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• applications(array)
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    • Application(array)
      • id1108
      • user_id360
      • trial_status_id6
      • abstract_of_study<p>\n SARS-CoV-2, the cause of the coronavirus disease 2019 (COVID-19) pandemic, has evolved into new strains that are also referred to as ‘variants.’ A rapidly spreading variant called B.1.351, first identified in South Africa has now spread to Kenya. This variant is considered a ‘variant of concern’ because it is more transmissible than the original strain and because some vaccines appear to have reduced protection against this strain of SARS-CoV-2. In vitro, the B.1.351 variant’s mutations reduce efficiency of neutralizing antibodies induced by the Moderna mRNA (original Wuhan strain) vaccine. It is unknown whether this in vitro finding also reduces the clinical efficacy of the vaccine.</p>\n<p>\n The B.1.617 (Delta) variant is already the dominant strain in the UK and has spread rapidly to other countries in Eastern and Southern Africa including Kenya. The Moderna mRNA vaccine has shown that the serum of vaccinated participants one week after the 2nd dose is able to neutralize the Delta variant better than the Beta variant. Whether efficacy rates will be influenced by the apparent greater infectivity of the Delta variant remains to be determined.</p>\n<p>\n  New variants continue to arise (Alpha, Gamma, Epsilon, Zeta, Eta, Theta, Iota, Kappa and Lambda and it is clear that potent vaccines are needed, not only to protect the population from the medical complications of COVID-19, but also to determine if the vaccines being used are potent enough to prevent breakthrough acquisitions by multimutational variants.</p>\n<p>\n The relative risks that COVID-19 poses to People living with HIV (PLWH) compared to HIV-uninfected individuals is an area of active research. It is unclear that HIV status is a significant risk factor for poor outcomes from COVID-19 disease. Some of the largest studies examining HIV status and the risk of severe COVID-19 illness have reached inconsistent conclusions.</p>\n<p>\n The optimal COVID-19 mRNA vaccination regimen for PLWH is unknown. Moreover, there are no randomized controlled trials in any stage of vaccine development devoted to defining the efficacy endpoints of a COVID-19 vaccine among PLWH. PLWH are a major focus of this study given the current significant evidence gap regarding what vaccine regimens would best benefit this group. PLWH will constitute the largest proportion of the study population.</p>\n<p>\n We aim to test the safety and efficacy of Moderna’s mRNA vaccine in 14,000 participants recruited from eight African countries; 300 will be recruited in Kisumu. Participants will be over age 18 years with at least one comorbidity associated with severe COVID-19, or over 18 years of age and HIV-infected.</p>\n<p>\n The objective of this randomized, double-blind trial is to assess several regimens of the Moderna COVID-19 vaccine (mRNA-1273) vaccine in PLWH while differentiating between whether participants have a prior history of SARS-CoV-2 infection over 18 months. All participants will receive the vaccine. Participants will be grouped based on their HIV and SARS-CoV-2 serostatus at screening and then randomized 1:1 to either a 3-dose vs 2-dose vaccine regimen or 1-dose vs 2-dose vaccine regimen  CDC Africa encouraged testing various vaccines in the continent to be sure they are efficacious. The World Health Organization has recently listed the Moderna vaccine for emergency use listing. To date, mRNA vaccines have only recently been deployed in the African continent. If this trial is successful, it will provide a new weapon to control the pandemic in Africa and yield critical information on its efficacy against the new variants emerging in Kenya, including the B.1.351 and Delta variants of concern, as well as characterize an optimal COVID-19 mRNA vaccination regimen for PLWH.</p>\n
      • study_title<p>\n Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern</p>\n
      • laymans_summary<p>\n As at 26 Mar 2021, after the first COVID-19  case was confirmed in Kenya on 12 March 2020, a total of 126,170 confirmed cases have been  identified and 2,092  people have died giving a death rate of  1.7 persons per 100 people infected.</p>\n<p>\n The vaccine developed by Moderna and  based on the genetic information of the orignal viral strain that originated in Wuhan, China, was proven to be highly effective in preventing COVID-19 infections. It received an Emergency Use Authorization by the Food & Drug Administration and is now widely used in the USA but has not been used in the African continent. The Africa CDC has encouraged nations in its continent to test the effectiveness and safety of a variety of vaccines in their populations.</p>\n<p>\n As SARS-CoV-2 – the virus that causes COVID-19 – spreads around the globe, it is mutating. It changes in response to the different immune responses in different people. It changes to form new versions of the virus known as ‘variants’. Some examples include the ‘B1.1.7 or Alpha variant’ first discovered in the United Kingdom , the ‘B.1.351 or Beta variant’, first identified in South Africa and the ‘B.1.617 or Delta variant’ first identified in India. It is therefore important to assess whether the ability of the Moderna vaccine to prevent COVID-19 will be affected. The Moderna vaccine contains genetic material from the virus that causes COVID-19 that gives our bodies’ cells instructions for how to make a harmless protein that is unique to the virus. After our cells make copies of the protein, they destroy the genetic material from the vaccine. Our bodies recognize that the protein should not be there and increase immune cells that will remember how to fight the virus that causes COVID-19 if we are infected in the future. The immune cells produce substances known as antibodies which can stop a virus from infecting the body by affecting how the molecules on the virus’ surface can enter cells in the body.</p>\n<p>\n The SARS-CoV-2 South African variant has changes known to reduce how well the antibodies produced by some COVID-19 vaccines work. At this time, it is not clear whether the presence of such variants reduce how well the Moderna vaccine works to cause widespread vaccine failure. However as mentioned above, the vaccine also triggers formation of immune cells which may provide enough protection. It is also possible that the high amount of antibodies produced by the Moderna vaccine will provide enough protection despite reduced sensitivity of the South African virus.</p>\n<p>\n Since the South African and Indian variant are present and increasing in the Eastern and Southern African Region, it is important to perform a study evaluating the effectiveness of the Moderna vaccine. The study will assess the impact of the vaccine developed against the original virus on both moderate and severe disease and death in these regions among adults who are at high risk of severe disease. The study will also carefully examine breakthrough infections in fully vaccinated individuals. A breakthrough infection is a case of illness in which a vaccinated individual becomes sick from the same illness that the vaccine is meant to prevent. This is important so as to determine whether vaccines need to be tailor made for the different variants of concern  or if vaccines need to be modified to accommodate changes for universally effective vaccines, or whether the original vaccine will provide higher protection against severe disease when administered as a booster. (A booster dose is an extra administration of a vaccine after an earlier dose. It is intended to increase immunity after memory against a virus that may have declined over time.) This study will involve people who are at high risk for COVID-19.</p>\n<p>\n PLWH will be the largest group of people enrolled into the study. This is due to current insufficient scientific evidence about what vaccine schedule would best benefit PLWH.</p>\n<p>\n This trial is designed as a 2- versus 3- dose vaccine regimen in participants who have never been infected with SARS-CoV-2 (Groups 1 and 3) .It will compare 2 doses versus 1 dose of vaccine in participants who had a previous infection without symptoms and have a positive SARS-CoV-2 antibody test (Groups 2 and 4).</p>\n<p>\n The study aims to enroll approximately 14,000 participants, 12,600 people living with HIV and 1,400 HIV-negative participants. Among these, 5,000 participants will be confirmed to have a positive SARS-CoV-2 antibody test at screening.</p>\n<p>\n At screening, participants will be grouped based on their HIV status and whether they have a positive SARS-CoV-2 antibody test that indicates previous infection or not. They will then be grouped equally and randomly in a ratio of 1:1 to either a 3-dose vs 2-dose vaccine schedule or 1-dose vs 2-dose vaccine schedule.</p>\n<p>\n All participants will receive vaccine during this trial. At month 6 after enrollment, some participants will receive placebo, while some will receive vaccine. This depends on their randomization group.</p>\n
      • short_titleCoVPN 3008
      • protocol_noECCT/22/01/02
      • version_noVersion 4.0
      • date_of_protocol01-10-2021
      • study_drugCOVID-19 mRNA Vaccine
      • disease_conditionCOVID-19
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameplacebo: sodium chloride 0.9% for injection
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressirenekayilah1@gmail.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDr.Ben Andagalu
      • declaration_date114-01-2022
      • declaration_principal_investigatorTaraz Samandari
      • declaration_date214-01-2022
      • placebo_presentYes
      • study_objectives<p>\n 1.To assess the relative vaccine efficacy (RVE) of a 3- vs. 2-dose COVID-19 mRNA vaccine regimen to prevent virologically confirmed symptomatic COVID-19 in adult PLWH who are SARS-CoV-2 negative1 at baseline (Group 1), counting endpoints at least 14 days after Month 6 dose through end of follow-up</p>\n<p>\n 2.To assess the relative vaccine efficacy (RVE) of a 3- vs. 2-dose COVID-19 mRNA vaccine regimen to prevent severe COVID-19 in adult PLWH who are SARS-CoV-2 negative1 at baseline (Group 1), counting endpoints at least 14 days after Month 6 dose through end of follow-up. </p>\n<p>\n 3.To assess the safety and tolerability of COVID19 mRNA vaccine in adults who are at risk of severe COVID-19</p>\n
      • principal_inclusion_criteria<p>\n 1. Age ≥ 18 years if volunteer self-reports they are living with HIV and/or have at least one comorbidity known to be associated with severe COVID-19, for example (CDC.gov for exhaustive list):</p>\n<p>\n • Hypertension</p>\n<p>\n • Type 2 diabetes mellitus</p>\n<p>\n • Obesity (body mass index [BMI] of 30 kg/m2 or higher but < 40 kg/m2)</p>\n<p>\n • Severe Obesity (BMI ≥ 40 kg/m2)</p>\n<p>\n • Heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies</p>\n<p>\n • Chronic kidney disease</p>\n<p>\n • COPD (chronic obstructive pulmonary disease) CoVPN 3008 (Ubuntu) Version 4.0 / October 1, 2021 CoVPN3008_v4.0_FINAL_Oct1_2021 / Page 54 of 134</p>\n<p>\n • Cancer</p>\n<p>\n • Non-HIV immunocompromised state (weakened immune system) or solid organ transplant</p>\n<p>\n • Pregnancy</p>\n<p>\n • Sickle cell disease</p>\n<p>\n • Smoking</p>\n<p>\n 2. Willingness to be followed and remain in the catchment area for the planned duration of the study.</p>\n<p>\n 3. Ability and willingness to provide informed consent.</p>\n<p>\n 4. Willingness to discuss HIV infection status, undergo related testing/monitoring labs, and receive counseling and referrals to minimize HIV acquisition/improve HIV care, as appropriate based on their infection status.</p>\n<p>\n 5. Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with demonstration of understanding of all questionnaire items answered incorrectly.</p>\n<p>\n 6. Agrees not to enroll in another study of an investigational research agent until the end of the study. Enrollment in studies of investigational research agents for the treatment of COVID-19 is allowed for participants who develop COVID-19 disease. </p>\n
      • principal_exclusion_criteria<p>\n 1. Acutely ill 72 hours prior to or at screening. Volunteers meeting this criterion may be rescheduled within the relevant window periods. Participants with minor illnesses can be enrolled at the discretion of the investigator.</p>\n<p>\n 2. History of angioedema or anaphylaxis.</p>\n<p>\n 3. Self-reported previous COVID-19 diagnosis. Vaccines and other Injections</p>\n<p>\n 4. Prior receipt of a SARS-CoV-2 vaccine. CoVPN 3008 (Ubuntu) Version 4.0 / October 1, 2021 CoVPN3008_v4.0_FINAL_Oct1_2021 / Page 55 of 134</p>\n<p>\n 5. History of severe allergic reaction to any ingredient of this vaccine (lipids (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate trihydrate, and sucrose).</p>\n<p>\n 6. Live attenuated vaccines received within 30 days before first vaccination (eg, measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever; live attenuated influenza vaccine, live attenuated zoster vaccine).</p>\n<p>\n 7. Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, human papilloma virus (HPV), pneumococcal, Hepatitis A or B).</p>\n<p>\n 8. Blood products, systemic immunoglobulins, or monoclonal antibodies (including against SARS-CoV-2) received within 90 days before first vaccination. </p>\n
      • primary_end_points<p>\n 1. COVID-19: Positive result of acute SARSCoV-2 infection as assessed by nucleic acid amplification testing (NAAT) of a nasal swab whose collection was triggered by a prespecified symptom or symptoms (see footnote 2)</p>\n<p>\n 2.Severe COVID-19: COVID-19 that meets the criteria listed in footnote 3 AND adjudicated by an independent endpoint adjudication committee</p>\n<p>\n 3.Adverse events: Solicited and unsolicited AEs collected for a subset of study participants. Serious adverse events (SAEs), adverse events of special interest (AESIs), collected for all participants throughout the study </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • 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_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p font-size:=\"\" font-variant-east-asian:=\"\" font-variant-numeric:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Site Facilities: 35 Facilities out of which 6 can hospitalize. Kombewa County Hospital is the referral point for all the facilities in Seme sub County, while Chulaimbo is the referral facility in Kisumu West County. The patients are referred to Jaramogi Oginga Odinga Teaching and referral hospital, Avenue Hospital, in case of an emergency.</p>\n<p font-size:=\"\" font-variant-east-asian:=\"\" font-variant-numeric:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n The unit  has the following staff for the study,  4 paedricians, 4 medical offices, 4 clinical offices, 2 study coordinators,7 Lab technologist, 9 nurses, 1 phamacist, 2 phamacy technologist, 8 data clearks and 38 filedworkers.The unit has two storey building consisiting of office space, lab, clinical rooms, archives.</p>\n
      • other_details_explanation<p>\n COVID-19 is a psndemic hence COVID-19 trials are being conducted across multiple sites in Africa.</p>\n
      • other_details_regulatory_notapproved<p>\n KEMRI- SERU(Scientific and Ethics Review Unit.</p>\n
      • other_details_regulatory_approved<p>\n Kenya Pharmacy and Poisons Board</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration1 year
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherYes
      • design_controlled_specifyImmediate vs deferred vaccination with blinded crossover
      • design_controlled_comparatorSodium chloride 0.9%
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states7
      • number_of_sites2
      • multi_country_listBotswana, Uganda, Kenya, Malawi,Eswatini,South Africa,Zimbabwe
      • data_monitoring_committeeYes
      • total_enrolment_per_site300
      • total_participants_worldwide14,000
      • 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_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersYes
      • subjects_others_specifyAge 40 and at least one comorbidity known to be associated with severe COVID-19\nAge ≥ 18 and pregnant\nAge ≥ 18 and HIV infected
      • investigator1_given_nameTaraz
      • investigator1_middle_name
      • investigator1_family_nameSamandari
      • investigator1_qualificationMD, PhD
      • investigator1_professional_addressKEMRI Centre for Global Health Research (CGHR), P.O. Box 1578, Kisumu, Kenya
      • investigator1_telephone+254-57-2022929/02/59/83
      • investigator1_emailtts0@cdc.gov
      • organisations_transferred_No
      • number_participants500
      • notification
      • approval_date14-04-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted15-02-2022
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe queries raised have been addressed
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-04-24 14:15:14
      • created2022-01-05 09:51:10
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id783
        • application_id1108
        • given_nameBen
        • middle_nameMadeke
        • family_nameAndagalu
        • qualificationMD
        • professional_addressKEMRI-USAMRD-A,P.O.BOX 54-40100 Kisumu
        • telephone+254716004851
        • emailben.andagalu@usamru-k.org
        • created2022-01-05 10:31:54
        • modified2022-02-15 14:30:41
    • SiteDetail(array)
      • 0(array)
        • id1226
        • application_id1108
        • county_id42
        • site_nameKEMRI -USAMRD-A, Kombewa Clinical Research Centre
        • physical_addressOff Kisumu Bondo Road, Opposite Kombewa County Hospital
        • contact_detailsP.O.Box 54-40100 Kisumu
        • contact_personDr.Ben Andagalu
        • site_capacity(null)
        • misc(null)
        • created2022-01-05 10:31:54
        • modified2022-02-15 14:30:41
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id1227
        • application_id1108
        • county_id42
        • site_nameKEMRI-CGHR
        • physical_addressJaramogi Oginga Odinga Teaching and Referal Hospital
        • contact_detailsP.O.Box 1578 Kisumu
        • contact_personDr.Grace Mboya
        • site_capacity(null)
        • misc(null)
        • created2022-01-05 11:06:59
        • modified2022-02-15 14:30:41
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id572
        • application_id1108
        • sponsorSouth African Medical Research Council
        • sponsor_typeOthers
        • contact_person
        • addressFrancie Van Zijl Drive parowvallei, cape town P.O.Box 19070 7505 Tygerberg, South Africa
        • telephone_number+27219380911
        • fax_number
        • cell_number+27219380911
        • email_addressinfo@mrc.ac.za
        • created2022-01-05 10:31:54
        • modified2022-02-15 14:30:41
  • 1(array)
    • Application(array)
      • id1007
      • user_id480
      • trial_status_id6
      • abstract_of_study<p>\n SARS-CoV-2, the cause of the coronavirus disease 2019 (COVID-19) pandemic, has evolved into new strains that are also referred to as ‘variants.’ A rapidly spreading variant called B.1.351, first identified in South Africa has now spread to Kenya. This variant is considered a ‘variant of concern’ because it is more transmissible than the original strain and because some vaccines appear to have reduced protection against this strain of SARS-CoV-2. In vitro, the B.1.351 variant’s mutations reduce efficiency of neutralizing antibodies induced by the Moderna mRNA (original Wuhan strain) vaccine. It is unknown whether this in vitro finding also reduces the clinical efficacy of the vaccine. We aim to test the safety and efficacy of Moderna’s two-dose mRNA vaccine in 14,000 participants recruited from eight African countries; 300 will be recruited in Kisumu. Participants will be over age 40 years with at least one comorbidity associated with severe COVID-19, or over 18 years of age and pregnant, or over 18 years of age and HIV-infected. The objectives of this randomized, double-blind, immediate versus deferred vaccination trial with cross-over at approximately three months are to assess vaccine efficacy to prevent virologically confirmed or virologically unconfirmed symptomatic COVID-19. All participants will receive the vaccine. The ratio of participants in immediate and deferred arms is 1:1. CDC Africa encouraged testing various vaccines in the continent to be sure they are efficacious. The World Health Organization has recently listed the Moderna vaccine for emergency use listing. To date, mRNA vaccines have hardly been deployed in the African continent. If this trial is successful, it will provide a new weapon to control the pandemic in Africa and yield critical information on its efficacy against the new variants emerging in Kenya, including the B.1.351 variant of concern.</p>\n
      • study_title<p>\n Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern</p>\n
      • laymans_summary<p>\n Since 12 March 2020 when the first COVID-19 case was confirmed in Kenya, as at 26 Mar 2021, a total of 126,170 confirmed cases have been identified and 2,092 people have died yielding a death rate of 1.7 persons per 100 people infected. The mRNA vaccine developed by Moderna and based on the genetic information of the orignal viral strain that originated in Wuhan, China, was proven to be highly efficacious in preventing COVID-19 infections. It received an Emergency Use Authorization by the Food & Drug Administration and is now widely used in the USA but has not been used in the African continent. The Africa CDC has encouraged nations in its continent to test the efficacy and safety of a variety of vaccines in their populations. As SARS-CoV-2 – the virus that causes COVID-19 – spreads around the globe, it is mutating. It changes in response to the different immune responses in different people. It changes to form new variants for example the B1.1.7 variant first discovered in the United Kingdom and the B.1.351, first identified in South Africa. It is therefore important to assess whether the ability of the Moderna mRNA vaccine to prevent Covid 19 will be affected. The Moderna mRNA vaccine contains material from the virus that causes COVID-19 that gives our cells instructions for how to make a harmless protein that is unique to the virus. After our cells make copies of the protein, they destroy the genetic material from the vaccine. Our bodies recognize that the protein should not be there and build T-lymphocytes (a type of white blood cell) and B-lymphocytes that will remember how to fight the virus that causes COVID-19 if we are infected in the future. The B lymphocytes produce substances known as neutralizing antibodies which can stop a virus from infecting the body by affecting how the molecules on the virus’ surface can enter cells in the body. The SARS-CoV-2 South African variant has changes known to reduce how well the neutralizing antibodies produced by the Moderna mRNA vaccine work. At this time, it is not clear whether this can reduce how well the vaccine works and cause widespread vaccine failure. However as mentioned above, the vaccine also triggers formation of T lymphocytes which may provide enough protection. It is also possible that the high amount of neutralizing antibodies produced by the Moderna mRNA vaccine will provide enough protection despite reduced sensitivity of the South African virus. Since the South African variant is present and increasing in the Eastern and Southern African Region, it is important to perform a vaccine efficacy study. The study will assess the clinical impact of the parent mRNA vaccine (i.e., original Wuhan strain) on both moderate and severe disease and death in these regions among adults who are at high risk of severe disease. The study will also carefully examine breakthrough viruses in fully vaccinated individuals. A breakthrough infection is a case of illness in which a vaccinated individual becomes sick from the same illness that the vaccine is meant to prevent. This is important so as to determine whether vaccines need to be tailor made for the different variants of concern or if vaccines need to be modified to accommodate changes for global vaccines, and whether the original vaccine will provide higher protection against severe disease when administered as a booster. (A booster dose is an extra administration of a vaccine after an earlier dose. It is intended to increase immunity after memory against a foreign substance eg. a virus has declined through time). This study will involve people who are at high risk for COVID-19. This trial has an immediate vs. delayed design, eventually immunizing all participants with the vaccine but delaying by three months (at the crossover visit) the immunization of half of participants to assess the efficacy of the mRNA vaccine. Fourteen thousand participants will be recruited from eight African countries, with approximately three hundred from the Kisumu Clinical Research Site. Although a great deal is known about the safety of the Moderna vaccine in the US, this trial will provide an opportunity to test the vaccine’s safety in African populations.</p>\n
      • short_titleCoVPN 3008
      • protocol_noECCT/21/05/07
      • version_no1.0
      • date_of_protocol16-05-2021
      • study_drugCOVID-19 mRNA Vaccine
      • disease_conditionCovid 19
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_name
      • product_type_medical_device_nameVaccine
      • comparatorYes
      • comparator_namePlacebo: Sodium Chloride 0.9 % for injection
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresseodipo@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_countries(null)
      • 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_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDr. Grace Mboya
      • declaration_date127-05-2021
      • declaration_principal_investigatorPhilister Madiega
      • declaration_date227-05-2021
      • placebo_presentYes
      • study_objectives<ol start=\"1\">\n <li>\n To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent virologically-confirmed symptomatic COVID-19 starting 14 days after dose 2 in adults who are at risk of severe COVID-19</li>\n <li>\n To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent severe COVID-19 starting 14 days after dose 2 in adults who are at risk for severe COVID-19</li>\n <li>\n To assess safety and tolerability of COVID-19 mRNA vaccine in adults who are at risk of severe COVID-19</li>\n</ol>\n
      • principal_inclusion_criteria<p>\n 1.Age ≥ 18 years if volunteer self-reports pregnant OR HIV-positive, OR age ≥ 40 years with ≥ 1 co-morbidity known to be associated with severe COVID-19, for example:</p>\n<p>\n • Hypertension</p>\n<p>\n • Type 2 diabetes mellitus</p>\n<p>\n • Obesity (body mass index [BMI] of 30 kg/m2 or higher but < 40 kg/m2)</p>\n<p>\n • Severe Obesity (BMI ≥ 40 kg/m2</p>\n<p>\n • Heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies</p>\n<p>\n • Chronic kidney disease • COPD (chronic obstructive pulmonary disease)</p>\n<p>\n • Cancer .</p>\n<p>\n 2.Non-HIV immunocompromised state (weakened immune system) or solid organ transplant • Pregnancy Willingness to be followed and remain in the catchment area for the planned duration of the study.</p>\n<p>\n 3. Ability and willingness to provide informed consent.</p>\n<p>\n 4. Willingness to discuss HIV infection risks and willing to receive HIV testing, risk reduction counseling, and appropriate referrals to minimize HIV acquisition, if volunteer is pregnant</p>\n<p>\n 5. Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with demonstration of understanding of all questionnaire items answered incorrectly.</p>\n<p>\n 6. Willing to defer SARS-CoV-2 vaccination until the crossover visit (anticipated at approximately Month 3.5).</p>\n<p>\n 7. Agrees not to enroll in another study of an investigational research agent until the end of the study. Enrollment in studies of investigational research agents for the treatment of COVID-19 is allowed for participants who develop COVID-19 disease. • Sickle cell disease • Smoking</p>\n
      • principal_exclusion_criteria<p>\n 1. Acutely ill 72 hours prior to or at screening. Volunteers meeting this criterion may be rescheduled within the relevant window periods. Participants with minor illnesses can be enrolled at the discretion of the investigator.</p>\n<p>\n 2. History of angioedema or anaphylaxis</p>\n<p>\n 3. Self-reported previous COVID-19 diagnosis</p>\n<p>\n 4. Prior administration of a SARS-CoV-2 vaccine.</p>\n<p>\n 5. Live attenuated vaccines received within 30 days before first vaccination or scheduled within 14/28 days after injection (eg, measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever; live attenuated influenza vaccine).</p>\n<p>\n 6. Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, pneumococcal, Hepatitis A or B). 7. Blood products, systemic immunoglobulins, or monoclonal antibodies (including against SARS-CoV-2) received within 90 days before first vaccination</p>\n
      • primary_end_points<ol>\n <li>\n COVID-19: Positive result of acute SARS-CoV-2 infection as assessed by nucleic acid amplification testing (NAAT) or antigen testing of a nasal swab whose collection was triggered by a prespecified symptom or symptoms (see footnote 1) in volunteers with no previous COVID-19</li>\n <li>\n Severe COVID-19: COVID-19 that meets the criteria listed in footnote 2 AND adjudicated by an independent endpoint adjudication committee, in baseline SARS-CoV-2 negative participants.</li>\n <li>\n Solicited and unsolicited AEs collected for a subset of study participants after the initial set of vaccinations. Serious adverse events (SAEs), adverse events of special interest (AESIs), collected for all participants throughout the study.</li>\n</ol>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • 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_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n The site has different sections that will ensure the study is performed as per the protocol and also Good Clinical practice.. Apart from the Principal investigators and co investigaors the different Sections will include 1 receptionist, 1 data manager, 1 data Clerk, 4 nurses, 2 clinical officers, 21Medical officer, 2Harmacist(1 Pharmacist of record and 1 Associate), 2 Quality Managenet officers , 1 records officer and 2 laboratory technicians</p>\n<p>\n The Kisumu CRS has a state of the art laboratory, clinic and pharmacy .</p>\n<p>\n Other supporting sections include the ICT section, transport department as well as the administration department</p>\n
      • other_details_explanation<p>\n This is because the trial is a Covid 19 trial and because this is a pandemic the trial is being conducted in multiple sites in Africa</p>\n
      • other_details_regulatory_notapproved<p>\n KEMRI Scientifics and Ethics Review Unit-27 May 2021</p>\n
      • other_details_regulatory_approved<p>\n None at this point</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration1 year
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherYes
      • design_controlled_specifyimmediate vs. deferred vaccination with blinded crossover
      • design_controlled_comparatorSodium Chloride 0.9%
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states7
      • number_of_sites2
      • multi_country_listBotswana, Uganda, Kenya, Malawi, Eswatini, South Africa, Zimbabwe
      • data_monitoring_committeeYes
      • total_enrolment_per_site300
      • total_participants_worldwide14,000
      • 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_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersYes
      • subjects_others_specifyage ≥ 40 and at least one comorbidity known to be associated with severe COVID-19, 2) age ≥ 18 and pregnant, 3) age ≥ 18 and HIV-infected.
      • investigator1_given_namePhilister
      • investigator1_middle_name Adhiambo
      • investigator1_family_nameMadiega
      • investigator1_qualificationResearcher
      • investigator1_professional_addressPO BOX 1578 Kisumu
      • investigator1_telephone0703704299
      • investigator1_emailPadhiambo@kemricdc.org
      • organisations_transferred_No
      • number_participants500
      • notification
      • approval_date05-08-2021
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted05-08-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe application has been approved by the experts
      • final_report
      • implication_results
      • quantity_imported
      • quantity_dispensed
      • quantity_destroyed
      • quantity_exported
      • balance_site
      • final_date0000-00-00
      • modified2025-01-15 08:16:32
      • created2021-05-22 16:22:47
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id655
        • application_id1007
        • given_nameGrace
        • middle_nameMboya
        • family_nameMugure
        • qualificationMedical Officer
        • professional_addressPO BOX 1578 Kisumu
        • telephone0705300452
        • emailGmboya@kemricdc.org
        • created2021-05-24 14:41:49
        • modified2021-08-05 06:28:22
    • SiteDetail(array)
      • 0(array)
        • id904
        • application_id1007
        • county_id42
        • site_nameKEMRI CGHR Kisumu Clinical Research Site
        • physical_addressJaramogi Oginga Odinga Teaching and Referal Hospital
        • contact_detailsPO BOX 1578 Kisumu
        • contact_personDr. Grace Mboya
        • site_capacity(null)
        • misc(null)
        • created2021-05-24 14:41:49
        • modified2021-08-05 06:28:22
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id500
        • application_id1007
        • sponsorSouth African Medical Research Council
        • sponsor_typeOthers
        • contact_person
        • addressFrancie van Zijl Drive Parowvallei, Cape Town; PO Box 19070 7505 Tygerberg, South Africa
        • telephone_number+27 21 938 0911
        • fax_number
        • cell_number+27 21 938 0911
        • email_addressinfo@mrc.ac.za
        • created2021-05-24 14:41:49
        • modified2021-08-05 06:28:22
  • 2(array)
    • Application(array)
      • id511
      • user_id335
      • trial_status_id5
      • abstract_of_study<p>\n <strong>Introduction</strong></p>\n<p>\n Sickle cell disease is an inherited blood disorder resulting from a genetic mutation of the beta</p>\n<p>\n hemoglobin chain (HbSS), with high prevalence in Sub-Saharan Africa. Due to a complex interplay of adhesive events, these altered erythrocytes can obstruct the vasculature, producing episodes of pain, organ ischemia and infarction and early mortality.  Activated platelets promote the adherence of sickle cells to endothelial cells and thus participate in the vaso-occlusive process.  Inhibition of platelet activation has therefore been proposed as a potential therapeutic option in the treatment of children and adults with SCD.</p>\n<p>\n Ticagrelor is an orally active, reversibly binding cyclopentyl-triazolo-pyrimidine P2Y₁₂ receptor antagonist that produces dose‑related inhibition of adenosine diphosphate (ADP) induced platelet aggregation. Ticagrelor is indicated to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS). The ticagrelor development program to date has focused on adult patients since there is no paediatric correlate for the adult condition of ACS. This study will therefore seek to characterise the relationship between ticagrelor dose and inhibition of platelet aggregation in paediatric patients with SCD to support a Phase III study.</p>\n<p>\n <strong>Primary Objective:</strong></p>\n<p>\n To characterise the relationship between ticagrelor dose and inhibition of platelet aggregation in paediatric patients with SCD, using PK-PD modelling, to support dose selection for Phase III</p>\n<p>\n <strong>Secondary Objective:</strong></p>\n<p style=\"margin-left:32.2pt;\">\n 1.       To determine the PK properties of ticagrelor and its active metabolite in paediatric patients with SCD and to assess impact of weight, age and other demographic on the ticagrelor pharmacokinetics.</p>\n<p style=\"margin-left:32.2pt;\">\n 2.       Investigation of efficacy of ticagrelor vs. placebo in paediatric patients with SCD in reducing the number and severity of VOCs</p>\n<p style=\"margin-left:32.2pt;\">\n 3.       To assess safety and tolerability of single and multiple doses of ticagrelor in paediatric patients with SCD</p>\n<p style=\"margin-left:32.2pt;\">\n 4.       To determine the percent of patients with haemorrhagic events requiring medical intervention.</p>\n<p style=\"margin-left:32.2pt;\">\n 5.       Investigation of efficacy of ticagrelor vs. placebo in paediatric patients with SCD in reducing frequency and intensity of pain*</p>\n<p>\n * These do not apply to the study arm in Kenya</p>\n<p>\n <strong>Study site(s) and number of subjects planned</strong></p>\n<p>\n This study is currently conducted in 5 countries (United States, United Kingdom, South Africa, Canada and Lebanon) and approximately 8 to 20 sites, with a minimum of 36 patients and a maximum of 50 patients to be randomised in the study, depending on how many patients are required in order to have 36 evaluable patients.</p>\n<p>\n <strong>Study design</strong></p>\n<p>\n This is a multicenter, open-label, dose-ranging study of ticagrelor followed by a double blind, placebo-controlled extension phase in paediatric patients with sickle cell disease (SCD). </p>\n<p>\n <strong>Part A:</strong> Patients will be randomised in a 1:1 ratio to receive one of the two dosing schedules. All patients will receive 0.75 mg/kg as their initial single dose, followed 7 days later by 1.125 mg/kg or 2.25 mg/kg with determination of pharmacokinetic (PK) parameters and pharmacodynamic (PD) platelet inhibition following each single dose. The PK and platelet aggregation data are intended to support modelling-based selection of a weight-based dose for Phase III. Platelet aggregation will be measured using the VerifyNow™ P2Y₁₂ assay and reported as P2Y₁₂ reaction units (PRU).</p>\n<p>\n Following the 2 single doses, all patients will receive open-label one-week treatment with ticagrelor 0.75 mg/kg twice daily to determine tolerability prior to randomisation into Part B.</p>\n<p>\n <strong>Part B</strong>: Part B will be optional for patients. The investigator should present Part B to each patient and the decision to participate in Part B should be made by the patient (or parents/legal guardian). In this part patients will be randomised (2:1 ratio) to ticagrelor 0.75 mg/kg twice daily or placebo for a 4-week treatment phase. In some countries (Lebanon, Ghana, and Kenya), Part B will not be performed.</p>\n<p>\n <strong>Kenya centres: In Kenya patients will not be randomised to Part B. The patients will finish study treatment after 1 week open-label treatment and will visit site 30 days after treatment is stopped for follow-up. </strong></p>\n<p>\n During the study, patients will be followed for the occurrence of vaso-occlusive crisis (VOC) and for other disease manifestations such as daily pain, analgesic use and complications of SCD.</p>\n<p>\n For safety reasons the dosing schedule will be modified for individual patients as follows: If PRU at 2 hr following dosing of 0.75 mg/kg is <95, the subsequent maximum dose for this patient will be 0.563 mg/kg throughout the study. If PRU <95 following dosing of 0.563 mg/kg, the patient will be discontinued from further study drug.</p>\n<p>\n Since Part A of the study is open‑label, the PK and PD results will be monitored as the study proceeds and the doses may be further adjusted in both Part A and B based on emerging PK and PD results. Doses may be adjusted following assessment by AstraZeneca and the Steering Committee of open-label Part A results in the first 6 to 12 patients randomised under this amendment. Dose adjustment decisions will be based upon a review of PK, PD and adverse events.</p>\n<p>\n <strong> Target subject population</strong></p>\n<p>\n Patients eligible for this study include all children aged ≥2 to <18 years of age (age from birth to Visit 1) who are diagnosed with SCD (homozygous sickle cell [HbSS] or sickle beta‑zero‑thalassemia [HbS/β⁰]). </p>\n<p>\n <strong>Duration of treatment</strong></p>\n<p>\n In Part A the treatment period consists of 2 single doses (separated by at least 7 days) followed by 7 days open-label ticagrelor treatment twice daily. In Part B patients will be randomised to 4 weeks twice-daily treatment. There is no washout period between Part A and Part B. The total expected study duration for an individual patient participating in both Part A and Part B is approximately 3 months (including 30 days follow-up after last dose) and approximately 2 months for an individual patients participating in only Part A (including 30 days follow-up after last dose). For Kenya centres, Part B will not be conducted).</p>\n<p>\n <strong>Investigational product, dosage and mode of administration</strong></p>\n<p>\n <strong>Part A:</strong></p>\n<p>\n Ticagrelor 0.563 mg/kg, 0.75 mg/kg, 1.125 mg/kg or 2.25 mg/kg given as oral single doses.</p>\n<p>\n Ticagrelor 0.563 mg/kg or 0.75 mg/kg twice daily given orally.</p>\n<p>\n These doses may be adjusted based upon evaluation of PK/PD data as described in Appendix E of full protocol attached.</p>\n<p>\n <strong>Part B:</strong></p>\n<p>\n Ticagrelor 0.563 mg/kg or 0.75 mg/kg twice daily given orally and matching placebo.</p>\n<p>\n These doses may be adjusted based upon evaluation of PK/PD data as described in Appendix E.</p>\n<div>\n <p>\n The investigational product (active or placebo) will be granules for oral suspension supplied in glass bottles. Before each dosing occasion the granules will be constituted with 10 mL of purified water in the glass bottle to form a suspension suitable for oral dosing.</p>\n <p>\n <strong>Statistical methods</strong></p>\n <p>\n The relationship between ticagrelor dose, plasma concentration and PRU will be characterized using a population PK/PD approach (i.e non-linear mixed effect modelling). This analysis will be based on all available PK and PRU data from which complete dosing and sampling history is collected.</p>\n <p>\n No statistical comparisons are planned for the primary objective. PK, PD and safety measures will be summarised descriptively.</p>\n <p>\n A statistical analysis will be done comparing ticagrelor and placebo for each of the following variables:</p>\n <p>\n ·                              Percentage of days with pain (ages ≥4 years only)</p>\n <p>\n ·                              Percentage of days of opioid analgesic use</p>\n <p>\n ·                              Percentage of days of analgesic use (ages ≥4 years only)</p>\n <p>\n ·                              Percentage of days hospitalized for VOC or other complications of SCD</p>\n <p>\n ·                              Percentage days of absence from school or work (ages ≥6 years only)</p>\n <p>\n A t-test will be performed for each of these variables at 5% significance level, provided that the efficacy analysis set contains at least 30 patients, otherwise only descriptive statistics will be used. The p-value and a 95% confidence interval for the difference between ticagrelor and placebo will be reported. There will be no adjustment for multiple comparisons. If it is inappropriate to assume a normal distribution, a Wilcoxon rank sum test may be performed. Number of VOC requiring hospitalization and intensity of pain will be summarised descriptively.</p>\n <p>\n For Kenya centres, no comparison of ticagrelor vs placebo will be done; all efficacy variables and exploratory variables will be summarised descriptively.</p>\n</div>\n<p>\n  </p>\n
      • study_title<p>\n Multicentre, open-label, randomised, pharmacokinetic (PK) and pharmacodynamic (PD) dose-ranging Phase II study of ticagrelor followed by a double-blind, randomised, parallel-group, placebo-controlled 4 weeks extension phase in paediatric patients with sickle cell disease</p>\n
      • laymans_summary(null)
      • short_titleHESTIA 1
      • protocol_noECCT/16/07/05
      • version_no1
      • date_of_protocol03-02-2016
      • study_drugTiicagrelor
      • 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_nameTicagrelor
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjgithanga3@gmail.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries1
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
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      • applicant_practice_license(null)
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      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantProf Jessie N Githanga
      • declaration_date120-07-2016
      • declaration_principal_investigatorProf Jessie N. Githanga - Coordinating investigator
      • declaration_date220-07-2016
      • placebo_presentYes
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n 1.   Children aged ≥2 to <18 years* of age and body weight >16 kg to <70 kg diagnosed with homozygous sickle cell (HbSS) or sickle beta-zero-thalassaemia (HbS/β⁰).</p>\n<p>\n 2.   If ≤16 years, must have had transcranial Doppler (TCD) within the past year prior to Visit 1. If this is not the case, a TCD examination must be done before proceeding in the study.</p>\n<p>\n 3.    If ≥6 years old, must have had an ophthalmological examination within the past year prior to Visit 1. If this is not the case, the patient must be examined by an ophthalmologist before proceeding in the study.</p>\n<p>\n 4.   If treated with an anti-sickling agent such as hydroxyurea, the weight-adjusted dose must be stable for 1 month before enrolment.</p>\n<p>\n 5. Suitable venous access for the study-related blood sampling.</p>\n<p>\n 6.  Provision of signed and dated written informed consent prior to any study specific procedures that are not part of standard medical care, (local regulations and international guidelines are to be followed in determining the assent/consent requirements for children).</p>\n<p style=\"margin-left:14.2pt;\">\n *    Age from birth to Visit 1. </p>\n
      • principal_exclusion_criteria<p style=\"margin-left:36.0pt;\">\n 1.      Previous history of transient ischemic attack (TIA) or clinically overt cerebrovascular accident (CVA) (ischemic or haemorrhagic), severe head trauma, intracranial haemorrhage, intracranial neoplasm, arteriovenous malformation, aneurysm, or proliferative retinopathy.</p>\n<p style=\"margin-left:36.0pt;\">\n 2.      Findings on TCD: Current or previous values for time averaged mean of the maximum velocity (TAMMV) that are Conditional or Abnormal*.</p>\n<p style=\"margin-left:72.0pt;\">\n Conditional TAMMV values are ≥153 cm/sec using imaging TCD (TCDi) technique (corresponding to ≥170 cm/sec by the non-imaging technique). Both the middle cerebral artery and the internal carotid artery should be considered. Abnormal TAMMV values are ≥180 cm/sec using TCDi (corresponding to ≥200 cm/sec by the non-imaging technique) and are an indication for chronic transfusions because of a high stroke risk. Any other criteria that would locally be considered as TCD indications for chronic transfusion would also exclude the patient.</p>\n<p style=\"margin-left:36.0pt;\">\n 3.      Undergoing treatment with chronic RBC transfusion therapy.</p>\n<p style=\"margin-left:36.0pt;\">\n 4.      Use of non-steroidal anti-inflammatory drugs (NSAIDs) >3 days per week.</p>\n<p style=\"margin-left:36.0pt;\">\n 5.      Receiving chronic treatment with anticoagulants or antiplatelet drugs that cannot be discontinued.</p>\n<p style=\"margin-left:36.0pt;\">\n 6.      Moderate or severe hepatic impairment, defined as Child-Pugh Class B or C (see Appendix H) or renal failure requiring dialysis.</p>\n<p style=\"margin-left:36.0pt;\">\n 7.      Active pathological bleeding or increased risk of bleeding complications according to Investigator.</p>\n<p style=\"margin-left:36.0pt;\">\n 8.      Patient considered to be at risk of bradycardic events (eg, known sick sinus syndrome or second or third degree atrioventricular block) unless already treated with a permanent pacemaker.</p>\n<p style=\"margin-left:36.0pt;\">\n 9.      Concomitant oral or intravenous therapy (see Restrictions) with strong CYP3A4 inhibitors**, CYP3A4 substrates with narrow therapeutic indices, or strong CYP3A4 inducers**, which cannot be stopped at least five half-lives, but not shorter than 10 days, before enrolment.</p>\n<p style=\"margin-left:36.0pt;\">\n 10.  Surgical procedure planned to occur during the study.</p>\n<p style=\"margin-left:36.0pt;\">\n 11.  Patients who are currently pregnant or breastfeeding, or planning to become pregnant during the study.</p>\n<p style=\"margin-left:36.0pt;\">\n 12.  Females (if after menarche) who are not willing to use a highly effective method of contraception which results in a low failure rate (i.e. less than 1% per year).</p>\n<p style=\"margin-left:36.0pt;\">\n 13.  Known hypersensitivity or contraindication to ticagrelor.</p>\n<p style=\"margin-left:36.0pt;\">\n 14.  Concern for the inability of the patient or parents to comply with study procedures and/or follow-up.</p>\n<p style=\"margin-left:36.0pt;\">\n 15.  Any condition which, in the opinion of the Investigator, would make it unsafe or unsuitable for the patient to participate in this study.</p>\n<p style=\"margin-left:36.0pt;\">\n 16.  Previous randomisation in the present study***.</p>\n<p style=\"margin-left:36.0pt;\">\n 17.  Participation in another clinical study with an investigational product or device during the last 30 days preceding enrolment.</p>\n<p style=\"margin-left:36.0pt;\">\n 18.  Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).</p>\n<p>\n  </p>\n
      • primary_end_points<p>\n The primary study endpoint is the evaluation of the pharmacokinetic and pharmacodynamic properties of ticagrelor and its active metabolite in children after administration as single doses and after attainment of steady-state following twice-daily administration of ticagrelor.</p>\n<p>\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response1
      • 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_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Site No 8501 Gertudes Children's Hospital Sub-investigators: Dr. Jaspreet Singh, consultant paediatrician; Dr Nyambura Kariuki – consultant paediatric haemato-oncologist. Pharmacist: Dr Monica Mirigo Gichuhi   Nurse/coordinator – Grace Njuguna</p>\n<p>\n Gertrude’s Children’s Hospital (GCH) is a dedicated children’s specialist hospital founded as a non-profit organization.  Based in Muthaiga, Nairobi, and spread out to various outpatient clinics including in Mombasa, the hospital attends to over 300,000 children as outpatients and admits over 6,000 patients on average per year.  The 100-bed hospital offers comprehensive paediatric medical services and there are 21 specialist clinics that cover almost every aspect of paediatric healthcare including haematology, chest conditions, cardiology, dermatology, otorhinolaryngology, endocrinology, oncology and HIV/AIDS. The Hospital has a laboratory equipped with modern equipment offering diagnostic laboratory testing in all areas of pathology and is headed by a pathologist supported by a laboratory manager, qualified medical laboratory technologists and a group of sub-specialist pathologists.  The pharmacy is manned by qualified pharmacists and a specified pharmacist will be managing the study subject medications.  GCH has an up-to-date paediatric imaging facility that is managed by a qualified radiologist and radiographers.  Most of the processes at the hospital are computerized and supported by a well-integrated Information Technology Department.  The Hospital is Muthaiga is open 24hours every day of the week and offers 24 hour laboratory and pharmacy coverage. Emergencies are attended to in the outpatient facility.  The population served by the hospital is cosmopolitan and English and Kiswahili are the predominantly spoken languages.     The site  completed a similar study on prasugral (antiplatelet agent) in children < 18 years.</p>\n<p>\n  Site 8502 – PI Videlis Nduba -  Dr. Grace Kiringa: Co-Investigator Chandaria Health Centre Dagoretti, Dagoretti sub-county, Nairobi; The Centre has adequate facilities and staff to conduct clinical trials . The laboratory tests will be referred to Lancet Laboratories in Nairobi and the TCD tests will be performed in Nairobi. </p>\n<p>\n Site 8503 – PI Videlis Nduba - Siaya County Referral Hospital, Siaya County.  Dr. Grace Kiringa: Co-Investigator.  Kenya Medical Research Institute (KEMRI) has a Clinical Research Annex at the Siaya County Referral Hospital.  This modern research at has the capacity to conduct Phase I to Phase III studies.  There are adequate facilities and qualified staff, including nurses and pharmacist to conduct clinical trials. The IP will be stored in the Clinical Research Annex and laboratory tests will be referred to the Lancet Laboratory Branch in Kisumu.  Transcranial Doppler studies will be performed in Kisumu.  Patients needing inpatient medical treatment will be admitted at the Siaya County referral Hospital. </p>\n<p>\n Site 8504 - The Kondele Children’s Hospital is designed for large clinical trials and has a full clinical laboratory including microbiology capability. The hospital is a KEMRI facility managed in collaboration with Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH).  The Sickle Cell study will be conducted at KEMRI/WRP sites, recruitment will occur at the Kondele Children’s Hospital within (JOOTRH). The study will be carried out at the KEMRI/WRP Kondele Children’s Hospital in Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH). The Kondele Children’s Hospital at the Jaramogi Oginga Odinga Teaching and Referral Hospital is located adjacent to the KEMRI/WRP Kisumu headquarters in Kondele within Kisumu East district.</p>\n<p>\n The Kondele Children’s Hospital study site at JOOTRH will be staffed by KEMRI qualified research personnel. The site has a pharmacy, vaccination area, clinical assessment area, data entry area, internal quality control and registration area and space where monitoring can be done. The unit completed a study on prasugral (antiplatelet agent) in children < 18 years.</p>\n
      • other_details_explanation<p>\n Sickle cell disease is primarily found in Africa where it is endemic in certain countrie, Kenya included.   Patients with SCD suffer chronic pain and reduced quality of life due to recurrent hospitalizations, grave complications  from the disease including organ damage, stroke and long term disabilities.  Although hydroxyurea has been found to have ameliorating effects on the disease, response in some patients is suboptimal and in some cases there are serious adverse effects.  Blood transfusions are also associated with various hazards.  New treatment modalities are therefore urgently needed and these options should also be validated in this region.</p>\n
      • other_details_regulatory_notapproved<ol>\n <li>\n Submission to CSR Centre for Respiratory Diseases Research, KEMRI, Ethics Review Committee has been made for the KEMRI CGHR site at the Siaya Country Referral Hospital and  Chandaria Health Centre in Dagoretti.  Application submitted on 24 March 2016.</li>\n <li>\n Submission to Kenya Medical Research Institute (KEMRI) SERU Ethics Review Committee has been made for the Kondele Children’s Hospital, KEMRI – Centre for Clinical Research.  Response to initial application received on 26 May 2016.  The PI for the site is re-submitting response to the corrections/clarifications sought.</li>\n</ol>\n
      • other_details_regulatory_approved<p>\n List of Competent Authorities which the application has been submitted and details of decisions:</p>\n<ol>\n <li>\n Canada: Competent Authority-  Health Canada Holland Cross, Tower B, 5th floor 1600 Scott Street 3105A, Ottawa, Ontario K1AOK9. Date of submission: 03-July-2014 . Approved 30-July-2014. One site open for enrollement  </li>\n <li>\n South Africa: The Registrar of Medicines,  Department of Health, Medicines Control Council, Private Bag X828, Pretoria 0001, REPUBLIC OF SOUTH AFRICA. Submission date:  08-July -2014.  Approved 21-Oct-2014. Two sites open for enrollement </li>\n <li>\n United Kingdom: Medicines and Healthcare products Regulatory Agency (MHRA), Information Processing Unit, Area 6, 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ. Submission date: 06-June -2014 . Approved 23-July-2014. Two sites open for enrollement </li>\n <li>\n United States: Food and Drug Administration, Center for Drug Evaluation and Research, Division of Hematology Products, 5901-B Ammendale Road, Beltsville, MD 20705-1266. Approval not required.  Four sites haave EC approval. </li>\n <li>\n Kenya:  EC approval from Gertrude's Children's Hospital - Ethics Review Board. Submission on 11 March 2016. Approved 15 June 2016</li>\n</ol>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_durationPart A - 5 weeks; Part B will not be performed in Kenya
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states10 (ten)
      • number_of_sitesFour (4)
      • multi_country_listCanada, UK, USA, Lebanon, Egypt, South Africa, Kenya, Ghana, Italy, Turkey
      • data_monitoring_committeeYes
      • total_enrolment_per_siteCompetitive enrollment\nMinimum per site = 1 (one); Maximum per site = 9 (nine)
      • total_participants_worldwideMinimum=36 (thirty-six); Maximum =50 (fifty)
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyThe subjects are individuals with sickle cell disease (SCD) and these are expected to be patients at various times during their lives. The majority are on follow-up for their disease. Females (if after menarche) must be willing to use a highly effective method of contraception which results in a low failure rate (i.e. less than 1% per year). Children less than 18 years will be recruited and their parents/guardians will be asked to provide consent. Those over 12 years will be asked to provide assent in addition.
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameJessie
      • investigator1_middle_nameNyokabi
      • investigator1_family_nameGithanga
      • investigator1_qualificationMBChB, MMed (Pathology)
      • investigator1_professional_addressCollege of health Sciences (KNH), University of Nairobi, P. O. Box 19676 - 00202 Nairobi, Kenya
      • investigator1_telephone+254-721-245721
      • investigator1_emailjgithanga3@gmail.com
      • organisations_transferred_Yes
      • number_participants12 (twelve)
      • notification<p>\n Kind request for an expidited review.  Payment of a toyal of USD 2,000 has been made to facilitate this.</p>\n
      • approval_date19-09-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted20-07-2016
      • 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)
      • modified2017-05-26 16:44:26
      • created2016-06-29 12:40:52
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id334
        • application_id511
        • given_nameJessie
        • middle_nameNyokabi
        • family_nameGithanga
        • qualificationMBChB, MMed (Pathology)
        • professional_addressCollege of health Sciences (KNH), University of Nairobi, P. O. Box 19676 - 00202 Nairobi, Kenya
        • telephone+254-721-245721
        • emailjgithanga3@gmail.com
        • created2016-06-29 12:51:47
        • modified2016-07-20 12:55:52
      • 1(array)
        • id335
        • application_id511
        • given_nameVidelis
        • middle_name
        • family_nameNduba
        • qualificationMBChB, MPH, PhD
        • professional_addressP.O Box 1578, Kisumu, Kenya, Post code 40100
        • telephone+254 -724 –522474
        • emailvnduba@kemricdc.org
        • created2016-06-29 13:24:17
        • modified2016-07-20 12:55:52
      • 2(array)
        • id336
        • application_id511
        • given_nameBernhards
        • middle_nameRagama
        • family_nameOgutu
        • qualificationMBChB, Med (Paediatrics), PhD (clinical Pharmacology)
        • professional_addressP.O. Box 54840, 00200, Nairobi, 00200, Kenya
        • telephone+254-733-812613
        • emailogutu6@gmail.com
        • created2016-06-29 13:24:17
        • modified2016-07-20 12:55:52
    • SiteDetail(array)
      • 0(array)
        • id398
        • application_id511
        • county_id47
        • site_nameGertrude’s Children’s Hospital
        • physical_addressMuthaiga Road, Off Thika Superhighway, Muthaiga, NAIROBI
        • contact_detailsTel: 020 720600 Nairobi. P. O. Box 42325 – 00100, NAIROBI, Kenya.
        • contact_personProf Jessie Githanga
        • site_capacity(null)
        • misc(null)
        • created2016-06-29 12:51:47
        • modified2016-07-20 12:55:52
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id408
        • application_id511
        • county_id47
        • site_nameKemri CRDR research center at Chandaria Health Centre Dagoretti
        • physical_addressKikuyu/Dagoretti Road, Dagoretti, Nairobi
        • contact_detailsP.O. Box: 43678, 00100 Nairobi GPO, Nairobi, Kenya. Tel 0790484654
        • contact_personDr Videlis Nduba
        • site_capacity(null)
        • misc(null)
        • created2016-07-13 20:17:13
        • modified2016-07-20 12:55:52
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 2(array)
        • id409
        • application_id511
        • county_id41
        • site_nameClinical Research Annex at the Siaya County Referral Hospital
        • physical_addressHospital Road, Mulaha, (Within Siaya town) Township location, Karemo division, Siaya County. Siaya
        • contact_detailsP.O Box 144, Siaya 40600. TEL +254 724 278 886
        • contact_personDr Videlis Nduba
        • site_capacity(null)
        • misc(null)
        • created2016-07-13 20:30:16
        • modified2016-07-20 12:55:52
        • County(array)
          • id41
          • county_nameSiaya
          • created2012-06-15 10:26:56
          • modified2012-06-15 10:26:56
      • 3(array)
        • id410
        • application_id511
        • county_id42
        • site_nameKondele Children’s Hospital, KEMRI – Centre for Clinical Research
        • physical_addressKondele Children\'s Hospital, Jaramogi Oginga Odinga Teaching and Referral Hospital grounds, Kisumu-Kakamega Road, Kisumu Town
        • contact_detailsTEL: Box 54-40100, Kisumu
        • contact_personDr Bernhards Ogutu
        • site_capacity(null)
        • misc(null)
        • created2016-07-13 20:51:31
        • modified2016-07-20 12:55:52
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id266
        • application_id511
        • sponsorAstraZeneka
        • sponsor_type(null)
        • contact_personLisa Harlin
        • addressAstraZeneca R&D Mölndal SE-431 83 Mölndal, Sweden
        • telephone_numberTel: +46 31 706 10 91
        • fax_number
        • cell_number+46 70 259 19 53
        • email_addresslisa.harlin@astrazeneca.com
        • created2016-06-29 12:51:47
        • modified2016-07-20 12:55:52
  • 3(array)
    • Application(array)
      • id508
      • user_id56
      • trial_status_id6
      • abstract_of_study<p>\n We will prospectively enroll up to 350 young women who choose to initiate PrEP at two clinical sites in Kenya. We will use wireless adherence monitoring to understand PrEP adherence behavior, as well as patterns of PrEP discontinuation (and re-initiation), in this cohort. We will randomize half of the women to SMS reminders to determine its impact on adherence. We will assess the technical function, acceptability, cost, and validity of the next generation Wisepill device coupled to SMS reminders, thus helping to determining the potential for this technology to assess and support PrEP adherence in future studies and potentially clinical care. Additionally, we will longitudinally assess HIV risk behaviors and perceptions using SMS in all women to determine how well risk for HIV infection is aligned with adherence (a concept called prevention-effective adherence). The study will involve a combination of quantitative and qualitative methods</p>\n
      • study_title<p>\n Next generation real-time monitoring for PrEP adherence in young adult women.</p>\n
      • laymans_summary<p>\n Real-time electronic monitoring is the optimal approach for understanding patterns of adherence, which is critical for determining if adherence to daily oral pre-exposure prophylaxis (PrEP) aligns with an individual’s risk for HIV acquisition. Compared with earlier adherence measurement devices, next generation Wisepill technology offers significant innovations in data storage and transmission reliability, cost, and usability and is ready for implementation in resource-limited settings. Coupling Wisepill monitoring to SMS adherence reminders has great potential to support adherence at the precise time it is needed. Real-time strategies may be particularly important for young women- a population in need of self-controlled HIV prevention strategies, but one that has previously struggled with PrEP adherence. Triangulating weekly SMS measurement of sexual behavior with adherence may explain how PrEP can be used most effectively for HIV prevention (i.e., prevention-effective adherence). This protocol describes a longitudinal study of young Kenyan women at high risk for HIV who will be offered PrEP for up to two years. Adherence will be monitored in all women with the next generation Wisepill; half will be randomized to receive SMS reminders. The technical function, acceptability, cost, and validity of the next generation Wisepill device coupled to SMS reminders will be determined among this cohort of young Kenyan women. Additionally, SMS will be used for longitudinal assessment of risk perception and its alignment with PrEP adherence.</p>\n
      • short_titleMonitoring Pre-Exposure Prophylaxis for Young Adult Women ( (MPYA)
      • protocol_noECCT/16/09/02
      • version_no2.0
      • date_of_protocol19-04-2016
      • study_drugTENOFOVIR/ EMTRICITABINE TABLETS (TRUVADA)
      • disease_conditionPrEP ADHEREENCE
      • 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_nameTRUVADA
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressaachoka@kemri-ucsf.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_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantProf. Elizabeth Bukusi. P.O BOX 614-40100 Kisumu
      • declaration_date128-06-2016
      • declaration_principal_investigatorProf. Elizabeth Bukusi. P.O BOX 614-40100 Kisumu
      • declaration_date228-06-2016
      • placebo_presentNo
      • study_objectives<p>\n Aim 1. Use the next generation Wisepill device in a cohort of young HIV-uninfected Kenyan women initiating PrEP to a) measure real-time adherence and b) determine the impact of SMS reminders on adherence. We will monitor adherence among all women with Wisepill. We will randomize half to receive daily SMS reminders with the option of switching to SMS reminders only as triggered by missed doses; the other half will receive no SMS reminders. There will be two primary outcomes for this aim. First, we will determine enacted adherence (i.e., pill taking) and persistence (i.e., continuation of PrEP over time) as determined by Wisepill from initiation of PrEP use (when adherence patterns are often established) through 24 months of use, comparing those randomized or not to SMS reminders. Second, we will compare dried blood spot (DBS) tenofovir-diphosphate levels between the two groups at multiple time points. With both outcomes, we will be assessing the synergy of SMS reminders coupled to real-time monitoring.</p>\n<p>\n Aim 2. Determine the technical function, acceptability, cost, and validity of the next generation Wisepill device coupled to SMS reminders. We will measure data transmission reliability, battery life, and other technical features through the two-year cohort study. We will assess acceptability and usability of our strategy via quantitative surveys in all women, as well as qualitative interviews in about 50 women. We will additionally assess costs and ease of use with a time and motion study. Using these cost estimates and adapting an existing mathematical model of HIV transmission, we will estimate the cost-effectiveness of Wisepill plus the SMS reminders per HIV case averted. Adherence validity will be determined by comparing the Wisepill data with DBS tenofovir levels as measured in Aim 1. Discrepancies between the two measures will be explored through qualitative interviews at the conclusion of the study.</p>\n<p>\n Aim 3. Triangulate Wisepill adherence data with weekly assessment of HIV risk behaviors and perceptions, to measure prevention-effective adherence. After the first 6 months of PrEP use (i.e., when initial decisions about PrEP may start to change), we will send all women a weekly SMS survey asking about recent sexual behavior, use of alternate HIV prevention tools, subjective HIV risk, and perception of their PrEP adherence. We will explore the overlap of perceptions and behaviors and PrEP adherence, through quantitative surveys in all women and qualitative interviews in about 50 women. Our goal is to measure dynamic changes in HIV risk and perception of risk or other motivators for HIV prevention that may lead to PrEP discontinuation (appropriately or inappropriately). We will use these SMS surveys to quantify prevention-effective adherence in young women at risk for HIV infection (individually and for the cohort overall).</p>\n
      • principal_inclusion_criteria<p>\n • Female • HIV-uninfected (as determined by Kenya national testing algorithms) • Age 18-24 years • Wanting to start PrEP with an initial recommendation of 6 months of use • Clinically safe to receive PrEP, in accordance with CDC guidelines:  Creatinine clearance >60 mL/min  Not infected with hepatitis B  No other medical condition that in the discretion of the site investigator would make participation unsafe or complicate the goals of the study • Sexually active (defined as vaginal or anal sex) within the last 3 months • At high risk for HIV infection based on a score of >5 [46] or being in an HIV serodiscordant relationship • Not pregnant • Owns a personal cell phone (not shared) compatible with the technology used in the study and the ability to charge it • Intending to stay in the area for at least the next year</p>\n
      • principal_exclusion_criteria<p>\n Exclusion • Unable to provide consent • Breast-feeding (Truvada is not currently approved for use during breast-feeding) • Concurrent participation in another research study that may influence adherence to PrEP and/or interfere with the procedures of this study.</p>\n
      • primary_end_points<p>\n We will assess the technical function, acceptability, cost, and validity of the next generation Wisepill device coupled to SMS reminders, thus helping to determining the potential for this technology to assess and support PrEP adherence in future studies and potentially clinical care. Additionally, we will longitudinally assess HIV risk behaviors and perceptions using SMS in all women to determine how well risk for HIV infection is aligned with adherence (a concept called prevention-effective adherence</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyAdherence monitoring
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n Principal investigator -1</p>\n<p>\n Co-Principal Investigators-1</p>\n<p>\n Study coordinator-1</p>\n<p>\n Research Assistants-2</p>\n<p>\n Laboratory technologist-1</p>\n<p>\n Pharmaceutical Technologist-1</p>\n<p>\n Receptionist-1</p>\n<p>\n Data manager-1</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n The trial will be conducted in two sites in Kenya</p>\n
      • other_details_regulatory_notapproved<p>\n NONE</p>\n
      • other_details_regulatory_approved<p>\n 1. PARTNERS HUMAN RESERACH COMMITTEE IRB</p>\n<p>\n 2. uNIVERSITY OF WASHINGTON IRB</p>\n
      • other_details_regulatory_rejected<p>\n NONE</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration24 Months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites2
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site175
      • total_participants_worldwide350
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • 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_nameJessica Haberer
      • investigator1_middle_name
      • investigator1_family_nameHaberer
      • investigator1_qualificationMD, MS
      • investigator1_professional_addressPartners Human Research Committer
      • investigator1_telephone116 Huntington Avenue,Suite 1002
      • investigator1_emailjhaberer@partners.org
      • organisations_transferred_No
      • number_participants350
      • notification
      • approval_date27-09-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted18-05-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2020-08-19 18:59:29
      • created2016-06-28 13:19:16
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id332
        • application_id508
        • given_nameProf. Elizabeth Anne Bukusi
        • middle_name
        • family_nameBukusi
        • qualificationBachelor of Medicine and Bachelor of surgery/Masters of Medicine in Obstetrics and Gynecology
        • professional_addressP.O BOX 614 -40100 KISUMU
        • telephone(254) (020) 2722541 (Nairobi) 254 57 2021036
        • emailebukusi@kemri.org
        • created2016-06-28 13:57:51
        • modified2020-05-18 18:53:29
      • 1(array)
        • id333
        • application_id508
        • given_nameDr. Stella Njuguna
        • middle_name
        • family_nameNjuguna
        • qualificationB.Pharm/ MPH
        • professional_addressP.O BOX 614 -40100 KISUMU
        • telephone+254 722422977
        • emailnjugunastella@gmail.com
        • created2016-06-28 14:04:29
        • modified2020-05-18 18:53:29
    • SiteDetail(array)
      • 0(array)
        • id396
        • application_id508
        • county_id42
        • site_nameKISUMU SITE
        • physical_addressAGOI STREET
        • contact_detailsP.O Box 614-40100 KISUMU
        • contact_personDr. Stella Njuguna
        • site_capacity(null)
        • misc(null)
        • created2016-06-28 13:57:51
        • modified2020-05-18 18:53:29
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id264
        • application_id508
        • sponsorUniversity of Washington
        • sponsor_typeOthers
        • contact_personJared Beaten
        • addressP.O BOX 359470
        • telephone_number206-543-0098
        • fax_number206-543-9218
        • cell_number206-520-3831
        • email_addressCWSCOV@UW.edu
        • created2016-06-28 13:57:51
        • modified2020-05-18 18:53:29
  • 4(array)
    • Application(array)
      • id872
      • user_id480
      • trial_status_id(null)
      • abstract_of_study<p>\n Rationale: Integrase strand transfer inhibitor (INSTI)-based ARV regimens, especially those including DTG, have emerged as highly attractive regimens for ART-naïve and ART-experienced patients. There is limited data on the performance and emergence of resistance to TLD in diverse settings. Understanding the risks and benefits of TLD rollout is critical to monitor programmatic and clinical outcomes for patients initiating or transitioning to TLD.</p>\n<p>\n Objectives: The primary objective of the study is to estimate the proportion of participants achieving virologic success (HIV-1 RNA ≤1000 copies/mL) and the proportion with new DTG resistance mutations at 6 months of TLD therapy with or without Rifampicin-contianing tuberculosis (TB) treatment. The secondary objectives include: To describe treatment outcomes at 6, 12, 24, and 36 months after starting TLD according to the US Food and Drug Administration (FDA) Snapshot algorithm. To assess the long-term durability of TLD (up to 36 months) in suppressing viremia. To assess drug resistance and accumulation of drug resistance mutations over time. To describe the frequency of toxicities leading to discontinuation of the TLD regimen. To assess change in quality of life after starting TLD. To describe the frequency of clinical events relevant for TLD.</p>\n<p>\n Overall Design: This is an observational, longitudinal prospective cohort study to assess therapeutic efficacy and emergence of HIV drug resistance following switching to TLD from first-line (Group 1) or second-line (Group 2) antiretroviral therapy (ART), or start of concomitant TLD and rifampicin (RIF)-containing tuberculosis (TB) treatment (group 3), or upon ART initiation (group 4). Each participant will be followed for 36 months.</p>\n<p>\n Target Population: HIV-infected adults and adolescents (>30 kg, ≥10 years of age) initiating or switching to TLD and receiving care through a President’s Emergency Plan for AIDS Relief (PEPFAR)-supported treatment program. Across all sites, approximately 1350 participants: 540 in Group 1 with the goal of at least 180 in Group 1a, 540 in Group 2 with the goal of at least 180 in Group 2a, 90 in Group 3, and 180 in Group 4. The Kisumu site will contribute approximately 100 participants across all recruitment groups.</p>\n<p>\n Intervention: This being an observational study, no treatments are provided through the study/trial site. Qualifying treatment (initiated within 7 days after study entry): For Groups 1, 2, and 4 - Co-formulated tenofovir disoproxil fumarate 300 mg/lamivudine 300 mg/dolutegravir 50 mg (TLD) taken once daily. For Group 3 - During TB treatment and for 2 weeks following completion of rifampicin-containing TB treatment, TLD taken once daily with an additional daily dose of DTG 50 mg such that DTG is taken twice daily. TB treatment will follow WHO Guidelines.</p>\n<p>\n Analysis: The primary objective regarding virologic success rates will be addressed by computing the proportion of participants in each study group/subgroup for whom virologic success has been achieved (based on the primary outcome measure) together with the associated two-sided 95% Wald CI. The primary objective regarding drug resistance will be addressed by computing the cumulative proportion of participants in each study group with virologic failure and new DTG drug resistance mutations together with the associated two-sided 95% CI.</p>\n
      • study_title<p>\n Observational Cohort to Assess Therapeutic Efficacy and Emergence of HIV Drug Resistance Following Initiation of Tenofovir-Lamivudine-Dolutegravir (TLD) for First- or Second-Line ART or with Rifampicin-Containing TB Treatment</p>\n
      • laymans_summary<p>\n This is an observational study to assess treatment efficacy and emergence of HIV drug resistance following initiation of TLD and rifampicin‐containing tuberculosis treatment. To the greatest extent possible, participants will be managed according to local standards of care provided at the local health facilities. Participants will be divided into four study groups for enrollment:</p>\n<p>\n Group 1: Participants switching to TLD from a first‐line ARV regimen.</p>\n<p>\n Group 2: Participants switching to TLD from a second‐line ARV regimen.</p>\n<p>\n Group 3: Participants initiating concomitant TLD and RIF‐containing TB treatment.</p>\n<p>\n Group 4: ART‐naïve participants initiating therapy with TLD. Each participant will be followed for 36 months, with study specific evaluations at 3, 6, 12, 18, 24 30 and 36 months. The study targets 1350 participants across all participating sites, with an estimated 100 participants from the Kisumu site.</p>\n
      • short_titleA5381
      • protocol_noECCT/20/05/03
      • version_no1.0
      • date_of_protocol08-04-2019
      • study_drugTenofovir-Lamivudine-Dolutegravir
      • disease_conditionHIV
      • product_type_biologicals1
      • product_type_proteins1
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones1
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresseodipo@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_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan0
      • applicant_contractual_agreement0
      • declaration_applicantDr. Victor Mudhune
      • declaration_date102-05-2020
      • declaration_principal_investigatorDr. Victor Mudhune
      • declaration_date202-05-2020
      • placebo_presentNo
      • study_objectives<p>\n The primary objective of the study is to estimate the proportion of participants achieving virologic success (HIV-1 RNA ≤1000 copies/mL) and the proportion with new DTG resistance mutations at 6 months of TLD therapy with or without Rifampicin-contianing tuberculosis (TB) treatment.</p>\n<p>\n The secondary objectives include: To describe treatment outcomes at 6, 12, 24, and 36 months after starting TLD according to the US Food and Drug Administration (FDA) Snapshot algorithm. To assess the long-term durability of TLD (up to 36 months) in suppressing viremia. To assess drug resistance and accumulation of drug resistance mutations over time. To describe the frequency of toxicities leading to discontinuation of the TLD regimen. To assess change in quality of life after starting TLD. To describe the frequency of clinical events relevant for TLD.</p>\n
      • principal_inclusion_criteria<p>\n I. Receiving care at a PEPFAR-supported site.</p>\n<p>\n II. Documentation of HIV-1 infection acceptable to the local PEPFAR-supported program to allow ART to be initiated or continued.</p>\n<p>\n III. Age >10 years.</p>\n<p>\n IV. Ability and willingness of participant or legal guardian/representative to provide informed consent to participate in the study.</p>\n<p>\n V. Expectation that the participant will receive care within the local PEPFAR- supported program and will be able to be followed for study evaluations for at least 6 months and ideally for 36 months.</p>\n<p>\n VI. Group 1 participants: Receipt of an NNRTI-containing first-line ARV regimen from a PEPFAR supported clinic for at least 6 consecutive calendar months prior to study entry. NOTE: ARV treatment gaps are allowed, but treatment gaps should not exceed 14 consecutive days in the 6 calendar months prior to study entry. Group 2 participants: Receipt of a boosted PI-containing second-line ARV regimen from a PEPFAR-supported clinic for at least 6 consecutive calendar months prior to study entry. NOTE: ARV treatment gaps are allowed, but treatment gaps should not exceed 14 consecutive days in the 6 calendar months prior to study entry. Group 4 participants: No current or prior ARV treatment. NOTE: Women who received ARV regimens only during pregnancy and/or breastfeeding for prevention of mother-to-child transmission but who have not taken any ARV drugs for at least 6 calendar months immediately prior to study entry will be allowed.</p>\n<p>\n VII. For Group 1, 2, and 4 participants, expected initiation of TLD taken once daily within 7 days after study entry. NOTE: Group 1, 2, and 4 participants may not be on, or expected to start, RIF containing TB treatment at the time of study entry.</p>\n<p>\n VIII. For Group 3 participants already on RIF-containing TB treatment but not on TLD at study entry, expected initiation of TLD taken once daily with an additional daily dose of DTG 50 mg. This must be started within 7 days after study entry AND within 56 days after the start of RIF-containing TB treatment. These participants may be ART-naïve or may be switching from a first- or second-line ART regimen. NOTE: For ART-naïve participants who start RIF-containing TB treatment first and then start TLD at a later date, screening must occur within 14 days before the intended TLD start date.</p>\n<p>\n IX. For Group 3 participants not already on RIF-containing TB treatment but already on TLD at study entry, receipt of TLD for at least 6 consecutive calendar months prior to study entry AND expected initiation of RIF-containing TB treatment within 7 days after study entry.</p>\n<p>\n X. For Group 3 participants not already on RIF-containing TB treatment or TLD at study entry, expected initiation of TLD and RIF-containing TB treatment within 7 days after study entry. These participants may be ART-naïve or may be switching from a first- or second-line ART regimen.</p>\n
      • principal_exclusion_criteria<p>\n I. Weight ≤30 kg.</p>\n<p>\n II. For participants already on ART in Groups 1, 2, and 3, known to have had an ART interruption encompassing the entire 14 day window (≥14 consecutive days) immediately prior to study entry.</p>\n<p>\n III. For Group 3, if a participant is already taking TLD at the time of study entry, HIV- 1 RNA >1000 copies/mL within the past 9 months while taking TLD with no subsequent HIV-1 RNA ≤1000 copies/mL.</p>\n<p>\n IV. Prior enrollment in any group in this study. V. For Group 3 participants, already on concomitant TLD and RIF-containing TB treatment prior to study entry.</p>\n
      • primary_end_points<p>\n For Groups 1, 2, and 4: Virologic success, defined as suppression of plasma HIV-1 RNA to ≤1000 copies/mL, at 6 months after starting TLD. This will be based on the measurement closest to exactly 6 months (i.e., 183 days) aftercthe date of start of TLD, within the window of 6 months ±3 months (specifically 92 to 274 days, inclusive). For participants experiencing virologic failure (HIV-1 RNA >1000 copies/mL) at 6 months after starting TLD, new DTG resistance mutations defined as those present at the time of virologic failure confirmation that were not present at the time of starting TLD. For Group 3: Virologic success, defined as suppression of plasma HIV-1 RNA to ≤1000 copies/mL, at the end of concomitant TLD (including an additional daily dose of DTG 50 mg such that DTG is taken twice daily) and RIF-containing TB treatment. This will be the measurement closest to the end of concomitant treatment within the window of 4 weeks (28 days) before the end to 6 months (183 days) after the end, inclusive. For participants experiencing virologic failure (HIV-1 RNA >1000 copies/mL) at the end of concomitant TLD (including an additional daily dose of DTG 50 mg such that DTG is taken twice daily) and RIF-containing TB treatment, new DTG resistance mutations defined as those present at the time of the virologic failure confirmation that were not present at the time of starting TLD.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyHIV Drug Resistance
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyObservational Cohort to Assess Therapeutic Efficacy and Emergence of HIV Drug\nResistance
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n the study will have approximately 13 staff as follows;</p>\n<p>\n 1 principal Investigator, 1 study coordinator, 1 medical fficer, 1 Clinical Officer, 2 nurses, 2 data analysts, 1 QA officer, 1 regulatory affairs officer, 3 laboratory staff.</p>\n<p>\n This is subject to change once the study starts</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n A5381 will be open to ACTG clinical research sites (CRSs) in Haiti, Kenya, Malawi, South Africa, Uganda, and Zimbabwe</p>\n
      • other_details_regulatory_notapproved<p>\n None.</p>\n
      • other_details_regulatory_approved<p>\n Approval obtained by SERU and Jaramogi Odinga Oginga Teaching and Referral Hosptal.</p>\n<p>\n Site is not privy to Regulatory information from other countries.</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration1 year
      • design_controlled_randomisedNo
      • 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_comparatorn/a
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKisumu Clinical Research Center
      • single_site_physical_addressKEMRI CDC Clinical Research Center JOOTRH off Kakamega Road
      • single_site_contact_personVictor Mudhune
      • single_site_telephone+254722687430
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states8
      • number_of_sites
      • multi_country_listDurban International CRS\nFamily Clinical Research Unit (FAM-CRU) CRS\nGHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO – IMIS) CRS\nJoint Clinical Research Centre (JCRC)/Kampala CRS\nKenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS\nLes Centres Gheskio (Gheskio-INLR) CRS\nMalawi CRS\nUniversity of Cape Town CTU\nUniversity of the Witwatersrand Helen Joseph (WITS HJH) CRS
      • data_monitoring_committeeYes
      • total_enrolment_per_site100
      • total_participants_worldwide1350
      • 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_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameN/A
      • investigator1_middle_name
      • investigator1_family_nameN/A
      • investigator1_qualificationn/a
      • investigator1_professional_addressN/A
      • investigator1_telephoneN/A
      • investigator1_emailvmudhune@kemricdc.org
      • organisations_transferred_No
      • number_participants100
      • notification<p>\n files have been shared on the checklist section</p>\n
      • approval_date21-08-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted27-08-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe application has been approved by the expert committee
      • final_report<p>\n Study not implemented on site</p>\n
      • implication_results<p>\n Study nt implemented on site</p>\n
      • quantity_importedn/a
      • quantity_dispensedn/a
      • quantity_destroyedn/a
      • quantity_exportedn/a
      • balance_siten/a
      • final_date0000-00-00
      • modified2021-05-19 08:58:04
      • created2020-04-15 14:01:54
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id536
        • application_id872
        • given_nameVictor
        • middle_name
        • family_nameMudhune
        • qualificationPharmacist
        • professional_addressPO BOX 1578 Kisumu
        • telephone0722687430
        • emailVmudhune@kemricdc.org
        • created2020-04-15 14:06:10
        • modified2020-08-27 15:49:13
    • SiteDetail(array)
      • 0(array)
        • id746
        • application_id872
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2020-04-15 14:06:10
        • modified2020-08-27 15:49:13
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id424
        • application_id872
        • sponsorNational Institute of Allergy and Infectious Diseases
        • sponsor_typeResearch Institution
        • contact_person
        • addressNIAID Office of Communications and Government Relations 5601 Fishers Lane, MSC 9806
        • telephone_numberLocal: 301-496-5717
        • fax_number301-402-3573
        • cell_numbern/a
        • email_addressocpostoffice@niaid.nih.gov
        • created2020-04-15 14:06:10
        • modified2020-08-27 15:49:13
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(array)
    • approved2
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
  • 7DebugTimer
  • 8Toolbar
  • 9HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

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

Included Files

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