR) containing estrogen and progesterone (NuvaRing) on vaginal bacteria, HIV shedding, and local immunity in women. We will build on data that support a favorable effect of CVR on vaginal bacteria. Bacterial vaginosis (BV) is found in <u>></u>50% of women in sub-Saharan Africa. BV significantly increases risk of HIV acquisition in, and HIV transmission to male partners from, HIV-infected women, genital HIV shedding, and viral set point in infected male partners. Pregnancy is also an independent risk for HIV acquisition and transmission. Contraception comprises critical biomedical prevention for women with or at risk for HIV. Systemic depot progesterone—commonly used throughout Africa—may independently increase risk of HIV acquisition and transmission. Hormonal interventions preventing unintended pregnancy and promoting a protective vaginal microenvironment could synergistically reduce HIV risk especially combined with topical antiretrovirals (ARV). We hypothesize NuvaRing use may contribute to reduction in BV, pregnancy prevention, and decreased rates of HIV shedding in HIV-infected women. <u>Sustained vaginal delivery of contraceptive and ARV PrEP as “multicomponent prevention” is a major focus for scientists but effects on the vaginal environment need careful definition before broad implementation</u>.</p>\n<p style=\"text-align: justify;\">\n <strong>Aim 1: Determine effect of CVR on vaginal bacteria, including incident/persistent BV. </strong>Show whether sustained local hormone delivery promotes desirable lactobacilli, and thus reduces risk of BV, in women with and without HIV.</p>\n<p style=\"text-align: justify;\">\n <strong>Aim 2. Define the soluble mucosal host immune response and endocervical immune cell populations with CVR. </strong>Determine if shifts in vaginal bacteria anticipated to occur with CVR will be accompanied by favorable changes in the lower genital tract, including restoration of protective mediators decreased with BV.</p>\n<p style=\"text-align: justify;\">\n <strong>Aim 3. In HIV-infected women, determine effect of CVR on genital HIV shedding. </strong>HIV-infected women not on ART at enrollment will have endocervical swabs collected for HIV RNA quantification.</p>\n<p style=\"text-align: justify;\">\n <strong>Study Site and Population</strong></p>\n<p style=\"text-align: justify;\">\n This study will be conducted at the Thika Partners Study Clinic located in Thika, Kenya. We will enroll approximately 120 women with bacterial vaginosis (BV) based on clinical criteria and a minimum of 75 male sex partners.</p>\n
      • study_title<p align=\"center\">\n <strong>Effects of contraceptive ring on vaginal microbiota, HIV shedding and local immunity</strong></p>\n
      • laymans_summary<p>\n The need for contraceptive options in women at risk for HIV acquisition has taken on urgency with evidence indicating that systemic hormonal contraception (primarily injectable, long-acting progestin) may increase women’s risk of HIV acquisition and transmission to male sex partners.<a href=\"#_ENREF_1\" title=\"Polis, 2013 #1991\">¹</a> Lack of other contraceptive options, especially for women at highest risk of HIV in Sub-Saharan Africa, is a critical barrier to progress towards optimizing women’s reproductive health. While intrauterine devices (IUDs) are an option, implementation of delivery has been slow. The use of a contraceptive vaginal ring (CVR) has been explored and reported on in several Sub-Saharan African countries, and its acceptability in general is excellent.<a href=\"#_ENREF_2\" title=\"van der Straten, 2012 #3050\">²</a> A commonly used CVR in the United States is the NuvaRing. Moreover, the format of drug delivery through the form of a vaginal ring is also being intensely explored with the use of antiretroviral agents (dapivirine, tenofovir) as a means of topical, female-controlled HIV prevention, and formulation work with several antiretroviral drugs for sustained delivery with the NuvaRing format is underway.<a href=\"#_ENREF_3\" title=\"Kiser, 2012 #3052\">³</a> Such “multicomponent prevention” has become a major focus for scientists, advocates, and funders alike.</p>\n<p>\n  </p>\n
      • short_titleNuvaRing Study
      • protocol_noECCT/15/09/01
      • version_no2.4
      • date_of_protocol23-06-2015
      • study_drugNuvaRing (Vaginal contraceptive ring)
      • disease_conditionVaginal Bacteria, HIV & Vaginal local Immunity
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device1
      • product_type_chemical_nameEstrogen & Progesterone
      • product_type_medical_device_nameContraceptive Vaginal Ring (NuvaRing)
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressRwamba@csrtkenya.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_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi0
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr. Kenneth Ngure
      • declaration_date102-09-2015
      • declaration_principal_investigatorDr. Nelly Rwamba Mugo
      • declaration_date202-09-2015
      • placebo_presentNo
      • study_objectives<p>\n <strong>Primary Objective:</strong></p>\n<p>\n To assess potential benefits associated with both cyclic (use for 3 weeks, remove for 1 week, as defined in the package insert) and continuous (use for 4 weeks, then replace) CVR use among women (both HIV-negative and HIV-positive) with BV at enrollment (and thus at high risk for BV persistence and recurrence).</p>\n<p>\n <strong>Secondary objectives: </strong></p>\n<ol style=\"list-style-type:lower-roman;\">\n <li>\n To determine the effect of the CVR on clinically defined incidence of BV, the vaginal microbiome and rates of adverse events with CVR use.</li>\n <li>\n To assess the acceptability of the CVR to men who are sex partners of study participants.</li>\n <li>\n To assess acceptability and preference for contraceptive type at study end.</li>\n</ol>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n <strong>Female Eligibility Criteria:</strong></p>\n<ul>\n <li>\n ≥18-40 year old BV+ by Amsel’s criteria</li>\n <li>\n Not intending or wishing to become pregnant over the course of the study</li>\n <li>\n Capable of providing written informed consent</li>\n</ul>\n<div>\n  </div>\n<p>\n <strong>Male Eligibility Criteria:</strong></p>\n<ul>\n <li>\n Main sex partner of randomized female participant</li>\n <li>\n Capable of providing written informed consent</li>\n</ul>\n
      • principal_exclusion_criteria<p>\n <strong>Female Exclusion Criteria:</strong></p>\n<ul>\n <li>\n Current pregnancy</li>\n <li>\n Desire/intent to become pregnant over the course of the study</li>\n <li>\n Current cigarette smoking if age is older than 35 years</li>\n <li>\n Unable to comprehend consent material because of language barrier or psychological difficulty</li>\n</ul>\n<p>\n <strong>Male Exclusion Criteria:</strong></p>\n<ul>\n <li>\n Unable to comprehend consent material because of language barrier or psychological difficulty</li>\n</ul>\n
      • primary_end_points<p style=\"margin-left:.5in;\">\n Outcome 1:  Quantity of <em>L. crispatus</em> determined by species-specific qPCR assay</p>\n<p style=\"margin-left:.5in;\">\n Outcome 2:  Local immune parameters, including cytokines, innate mediators, and functional antimicrobial activity in cervicovaginal secretions as assessed                        by anti-<em>E. coli</em>, anti-HSV, and anti-HIV activity</p>\n<p style=\"margin-left:.5in;\">\n Outcome 3:  Quantity of genital HIV shedding among HIV-infected participants </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Thika partners in Prevention, Site has 32 full time clinical trial staff (including physicians, nurses, counsellors, pharmacists).</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Principal Investigator: Dr. Nelly R. Mugo  MBChB,MMED,MPH</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Site Coordinator: Dr. Kenneth Ngure  BSc,MPH,MSc,PhD</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Lead Physician for the study: Dr. Elizabeth Irungu  MBChB</p>\n
      • other_details_explanation<p>\n The need for contraceptive options in women at risk for HIV acquisition has taken on urgency with evidence indicating that systemic hormonal contraception (primarily injectable, long-acting progestin) may increase women’s risk of HIV acquisition and transmission to male sex partners.Lack of other contraceptive options, especially for women at highest risk of HIV in Sub-Saharan Africa, is a critical barrier to progress towards optimizing women’s reproductive health. While intrauterine devices (IUDs) are an option, implementation of delivery has been slow. The use of a contraceptive vaginal ring (CVR) has been explored and reported on in several Sub-Saharan African countries, and its acceptability in general is excellent.<span style=\"font-size: 10px;\"> </span>A commonly used CVR in the United States is the NuvaRing. Moreover, the format of drug delivery through the form of a vaginal ring is also being intensely explored with the use of antiretroviral agents (dapivirine, tenofovir) as a means of topical, female-controlled HIV prevention, and formulation work with several antiretroviral drugs for sustained delivery with the NuvaRing format is underway.<span style=\"font-size: 10px;\"> </span>Such “multicomponent prevention” has become a major focus for scientists, advocates, and funders alike.</p>\n
      • other_details_regulatory_notapproved<p>\n University of Washington Institutional Review Board (UW IRB)</p>\n<p>\n Submission will be done before end of September 2015</p>\n
      • other_details_regulatory_approved<p>\n Kenya Medical Research Institute's (KEMRI) Scientific, Ethics and Research Unit (SERU)</p>\n<p>\n                     Approved on 20th July 2015.</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration5 years
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaThika Partners Study Clinic (Partners in Health Research and Development) affiliated to the University of Washington International Clinical Research Center (ICRC), and KEMRI
      • single_site_physical_addressOAU Road, Near Thika Nursing Home
      • single_site_contact_personDr. Kenneth Ngure
      • single_site_telephone067-2222561
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site195
      • total_participants_worldwide195
      • 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_nameJeanne
      • investigator1_middle_name
      • investigator1_family_nameMarrazzo
      • investigator1_qualificationProfessor of Medicine
      • investigator1_professional_addressUniversity of Washington, Seattle
      • investigator1_telephone+1-206-744-3679
      • investigator1_emailjmm2@u.washington.edu
      • organisations_transferred_Yes
      • number_participants120 women with bacterial vaginosis (BV) and a minimum of 75 male sex partners.
      • notification
      • approval_date16-02-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted09-06-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2020-06-15 11:42:25
      • created2015-07-28 16:22:20
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        • id279
        • application_id409
        • given_nameNelly
        • middle_nameRwamba
        • family_nameMugo
        • qualificationMBChB, MPH
        • professional_addressUNITID Building, Box 19865-00202, KNH, Nairobi
        • telephone0723 914057
        • emailrwamba@csrtkenya.org
        • created2015-08-03 13:46:45
        • modified2020-06-09 00:44:47
    • SiteDetail(array)
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        • application_id409
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        • site_name
        • physical_address
        • contact_details
        • contact_person
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        • misc(null)
        • created2015-08-03 13:46:45
        • modified2020-06-09 00:44:47
        • County(empty)
    • Sponsor(array)
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        • id217
        • application_id409
        • sponsorUniversity of Washington
        • sponsor_typeOthers
        • contact_personDr. Nelly Rwamba Mugo
        • addressUNITID Building, Box 19865-00202, KNH, Nairobi
        • telephone_number067 22561
        • fax_numbern/a
        • cell_number0723 914057
        • email_addressrwamba@csrtkenya.org
        • created2015-08-03 13:46:45
        • modified2020-06-09 00:44:47
  • 4(array)
    • Application(array)
      • id405
      • user_id38
      • trial_status_id8
      • abstract_of_study<p style=\"margin-left:.5in;\">\n The proposed research project will evaluate the effects of zinc supplementation in children with sickle cell disease (SCD) in western Kenya. Zinc is a nutritionally essential trace element found in previous studies to reduce growth retardation and improve immune function, which may also result in decreased incidence of infectious diseases including malaria, pneumonia and diarrhea. SCD patients are known to be susceptible to zinc deficiency and appear to benefit from zinc supplementation. Despite these findings, SCD patients in Kenya have not benefited from zinc supplementation programmes? due to a lack of research and findings to inform policy in the East African-setting. Specifically, the proposed pilot research project will: investigate the influence of zinc supplementation on incidence of malaria infections in children with SCD; investigate the influence of zinc supplementation on incidence of bacterial infections (e.g. <em>S pneumoniae</em>, <em>H influenzae</em> and non-typhi <em>Salmonella </em>species) in children with SCD and investigate the influence of zinc supplementation on morbidity in children with SCD in western Kenya. We will conduct a 6 month randomized controlled pilot trial involving children with SCD aged 6 months to less than 13 years, being treated and followed up routinely at the KEMRI- site and other selected health facilities in Western Kenya for SCD. The children will be randomized into two arms, with the Intervention Group receiving the recommended Ministry of Health (MoH)/World Health Organization (WHO) standard care in addition to three times weekly zinc supplementation (10 mg) and the Control Group receiving standard MoH care alone over a six month period. At baseline, at 3 months and at 6 months, clinical and laboratory evaluations, including serum zinc levels, malaria blood slides, anthropometric measurements and other indicated laboratory tests will be conducted. In addition, HIV testing will be carried out during the study as an important confounder. The differences in incidence of morbidity and other secondary endpoints will be compared between the zinc group and the control group.  The results are expected to determine the scientific basis for a larger clinical trial to determine the need for the addition of zinc supplement to the management of sickle cell disease.  </p>\n
      • study_title<p>\n <strong>The effects of Zinc supplementation in children with sickle cell disease in Western Kenya: a pilot study.</strong></p>\n
      • laymans_summary(null)
      • short_titleZINC in Sickle cell study
      • protocol_noECCT/15/06/02
      • version_no0.4
      • date_of_protocol24-01-2015
      • study_drugZinc Supplement
      • disease_conditionSickle Cell Disease
      • 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_nameZincfant
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressvictorine.owira@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_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)
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      • 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_applicantVictorine Owira
      • declaration_date108-06-2015
      • declaration_principal_investigatorDr Lucas Otieno Tina
      • declaration_date208-06-2015
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n Male or female infants and children ≥ 6 months and < 13 years of age with confirmed SCD. </p>\n
      • principal_exclusion_criteria<ul>\n <li style=\"margin-left: 1in;\">\n Profound clinical evidence of current immunosuppression or evidence of active AIDS defining illness i.e. WHO HIV clinical stage III/IV</li>\n <li style=\"margin-left: 1in;\">\n History of allergic reactions to zinc or any other ingredients in the supplement</li>\n <li style=\"margin-left: 1in;\">\n History of any neurologic disorders or seizures</li>\n <li style=\"margin-left: 1in;\">\n Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, renal functional abnormality, as determined by physical examination or laboratory screening tests</li>\n <li style=\"margin-left: 1in;\">\n Hemoglobin ≤5.0 g/dL </li>\n <li style=\"margin-left: 1in;\">\n Total White Cell Count below normal range <4.5 x 10³/uL</li>\n <li style=\"margin-left: 1in;\">\n Use of any investigational or non-registered drugs or vaccines or planned use</li>\n <li style=\"margin-left: 1in;\">\n Simultaneous participation in any other clinical trial (would it be worth increasing the age range to ensure vaccination schedule does not impact or get impacted?)</li>\n</ul>\n
      • primary_end_points<p style=\"margin-left:1.0in;\">\n Measurement of levels of zinc levels at 3 time points i.e. screening, study mid point and study conclusion.  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n The study has 3 investigators, 1 coordinator, 2 nurses and 2 clinical officers. The laboratories with capabilities of diagnosing Sickle cell disease in Western Kenya will be used.</p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration6 months
      • design_controlled_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
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaHealth Facilities in Western Kenya
      • single_site_physical_addressObama Children\'s Hospital, Located witning JOOTRH Kisumu-Kenya
      • single_site_contact_personDr Lucas Otieno
      • single_site_telephone+254720597654
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site40
      • total_participants_worldwide40
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentYes
      • population_above_18No
      • population_adultNo
      • 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_consentYes
      • subjects_specifyThe study will be enrolling children from 6 months to 13 years old.
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameLucas
      • investigator1_middle_nameOtieno
      • investigator1_family_nameTina
      • investigator1_qualificationMedical Doctor
      • investigator1_professional_address54, 40100 Kisumu-Kenya
      • investigator1_telephone+254720597654
      • investigator1_emailLucas.Tina@usamru-k.org
      • organisations_transferred_No
      • number_participants40
      • notification
      • approval_date17-08-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted15-06-2015
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2018-01-24 13:27:15
      • created2015-06-15 14:38:48
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id277
        • application_id405
        • given_nameLucas
        • middle_nameOtieno
        • family_nameTina
        • qualificationMedical Doctor
        • professional_address54, 40100 Kisumu-Kenya
        • telephone+254720597654
        • emailLucas.Tina@usamru-k.org
        • created2015-06-15 14:45:54
        • modified2015-06-15 15:42:06
    • SiteDetail(array)
      • 0(array)
        • id330
        • application_id405
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-06-15 14:45:54
        • modified2015-06-15 15:42:06
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id214
        • application_id405
        • sponsorGLAXOSMITHKLINE
        • sponsor_type(null)
        • contact_person
        • address54-40100 Kisumu
        • telephone_numberTel:+254-02-6933200
        • fax_number
        • cell_numberTel:+254-02-6933200
        • email_addressTina.lucas@usamru-k.org
        • created2015-06-15 14:45:54
        • modified2015-06-15 15:42:06
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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-> /var/www/html/ctr/lib/Cake/

Included Files

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