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    • Application(array)
      • id195
      • user_id613
      • trial_status_id5
      • abstract_of_study<p>\n Acquired immuno deficiency syndrome related Kaposi’s sarcoma (AIDS-KS) occurs in<br />\n persons who are co-infected with HIV-1 and human herpes virus 8 (HHV-8 or KSHV).<br />\n Although highly active ART alone may lead to regression of limited-stage (T0) AIDSKS,<br />\n patients with advanced or rapidly progressive AIDS-KS are usually treated with<br />\n concomitant ART and chemotherapy. While a number of single chemotherapeutic agents<br />\n and drug combinations have proven effective in inducing regression of AIDS-KS, the<br />\n most effective regimens to use in combination with ART have not been well defined,<br />\n because many of the drugs used to treat KS were tested prior to the introduction of highly<br />\n active ART. Current Kenya ministry of health guidelines recommends the use of<br />\n vincristine and bleomycin with or without non liposomal doxorubicin. Because there is<br />\n no single chemothepeutic agent that has proven superior to others in combination with<br />\n ART and because availability of chemotherapeutic agent and the current standards for<br />\n treatment of AIDS KS differ in different resource limited settings, a randomized<br />\n comparison of PTX with either BV or oral ET is justified. The primary objective of this<br />\n study is to compare the clinical efficacy of two regimens, oral etoposide plus ART and<br />\n Bleomycin vincristin plus ART, to Paclitaxel plus ART for initial treatment of advanced<br />\n stage AIDS-KS. This is a prospective, randomized, active- controlled clinical trial. The<br />\n participants (male and female) must be 18 years and above with documented HIV-1<br />\n infection and must have a biopsy diagnostic of KS. They must not have used radiation<br />\n and chemotherapy treatment for KS, are currently not receiving ART or are pregnant and<br />\n they must also have advanced KS stage T1. At study entry participants will be<br />\n randomized 1:1:1 to oral etoposide (ET) plus antiretroviral therapy (arm 1A), bleomycin<br />\n and vincristine (arm 1B) plus ART, or Paclitaxel(PTX) plus ART (arm 1C). The Kericho<br />\n site will recruit 40-60 participants from Kericho District hospital and nearby health<br />\n facilities. The site accrual will be approximately 4 participants per month; hence<br />\n estimated duration of accrual of 10-15 months. Participants will be followed for 5-7<br />\n years depending on the randomization or assignment to the last step they enter. Scant data<br />\n is available to guide the optimal use of chemotherapy in combination with ART. Results<br />\n from this study will try to define the potential benefits of adjunctive chemotherapy in<br />\n treatment of advanced<br />\n KS in the era of HAART and will inform on treatment guidelines.</p>\n
      • study_title<p align=\"center\">\n <strong>A Randomized Comparison of Three Regimens of Chemotherapy with Compatible Antiretroviral Therapy for Treatment of Advanced AIDS-KS in Resource-Limited Settings</strong></p>\n
      • laymans_summary<p>\n Acquired immuno deficiency syndrome related Kaposi’s sarcoma (AIDS-KS) occurs in<br />\n persons who are co-infected with HIV-1 and human herpes virus 8 (HHV-8 or KSHV).<br />\n Although highly active ART alone may lead to regression of limited-stage (T0) AIDSKS,<br />\n patients with advanced or rapidly progressive AIDS-KS are usually treated with<br />\n concomitant ART and chemotherapy. While a number of single chemotherapeutic agents<br />\n and drug combinations have proven effective in inducing regression of AIDS-KS, the<br />\n most effective regimens to use in combination with ART have not been well defined,<br />\n because many of the drugs used to treat KS were tested prior to the introduction of highly<br />\n active ART. Current Kenya ministry of health guidelines recommends the use of<br />\n vincristine and bleomycin with or without non liposomal doxorubicin. Because there is<br />\n no single chemothepeutic agent that has proven superior to others in combination with<br />\n ART and because availability of chemotherapeutic agent and the current standards for<br />\n treatment of AIDS KS differ in different resource limited settings, a randomized<br />\n comparison of PTX with either BV or oral ET is justified. The primary objective of this<br />\n study is to compare the clinical efficacy of two regimens, oral etoposide plus ART and<br />\n Bleomycin vincristin plus ART, to Paclitaxel plus ART for initial treatment of advanced<br />\n stage AIDS-KS. This is a prospective, randomized, active- controlled clinical trial. The<br />\n participants (male and female) must be 18 years and above with documented HIV-1<br />\n infection and must have a biopsy diagnostic of KS. They must not have used radiation<br />\n and chemotherapy treatment for KS, are currently not receiving ART or are pregnant and<br />\n they must also have advanced KS stage T1. At study entry participants will be<br />\n randomized 1:1:1 to oral etoposide (ET) plus antiretroviral therapy (arm 1A), bleomycin<br />\n and vincristine (arm 1B) plus ART, or Paclitaxel(PTX) plus ART (arm 1C). The Kericho<br />\n site will recruit 40-60 participants from Kericho District hospital and nearby health<br />\n facilities. The site accrual will be approximately 4 participants per month; hence<br />\n estimated duration of accrual of 10-15 months. Participants will be followed for 5-7<br />\n years depending on the randomization or assignment to the last step they enter. Scant data<br />\n is available to guide the optimal use of chemotherapy in combination with ART. Results<br />\n from this study will try to define the potential benefits of adjunctive chemotherapy in<br />\n treatment of advanced<br />\n KS in the era of HAART and will inform on treatment guidelines.</p>\n
      • short_titleAdvanced Kapsosis Sarcoma Chemotherapy Regimens
      • protocol_noECCT/13/07/04
      • version_no2.0
      • date_of_protocol07-08-2012
      • study_drugetoposide, bleomycin sulfate, vincristine sulfate, paclitaxel (PTX), FTC/TDF (Truvada®), EFV (Stocrin®), and EFV/FTC/TDF (Atripla®).
      • disease_conditionHIV Associated Advanced Stage Kaposi\'s sarcoma
      • 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_nameetoposide, bleomycin sulfate, vincristine sulfate, paclitaxel (PTX), FTC/TDF (Truvada®), EFV (Stocrin®), and EFV/FTC/TDF (Atripla®).
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressgeoffrey.koskei@usamru-k.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd0
      • applicant_prev_data0
      • applicant_stability_data0
      • applicant_analysis_cert0
      • applicant_pictorial_sample0
      • applicant_gcp_training0
      • applicant_dsmb_charter0
      • applicant_detailed_budget0
      • applicant_indemnity_pi1
      • applicant_practice_license0
      • applicant_registration_ctr(null)
      • applicant_pan_african0
      • applicant_hard_copies(null)
      • applicant_signed_checklist0
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantGeoffrey Koskei
      • declaration_date125-07-2013
      • declaration_principal_investigatorFredrick K. Kirui
      • declaration_date225-07-2013
      • placebo_presentNo
      • study_objectives<p>\n To compare the effects of randomized treatment on serum levels of inflammatory cytokines and/or molecules associated with angiogenesis.</p>\n<p>\n To determine whether serum levels of cytokines and angiogenesis-associated molecules are associated with clinical response, immunological response (assessed by measuring CD4+ lymphocyte cell count), virological responses (assessed by measurement of HIV-1 and HHV8 viral load), and the development of IRIS.</p>\n<p>\n  </p>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n <font face=\"TimesNewRomanPSMT\">1. HIV-1 positive men and women </font><font face=\"TimesNewRomanPSMT\" lang=\"JA\">≥ </font><font face=\"TimesNewRomanPSMT\">18 years of age, with limited stage KS</font></p>\n<p>\n <font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\">2. Biopsy diagnostic of KS at any time prior to study entry.</font></font></p>\n<p>\n <font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\">3. Current KS stage T1 using ACTG criteria</font></font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\">4. A minimum of five indicator KS cutaneous marker lesions plus an additional two lesions </font><font face=\"TimesNewRomanPSMT\">greater or equal to 4x4 mm that are accessible for punch biopsy</font></font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\">5. CD4+ lymphocyte cell count obtained within 28 days prior to study entry at a DAIDS approved </font><font face=\"TimesNewRomanPSMT\">laboratory.</font></font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\">6. The following laboratory values obtained within 14 days prior to study entry:</font></font></font></p>\n<p align=\"LEFT\" style=\"margin-left: 40px;\">\n <font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"Symbol\">• </font><font face=\"TimesNewRomanPSMT\">Absolute neutrophil count (ANC) </font><font face=\"Symbol\" lang=\"JA\">≥ </font><font face=\"TimesNewRomanPSMT\">1000 cells/mm</font><font face=\"TimesNewRomanPSMT\" size=\"1\"><font face=\"TimesNewRomanPSMT\" size=\"1\">3</font></font></font></font></p>\n<p align=\"LEFT\" style=\"margin-left: 40px;\">\n <font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"Symbol\">• </font><font face=\"TimesNewRomanPSMT\">Hemoglobin </font><font face=\"Symbol\" lang=\"JA\">≥ </font><font face=\"TimesNewRomanPSMT\">9 g/dL</font></font></font></p>\n<p align=\"LEFT\" style=\"margin-left: 40px;\">\n <font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"Symbol\">• </font><font face=\"TimesNewRomanPSMT\">Platelet count </font><font face=\"Symbol\" lang=\"JA\">≥ </font><font face=\"TimesNewRomanPSMT\">100,000/mm</font><font face=\"TimesNewRomanPSMT\" size=\"1\"><font face=\"TimesNewRomanPSMT\" size=\"1\">3</font></font></font></font></p>\n<p style=\"margin-left: 40px;\">\n <font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"Symbol\">• </font><font face=\"TimesNewRomanPSMT\">Estimated creatinine clearance of </font><font face=\"TimesNewRomanPSMT\" lang=\"JA\">≥ </font><font face=\"TimesNewRomanPSMT\">60 mL/min</font></font></font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\">7. Female study volunteers of reproductive potential </font><font face=\"TimesNewRomanPSMT\"> must have a </font><font face=\"TimesNewRomanPSMT\">negative serum or urine pregnancy </font><b><font face=\"TimesNewRomanPS-BoldMT\">test with a sensitivity of at least 15-25 mIU/mL </font></b><font face=\"TimesNewRomanPSMT\">performed within 24 hours before initiating the protocol-specified medications.</font></font></font></font></font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\">8. All participants must agree not to participate in a conception process; </font><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\">If participating in sexual activity that could lead to pregnancy, the study volunteer must agree </font><font face=\"TimesNewRomanPSMT\">that two reliable forms of contraceptives will be used simultaneously while receiving </font><font face=\"TimesNewRomanPSMT\">protocol-specified medications, and for 12 weeks after stopping the medications</font></font></font></font></font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\">9. Karnofsky performance status </font><font face=\"TimesNewRomanPSMT\" lang=\"JA\">≥ </font><font face=\"TimesNewRomanPSMT\">60 within 28 days prior to entry.</font></font></font></font></p>\n<p>\n <font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\">10. Ability to swallow oral medications and adequate venous access.</font></font></font></font></font></p>\n<p>\n  </p>\n
      • principal_exclusion_criteria<p align=\"LEFT\">\n <font face=\"TimesNewRomanPSMT\">1. Current chronic, acute, or recurrent infections that are serious, in the opinion of the site </font><font face=\"TimesNewRomanPSMT\">investigator, for which the participant has not completed at least 14 days of therapy prior to </font><font face=\"TimesNewRomanPSMT\">study entry and/or is not clinically stable.</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\">2. Serious illness requiring systemic treatment and/or hospitalization within 14 days prior to </font><font face=\"TimesNewRomanPSMT\">entry.</font></font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\">3. Current or history of known pulmonary fibrosis, chronic obstructive pulmonary disease </font><font face=\"TimesNewRomanPSMT\">(COPD), emphysema, bronchiectasis, or diffuse or significant local radiographic interstitial </font><font face=\"TimesNewRomanPSMT\">infiltrates on chest x-ray (CXR) or computed axial tomography (CAT), that in the opinion of </font><font face=\"TimesNewRomanPSMT\">the investigator would exclude bleomycin use.</font></font></font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\">4. Oxygen saturation less than 90% and/or exercise desaturation greater than 4% within 14 days </font><font face=\"TimesNewRomanPSMT\">prior to study enrollment.</font></font></font></font></p>\n<p>\n <font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\">5. Grade </font><font face=\"TimesNewRomanPSMT\" lang=\"JA\">≥</font><font face=\"TimesNewRomanPSMT\">3 peripheral neuropathy (PN) at entry.</font></font></font></font></font></p>\n<p>\n <font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\">6. Breastfeeding.</font></font></font></font></font></font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\">7. Receipt of ART for more than 28 days immediately prior to entry. ART is allowed within the </font><font face=\"TimesNewRomanPSMT\">28-day window prior to study entry.</font></font></font></font></font></font></p>\n<p>\n <font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\">8. Prior or current systemic or locally administered chemotherapy.</font></font></font></font></font></font></font></p>\n<p>\n <font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\">9. Prior or current radiation therapy.</font></font></font></font></font></font></font></font></p>\n<p>\n <font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\">10. Prior or current immunotherapy, e.g., interferon alfa.</font></font></font></font></font></font></font></font></font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\">11. Corticosteroid use at doses above those given as replacement therapy for adrenal </font><font face=\"TimesNewRomanPSMT\">insufficiency within the last 30 days prior to study entry. A tapering course of corticosteroids </font><font face=\"TimesNewRomanPSMT\">as acute therapy for </font><i><font face=\"TimesNewRomanPS-ItalicMT\">Pneumocystis carinii </font></i><font face=\"TimesNewRomanPSMT\">pneumonia (PCP) or other conditions is an </font><font face=\"TimesNewRomanPSMT\">exception and is allowed.</font></font></font></font></font></font></font></font></font></font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\">12. Any immunomodulator, HIV vaccine, live attenuated vaccines, or other investigational </font><font face=\"TimesNewRomanPSMT\">therapy or investigational vaccine within 30 days prior to study entry.</font></font></font></font></font></font></font></font></font></font></font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\">13. Known allergy/sensitivity or any hypersensitivity to components of study drugs or their </font><font face=\"TimesNewRomanPSMT\">formulation.</font></font></font></font></font></font></font></font></font></font></font></font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\">14. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would </font><font face=\"TimesNewRomanPSMT\">interfere with adherence to study requirements</font></font></font></font></font></font></font></font></font></font></font></font></font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"><font face=\"TimesNewRomanPSMT\"> </font></font></font></font></font></font></font></font></font></font></font></font></p>\n<p>\n  </p>\n
      • primary_end_points<p>\n <span new=\"\" style=\"color: black; font-family: ;\" times=\"\"><strong>Progression-free survival</strong></span> <strong>defined as a</strong> lack of KS progression, death, entry into an additional step, or loss to follow-up<strong>, prior to week 48</strong>. </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence1
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic1
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Please refer to the Site Specific Addendum page (V) and appendix II page 106.</p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n <b><font face=\"DejaVuSans-Bold\" size=\"1\"><font face=\"DejaVuSans-Bold\" size=\"1\">KEMRI ERC. Approval letter dated 17 June 2013</font></font></b></p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration5 years
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPTX plus ART
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states9
      • number_of_sites2
      • multi_country_listKenya, USA, South Africa, Uganda, Botswana, Malawi, Brazil, Peru and Zimbabwe
      • data_monitoring_committeeYes
      • total_enrolment_per_site40-60
      • total_participants_worldwide706
      • 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_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameN/A
      • investigator1_middle_name
      • investigator1_family_nameN/A
      • investigator1_qualificationN/A
      • investigator1_professional_addressN/A
      • investigator1_telephoneN/A
      • investigator1_emailfkkirui@wrp-kch.org
      • organisations_transferred_Yes
      • number_participants100-120
      • notification
      • approval_date07-08-2012
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted03-07-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason.
      • approved2
      • approved_reason
      • final_report<p>\n This was an open-label, non-inferiority trial, that enrolled people with HIV and advanced stage AIDS-associated Kaposi sarcoma attending 11 AIDS Clinical Trials Group sites in Brazil, Kenya, Malawi, South Africa, Uganda, and Zimbabwe. Eligible participants were randomly assigned (1:1:1) with a centralized computer system to receive either intravenous bleomycin and vincristine or oral etoposide (the investigational arms), or intravenous paclitaxel (the control arm), together with antiretroviral therapy (ART; combined efavirenz, tenofovir disoproxil fumarate, and emtricitabine). <strong>The primary outcome was progression-free survival (PFS) at week 48, using a 15% non-inferiority margin to compare the investigational groups against the active control group. Safety was assessed in all eligible treated study participants. </strong>Non-inferiority of either investigational intervention was not shown, with paclitaxel plus ART showing superiority to both oral etoposide plus ART and bleomycin and vincristine plus ART, supporting its use in treating advanced AIDS-associated Kaposi sarcoma in resource-limited settings. 334 participants were enrolled between Oct 1, 2013, and March 8, 2018, when the study was closed early due to inferiority of the bleomycin and vincristine plus ART arm, as per the recommendations of the Data and Safety Monitoring Board (DSMB).</p>\n<p>\n The etoposide plus ART arm also closed due to inferiority in March, 2016, following a DSMB recommendation. Week-48 PFS rates were higher in the paclitaxel plus ART arm than in both investigational arms. The absolute differences in PFS were –30% (95% CI –52 to –8) for the comparison of paclitaxel plus ART (week 48 PFS 50%, 32 to 67; n=59) and etoposide plus ART (20%, 6 to 33; n=59), and –20% (–33% to –7%) for the comparison of paclitaxel plus ART (64%, 55 to 73; n=138) and bleomycin and vincristine plus ART (44%, 35 to 53; n=132). Both CIs overlapped the non-inferiority margin. The most common adverse events, in 329 eligible participants who began treatment, were neutropenia (48 [15%]), low serum albumin (33 [10%]), weight loss (29 [9%]), and anaemia (28 [9%]), occurring at similar frequency across treatment arms.</p>\n
      • implication_results<p>\n Yes, from the Publication:</p>\n<p>\n Ø  The Study’s results provide support for preferring paclitaxel over a commonly used regimen of bleomycin and vincristine or an oral etoposide regimen as first-line chemotherapy for advanced AIDS-related Kaposi sarcoma in resource-limited settings.</p>\n<p>\n Making paclitaxel widely available as the initial treatment for advanced AIDS-related Kaposi sarcoma in these settings will require enhancements to the infrastructure and personnel dedicated to cancer care. Analysis of the cost-effectiveness of different Kaposi sarcoma treatments would further inform national strategies.</p>\n
      • quantity_importedFind attached product accountability documents
      • quantity_dispensedFind attached product accountability documents
      • quantity_destroyedFind attached product accountability documents
      • quantity_exportedFind attached product accountability documents
      • balance_siteFind attached product accountability documents
      • final_date0000-00-00
      • modified2024-05-17 06:45:39
      • created2013-07-25 09:02:41
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id124
        • application_id195
        • given_nameJosphat
        • middle_name
        • family_nameKosgei
        • qualificationMBChB, MSc
        • professional_addressP.O. Box 1357 - 20200, Kericho Kenya
        • telephone+254 729 110 122
        • emailjosphat.kosgei@usamru-k.org
        • created2013-07-25 11:55:45
        • modified2020-07-03 08:21:26
    • SiteDetail(array)
      • 0(array)
        • id154
        • application_id195
        • county_id35
        • site_nameWRP/KEMRI - Kericho
        • physical_addressCRC, off Hospital Road, Kericho Kenya
        • contact_detailsP.O Box 1357, 20200, Kericho, Kenya
        • contact_personFredrick Kirui
        • site_capacity(null)
        • misc(null)
        • created2013-07-25 11:55:45
        • modified2020-07-03 08:21:26
        • County(array)
          • id35
          • county_nameKericho
          • created2012-06-15 10:26:16
          • modified2012-06-15 10:26:16
      • 1(array)
        • id155
        • application_id195
        • county_id27
        • site_nameAMPATH - MOI University Teaching Hospital Eldoret CRS
        • physical_addressDepartment of Internal Medicine, lst floor, MTRH Building, Nandi Road Eldoret
        • contact_details254-53 2060850
        • contact_personPriscilla Cheruiyot
        • site_capacity(null)
        • misc(null)
        • created2013-07-25 16:37:26
        • modified2020-07-03 08:21:26
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
    • Sponsor(array)
      • 0(array)
        • id100
        • application_id195
        • sponsorThe National Institute of Allergy and Infectious Diseases (NIAID), National Cancer Institute (NCI) and The NationalInstitute of Dental and Craniofacial Research (NIDCR).
        • sponsor_typeOthers
        • contact_person
        • addressHIV Research Branch TRP, DAIDS, NIAID, NIH 6700B Rockledge Drive Bethesda, MD 20892
        • telephone_number+1-301- 451-2761
        • fax_number
        • cell_number+1-301- 451-2761
        • email_addressactg.user.support@fstrf.org
        • created2013-07-25 11:55:45
        • modified2020-07-03 08:21:26
  • 1(array)
    • Application(array)
      • id177
      • user_id63
      • trial_status_id8
      • abstract_of_study<p style=\"margin-left:.5in;\">\n <strong>Protocol Synopsis</strong></p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:.5in;\">\n While developmental pharmacokinetic (PK) and pharmacodynamic (PD) studies are routinely performed for new drugs, there are few clinical PK and PD studies of currently licensed tuberculosis (TB) drugs.  Notably, detailed knowledge of PK/PD relationships can markedly accelerate drug development for antimicrobial agents.  For example, because of information on the PD of antiretroviral drugs and the availability of a convenient surrogate endpoint, Phase 2 trials of new protease inhibitors can be performed using as few as 20 patients per arm.  Thus a better understanding of PD relationships of antimycobacterial drugs could accelerate the difficult task of going from many possible combinations of drugs, doses, and drug combinations to the few that can be evaluated in large Phase 3 studies.</p>\n<p style=\"margin-left:.5in;\">\n Standard PK studies often include multiple sampling time points over 24 (or more) hours to determine AUC and peak concentration.  However, such dose-ranging studies of PK are intensive and unsuitable for critically ill patients who are much more likely to have highly abnormal PK that may be associated with differences in treatment outcome.  The analytic technique of population PK modeling is well-suited to the study of the PK and PD of TB drugs.  In population PK, models are fitted to all available data simultaneously instead of fitting models to each individual’s data.  This makes the population approach useful for sparse data sets, for which it is impossible to use the more traditional analytical approaches.  Also, population PK modeling is a powerful tool for studying the effects of key covariates on PK like HIV infection, degree of immunodeficiency, or the presence of liver disease.  The cohort of patients in TBTC Study 29X will be studied by either single specimen sampling per the parent Study 29X protocol or sparse sampling (3 samples) or intensive sampling (7 samples) as described in this sub-study protocol to support the construction of a rifapentine population PK model.  This 29X PK sub-study with intensive sampling of up to 80 patients (48 to 60 patients with rifapentine treatment and 20 controls with rifampin) will provide initial estimates for the iterative 2-stage Bayesian (IT2B) parametric analysis of the population PK model. We anticipate that approximately 70 patients will enroll for sparse sampling and  up to 110 additional patients will provide just a single PK sample in the parent Study 29X protocol.  Thus, the population PK model will include data regarding rifapentine in up to 240 patients. </p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p style=\"margin-left:.5in;\">\n The primary objective of this study is to characterize rifapentine and 25-desacetyl rifapentine pharmacokinetic parameters (AUC_0-24 and peak concentration) in patients with TB treated with 10, 15 or 20 mg/kg rifapentine daily.</p>\n
      • study_title<p>\n <strong>Pharmacokinetic and pharmacodynamic studies of efficacy, tolerability and safety of higher dosage rifapentine for treatment of tuberculosis</strong></p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/13/07/03
      • version_noV081811
      • date_of_protocol18-08-2011
      • study_drugNone (Rifapentine is being administered in the main study)
      • disease_conditionTuberculosis
      • 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_nameRifapentifne for the main study protocol (ECCT/11/08/05)
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressLMatata@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_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr Lena Matata
      • declaration_date120-07-2013
      • declaration_principal_investigatorNot Applicable
      • declaration_date220-07-2013
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<ul>\n <li>\n Any patient enrolled in TBTC Study 29X.</li>\n <li>\n Provision of informed consent for the study.</li>\n <li>\n Willingness to be sampled in an out-patient clinic or be admitted to a Clinical Research Center (CRC) or hospital on one occasion.</li>\n</ul>\n
      • principal_exclusion_criteria<ul>\n <li>\n  Severe anemia as defined by a hematocrit less than 25% (most recent value, measured within 30 days before the PK study sampling).</li>\n</ul>\n
      • primary_end_points<p>\n N/A</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyA pharmacokinetic and Pharmacodynamic Sub study
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n STAFF IN THIS STUDY: 2 MEDICAL DOCTORS, 1 PHARMACIST, 1 FULL-TIME NURSE, 1 PART TIME NURSE, 1 CO-ORDINATOR, 1 COMMUNITY MOBILISATION OFFICER, 1 QA MANAGER, OFFICERS, 1 QC OFFICER, 1 DATA MANAGER, 1 DATA OFFICER, 1 DATA SPECIALIST.</p>\n<p>\n SITE FACILITIES: CLINICAL TRIALS PHARMACY, BIO-SAFETY LEVEL 2 AND 3 TB LABORATORIES, LABORATORY FOR SAFETY PROFILE, ARRANGEMENT FOR IN AND OUT-PATIENT FACILITIES AT NEW NYANZA PROVINCIAL GENERAL HOSPITAL</p>\n<p>\n <u><strong>Profiles of key staff in TB Branch at KEMRI/CDC:</strong></u></p>\n<p>\n <u>Dr. Kevin Cain</u></p>\n<p>\n <strong><u>Position: TB branch Chief</u></strong></p>\n<p>\n Dr. Cain is the chief of the TB branch for KEMRI/CDC. Dr. Cain received his MD degree from the University of Pennsylvania School of Medicine in 2001. He then completed a 3 year residency training in internal medicine, is board certified in internal medicine, and is licensed in the state of Michigan. After completing internal medicine training in 2004, Dr. Cain joined CDC in Atlanta, where he completed 2 years of applied epidemiology training as an Epidemic Intelligence Service (EIS) officer with the International Research and Programs Branch of the Division of Tuberculosis Elimination. After completing EIS in 2006, he remained at CDC in the same branch. He became team lead for TB/HIV in 2008, and he was acting chief of the branch in late 2010 and early 2011 before accepting a position with CDC Kenya as the Chief of the TB Branch for KEMRI/CDC in Kisumu.</p>\n<p>\n Dr. Cain has led a variety of epidemiologic studies during his time at CDC, including studies of TB among foreign-born persons in the United States and of TB screening and diagnosis in people with HIV. Dr. Cain has over 20 publications in peer-reviewed literature, including first-author publications in the New England Journal of Medicine and the Journal of the American Medical Association. He also has authored several editorial commentaries at the invitation of scientific journals, has given multiple presentations at international conferences, and has worked closely with World Health Organization on global and regional policy. He led the development of a revised framework for TB/HIV for WHO in the Western Pacific Region. Currently, he is the US representative to the technical advisory group for TB for WHO Western Pacific Region.</p>\n<p>\n <u>Dr. Videlis Nduba</u></p>\n<p>\n <strong>Principal Investigator, Aeras 402 (NOCHAK) TB vaccine Trial, Adolescent and Infant TB cohort studies</strong></p>\n<p>\n Dr. Nduba is a principal investigator in the TB Research Branch, KEMRI/CDC where he leads the TB vaccine research section. He completed his medical degree at the University of Nairobi and proceeded to do a masters degree in public health at the university of Washington, Seattle, USA. He is currently enrolled as a PhD student at the University of Amsterdam, The Netherlands.</p>\n<p>\n Dr. Nduba previously worked in various research programs at KEMRI including acute bronchitis, pneumonia and HIV where he took various roles as a study doctor and a study coordinator. For the last four years Dr. Nduba has been involved in development of TB research capacity at KEMRI/CDC. This included conducting TB incidence cohort studies in infants and adolescents, part of which included improving TB research infrastructure such as TB laboratory upgrades funded by the European and Developing Countries Clinical Trials Partnership (EDCTP) and the Aeras Global TB Vaccine Foundation. Dr. Nduba has attended numerous courses as part of the capacity development process including, Good Clinical Practice (GCP), Ethical conduct of clinical trials, Project management and is a certified B grade reader for Chest X-rays using the Chest Radiograph and Recording system for interpreting chest x-rays in TB prevalence surveys.</p>\n<p>\n He is currently the principal investigator for a multisite Phase IIB TB vaccine trial sponsored by the Aeras Global TB vaccine foundation. He has made numerous scientific presentations in international conferences and is a co author on several articles published in peer reviewed journals.</p>\n<p>\n <u>Dr. Lena Matata</u></p>\n<p>\n <strong><u>Position: Principal Investigator, Tuberculosis Trials Consortium (TBTC) study</u></strong></p>\n<p>\n She holds the position of Principal Investigator for the Tuberculosis Trials Consortium (TBTC) drug trial. This is a multi-center clinical trial sponsored by CDC, Atlanta. It will evaluate a new TB treatment regimen that contains an experimental TB drug Rifapentine.</p>\n<p>\n She has worked previously in 3 government health facilities in Kenya in different capacities: medical doctor, research doctor and project manager. This includes working as a medical doctor, in the care of patients with HIV/AIDS and tuberculosis, most recently under the supervision of infectious disease specialist and the founder of Liverpool VCT Centre in Kenya, Dr. Miriam Taegtmeyer.</p>\n<p>\n Her initial experience in research was at the Kenya Medical Research Institute, Center for Geographic Medical Research-Wellcome Trust (Kilifi, Kenya). This led to 3 years experience as a Research Medical Doctor and ‘Project Manager, with the KEMRI/Wellcome-Trust, pneumococcal epidemiology surveillance team. She led the first adult study at KEMRI/WT that investigated the incidence of invasive bacterial diseases in adult in-patients’ at the Kilifi District Hospital.</p>\n<p>\n She also gained international research experience while completing a Master’s dissertation towards the fulfillment of a degree in Masters’ of Science in Global Health at the University of Oxford (UK). The Masters ‘research project was carried out at the University of Colombo, Sri Lanka.</p>\n<p>\n <u>Lazarus Odeny</u></p>\n<p>\n <strong><u>Position: Senior Data Manager</u></strong></p>\n<p>\n He holds the position of TB branch Senior Data Manager</p>\n<p>\n He has over 10 years of data management, biostatistics and epidemiology experience. He is currently registered for a doctor of science in Epidemiology (PhD) at the Erasmus University in Rotterdam, Netherlands.</p>\n<p>\n He has held the following positions:</p>\n<p style=\"margin-left: 0.25in;\">\n 1. Senior Data Analyst and Data manager – <strong>KEMRI/CDC</strong></p>\n<p style=\"margin-left: 0.25in;\">\n 2. Senior Data manager – International Centre for Reproductive Health (<strong>ICRH</strong>)</p>\n<p style=\"margin-left: 0.25in;\">\n 3. Data manager – <strong>KEMRI/CDC</strong></p>\n<p>\n He is proficient in SAS, SPSS, EPIINFO, STATA, Microsoft office 2003 suite (Word, Excel, PowerPoint, Access), VFP, Visual CE for PDA, Microsoft visual basic, DOTNET framework, S-Plus, C + +, SQL, ISA firewall server administrator and SQL servers. All large studies conducted by the TB branch in the past several years have utilized electronic data collection and management, and this process has been designed and managed by Lazarus.</p>\n<p>\n <u>Dr. Victor Mudhune</u></p>\n<p>\n <strong><u>Position: Clinical Trials Pharmacist</u></strong></p>\n<p>\n He holds the position of study pharmacist in the HIV research and TB branches and is the pharmacist for the TBTC drug trial. He previously worked as a hospital pharmacist.</p>\n<p>\n His major duties as a clinical trials pharmacist include:</p>\n<p style=\"margin-left: 0.25in;\">\n 1. Coordination of all issues related to study drug/placebo supply and preparing all doses for administration and dispensing by the nurses.</p>\n<p style=\"margin-left: 0.25in;\">\n 2. Maintaining appropriate records of the receipt and disposition of the study vaccine, placebos, benefit vaccine and inventory of all medicines.</p>\n<p style=\"margin-left: 0.25in;\">\n 3. Monitoring and documenting cold chain maintenance for all study vaccines to ensure quality of the products is not compromised.</p>\n<p style=\"margin-left: 0.25in;\">\n 4. Managing study participant randomization process and preparing the study vaccine/placebo doses for administration to study participants as per the study vaccine management manual.</p>\n<p style=\"margin-left: 0.25in;\">\n 5. Maintaining the blinding of the participant’s treatment assignment to investigators, study nurses, clinic staff and participant.</p>\n<p style=\"margin-left: 0.25in;\">\n 6. Maintaining the confidentiality of the participant, participant’s pharmacy file and the study drug/placebo accountability record.</p>\n<p style=\"margin-left: 0.25in;\">\n 7. Establishing a system to ensure that the participants sign an informed consent before dispensing the drugs and ensuring that the current IRB approved version of the protocol is adhered to in dispensing the drug/placebo.</p>\n<p style=\"margin-left: 0.25in;\">\n 8. Ensuring the security of all documents and investigational drug/placebo.</p>\n<p style=\"margin-left: 0.25in;\">\n 9. Preparing pharmacy related standard operating procedures ensuring they meet GCP, NIH and other regulatory requirements.</p>\n<p style=\"margin-left: 0.25in;\">\n 10. Following established departmental policies, procedures and objectives, continuous quality improvement objectives and safety, environmental and/or infection control standards.</p>\n<p style=\"margin-left: 0.25in;\">\n 11. Providing overall supervision to senior TB branch staff on pharmacy related activities.</p>\n<p>\n He has worked as a research pharmacist for the last 4.5 years as a research pharmacist and is trained in GCP, Human Subject Protection, NIH online training, and clinical trial management. He is currently training others in the same courses at the KEMRI/CDC field stations.</p>\n<p>\n He has been involved in site preparations for the PAVE 100 trial, a DAIDS sponsored trial and in a completed study (the Kisumu Breastfeeding Study). He also functioned as backup pharmacist in a completed vaccine study (Rotavirus Vaccine Study).</p>\n<p>\n He is the clinical trial pharmacist for the HPTN 052, a DAIDS sponsored trial, and the pharmacist to: Aeras 402 vaccine trial (TB vaccine study), the TBTC drug trial and GSK MAL055/058 Vaccine trial.</p>\n<p>\n <u>Albert Ochieng Okumu</u></p>\n<p>\n <strong><u>Position: Laboratory Manager </u></strong></p>\n<p>\n He holds the position of Laboratory Manager for the KEMRI/CDC, TB laboratory at the Kisian field station. His focus is on the quality and excellent performance of the KEMRI/CDC TB research laboratory. He has been able to receive into this laboratory study monitors, lab assessment visitors and auditors conducting assessments of the TB clinical trials at the site.</p>\n<p>\n He has received and also coordinated trainings in: Good Clinical Laboratory Practice, participation in external quality assessment programmes and developed in house Quality Control systems.</p>\n<p>\n He has worked previously with government health facilities in Kenya in different capacities, such as a laboratory technologist, government health facility laboratory in-charge and government laboratories district in-charge. His work with the Ministry of Health gave him experience in routine laboratory tests and procedures, laboratory diagnostics including in patients with TB and HIV of all ages.</p>\n<p>\n His initial research experience was at the Kenya Medical Research Institute, Centre for Microbiology Research, Kisumu, in an ‘Investigational New Drug’ HIV trial sponsored by the Gates foundation. This study was conducted for five years and it was implemented by Partners in Prevention (University of Washington). In his role in the study he was able to establish a functional clinical research laboratory. He also supported various sub- studies that conducted several laboratory assays for participants in microbicide studies such as: Female ViVaGel-USA, IPM (International partnerships for microbicides) of South Africa.</p>\n<p>\n He has received trainings and skills in Good Clinical Laboratory Practice (GCLP) and Ethics (IAVI and Vienna School of Clinical Research), International shipping regulations (IATA, Mayo) and he has coordinated trainings in: GCLP, participation in external quality assessment programs and developed in-house Quality Control systems.</p>\n<p>\n <u>Janet Agaya</u></p>\n<p>\n <strong><u>Position: Study Coordinator Tuberculosis Trials Consortium (TBTC) study</u></strong></p>\n<p>\n She holds the position of study coordinator in the Tuberculosis Trials Consortium (TBTC) study</p>\n<p>\n She is has worked previously as a Public Health officer at the Ministry of Health, Kenya and holds a Masters degree in Public Health. She has participated in many research projects in different capacities with products in reports, published and unpublished papers.</p>\n<p>\n She has successfully coordinated TB studies in KEMRI/CDC including TB prevalence surveys from 2005 to date. This has involved management of field activities for several TB research studies and working with people from different communities and cultural backgrounds.</p>\n<p>\n She has received training that is relevant to her work in research and this includes: Good Clinical Practice, Scientific Writing, Epidemiology, Research Ethics, Health Behavior and Education for Community Health Workers.</p>\n<p>\n <u>Benard Owuor</u></p>\n<p>\n <strong><u>Position: TB branch Administrative Manager</u></strong></p>\n<p align=\"left\">\n He holds the position of TB branch Administrative Manager. His qualifications include: MBA (finance), BBA (Accounting), CPA and Diploma in information technology and computer sciences.</p>\n<p align=\"left\">\n His work experience in accounting, auditing and management covers 10 years at KEMRI/CDC and at 2 educational institutions. He also has 6 years experience as an administrator where he has been able to demonstrate: good leadership, organisational management, team-building skills, flexibility and strong communication skills.</p>\n<p>\n In his capacity as administrative manager in the TB research branch, KEMRI/CDC he has been able to oversee financial management, organisational management and administrative tasks for several TB branch research studies, managing budgets of millions of dollars, and handling all reporting and auditing requirements for sponsors.</p>\n
      • other_details_explanation<p>\n The trial was conducted in the host country and in 8 other countries including Kenya</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n Will be confirmed and communicated</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_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI-CDC
      • single_site_physical_addressKEMRI-CDC Field station. Off- Kisumu-Busia Road
      • single_site_contact_personDr Lena Matata
      • single_site_telephone+254700111398
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states9
      • number_of_sites
      • multi_country_listUSA, BRAZIL, SPAIN, PERU, HONG KONG, VIETNAM, SOUTH AFRICA, UGANDA, KENYA
      • data_monitoring_committeeYes
      • total_enrolment_per_site18
      • total_participants_worldwide320
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_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_nameDr Elisha
      • investigator1_middle_name
      • investigator1_family_nameOkeyo
      • investigator1_qualificationMBCHB
      • investigator1_professional_addressPO BOX 1758-40100, Kisumu, Kenya
      • investigator1_telephone+254721410654
      • investigator1_emailEokeyo@kemricdc.org
      • organisations_transferred_Yes
      • number_participants18
      • notification<p>\n None</p>\n
      • approval_date07-12-2011
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted20-07-2013
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2015-08-08 14:42:54
      • created2013-07-19 14:33:32
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id115
        • application_id177
        • given_nameDr Lena
        • middle_name
        • family_nameMatata
        • qualificationMBCHB
        • professional_addressPO BOX 1758-40100, Kisumu, Kenya
        • telephone+254700111398
        • emailLmatata@kemricdc.org
        • created2013-07-20 13:15:30
        • modified2013-07-20 14:57:28
    • SiteDetail(array)
      • 0(array)
        • id144
        • application_id177
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2013-07-20 13:15:30
        • modified2013-07-20 14:57:28
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id91
        • application_id177
        • sponsorDivision of Tuberculosis Elimination (Tuberculosis Trials Consortium)-CDC
        • sponsor_type(null)
        • contact_personDr. Stefan Goldberg
        • addressCenters for Disease Control and Prevention 1600 Clifton Rd Atlanta, GA 30333
        • telephone_number404.639.8239
        • fax_number404.639.8961
        • cell_number+14046395339
        • email_addressssg3@cdc.gov
        • created2013-07-20 13:15:30
        • modified2013-07-20 14:57:28
  • 2(array)
    • Application(array)
      • id133
      • user_id40
      • trial_status_id5
      • abstract_of_study<p>\n <strong>Background: </strong>The development of an effective, accessible vaccine is the only realistic hope for halting the human immunodeficiency virus type 1 epidemic. Ideally, such a vaccine should induce broadly neutralizing antibodies and effective T cells at the same time; however, both of these goals face substantial and very different challenges. A rational scientific strategy tackles and solves these roadblocks separately before combining the two successful solutions into a single vaccine formulation. This study focuses on induction of effective T cells.</p>\n<p>\n <strong>Method:</strong> We propose to conduct a Phase 1/IIa randomized, placebo-controlled, double-blind clinical trial in HIV-uninfected healthy adult volunteers at low-risk for HIV infection to evaluate the safety, tolerability and immunogenicity of the three vaccines pSG2.HIVconsv DNA (D), ChAdV63.HIVconsv (C) and MVA.HIVconsv (M) in Kenya using CM and DDDCM regimens.</p>\n<p>\n <strong>Primary Objectives</strong></p>\n<ul>\n <li>\n To evaluate the safety of the pSG2.HIVconsv DNA, ChAdV63.HIVconsv and MVA.HIVconsv vaccines administered sequentially by intramuscular needle injection in heterologous prime-boost regimens into healthy, low-risk, HIV-1-uninfected adult volunteers.</li>\n</ul>\n<p>\n <strong>Secondary Objectives</strong></p>\n<ul>\n <li>\n To evaluate the immunogenicity of the pSG2.HIVconsv DNA, ChAdV63.HIVconsv and MVA.HIVconsv vaccines administered sequentially by intramuscular needle injection in two different heterologous prime-boost regimens into healthy, low-risk, HIV-1-uninfected adult volunteers.</li>\n <li>\n To compare the immunogenicity (breadth, specificity and HIV-1 clade coverage of T cell responses) of two regimens DDDCM and CM.</li>\n <li>\n To determine whether priming with three DNA vaccinations (DDDCM regimen) affects the frequency, durability and/or quality of T cell responses to the HIVconsv immunogen by comparing responses to the DDDCM and CM regimens.</li>\n</ul>\n<p>\n  </p>\n<p>\n <strong>Study Population:</strong> The study population consists of healthy male or female adults aged 18-50 years at low risk for HIV infection, who are willing to undergo HIV testing, use an effective method of contraception, and who in the opinion of the investigator or designee, understand the study and provide written informed consent. Approximately 48 volunteers (40 vaccine recipients, 8 placebo recipients) who meet all eligibility criteria will be included in the study.</p>\n
      • study_title<p>\n A phase I/IIa clinical trial of universal HIV-1 vaccines pSG2.HIVconsv DNA, MVA.HIVconsv and ChAdV63.HIVconsv in combined regimens in healthy HIV-1/2-negative adults in Nairobi.</p>\n
      • laymans_summary(null)
      • short_titleHIVCORE004/N004
      • protocol_noECCT/13/07/01
      • version_no2.3
      • date_of_protocol15-04-2013
      • study_drugpSG2.HIVconsv DNA; non-replicating chimp adenovirus ChAdV63.HIVconsv; non-replicating poxvirus MVA.HIVconsv.
      • disease_conditionHIV vaccine development
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressgmutua@kaviuon.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr. Gaudensia Nzembi Mutua
      • declaration_date105-07-2013
      • declaration_principal_investigatorProf. Walter Jaoko
      • declaration_date205-07-2013
      • placebo_presentYes
      • study_objectives(null)
      • principal_inclusion_criteria<ol>\n <li>\n Healthy male or female, as assessed by a medical history, physical exam, and laboratory tests</li>\n <li>\n <p>\n At least 18 years of age on the day of screening and has not reached his/her 51st birthday on the day of first vaccination</p>\n </li>\n <li>\n <p>\n If sexually active female; using an effective method of contraception (e.g. hormonal contraception, diaphragm, intra-uterine device (IUD), condoms, anatomical sterility in self or partner) from 14 days prior to the first vaccination until at least 6 weeks after the last vaccination</p>\n </li>\n <li>\n <p>\n Assessed by the clinic staff as being at “low risk” for HIV infection on the basis of self-reported sexual behaviour within the 6 months prior to enrolment</p>\n </li>\n <li>\n <p>\n Willing to forgo donations of blood during the study.</p>\n </li>\n</ol>\n
      • principal_exclusion_criteria<ol>\n <li>\n Confirmed HIV-1 or HIV-2 infection</li>\n <li>\n Any clinically significant acute or chronic medical condition that is considered progressive, or in the opinion of the investigator, makes the volunteer unsuitable for participation in the study</li>\n <li>\n If female, pregnant or planning a pregnancy within 6weeks after the last study vaccination; or lactating</li>\n <li>\n Smallpox vaccination within the previous 3 years (smallpox vaccination more than 3 years before enrolment should be documented but is not an exclusion criterion).</li>\n</ol>\n
      • primary_end_points<p>\n The safety of the vaccines will be determined by analysis of local and systemic reactogenicity, and biochemical and haematological data.</p>\n<p>\n The data will be expressed as</p>\n<p>\n •           Proportion of volunteers who develop a grade 3 or 4 local reaction.</p>\n<p>\n •           Proportion of volunteers who develop a grade 3 or 4 systemic reaction.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyImmunogenicity
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n The study will be conducted at the KAVI-Kangemi site which is community based in a slum area within the environs of Nairobi and is located within the premises of a government sponsored Kangemi health centre. Accessibility is good by public transport and it is a 30-45min drive away from the main KAVI-KNH site. KAVI-KNH site is located off Ngong road within the premises of the Kenyatta National Referral hospital and covers two floors in the department of Medical Microbiology of the University of Nairobi. The site facilities are largely comprised of re-furbished shipping containers. It has a pharmacy that is under 24hour automated temperature control and is supported by a 27KVA generator. It has a small laboratory for sample collection and initial sample processing but the main laboratory is located in the KAVI-KNH study site. The site has emergency facilities with a portable defibrillator to manage any acute medical conditions that may arise during the conduct of the clinical trial. KAVI-KNH forms the administrative centre for the two sites. Each site holds weekly meetings to discuss ongoing studies and both sites hold a joint meeting at KAVI-KNH every two weeks. The key staff are listed below:</p>\n<p>\n <strong>Prof. Walter Jaoko;  MBCHB PHD</strong></p>\n<p>\n Principal Investigator</p>\n<p>\n Department of Medical Microbiology -University of Nairobi</p>\n<p>\n PO Box 19676 Nairobi, Kenya</p>\n<p>\n Tel: +254 727555254</p>\n<p>\n Fax: +254 (0) 022714613</p>\n<p>\n Email: <span style=\"text-decoration: underline;\">wjaoko@kaviuon.org</span></p>\n<p>\n  </p>\n<p>\n <strong>Gaudensia Mutua MBChB, MPH</strong></p>\n<p>\n Sub-Investigator</p>\n<p>\n Department of Med. Microbiology (UON)</p>\n<p>\n Tel: +254733826815</p>\n<p>\n Email: <a href=\"mailto:gmutua@kaviuon.org\">gmutua@kaviuon.org</a></p>\n<p>\n <strong>Kefa Ogonyo Bosire (B.Pharm, M.Pharm(UoN), MSc (London)</strong></p>\n<p>\n Consultant Pharmacist</p>\n<p>\n Dept. Pharmacology (School of Pharmacy)</p>\n<p>\n University of Nairobi</p>\n<p>\n Tel: +254733241332 or +254713542111</p>\n<p>\n                                    </p>\n<p>\n <strong>Jacqueline Rita Nyange KRN, BA, MSc.    </strong></p>\n<p>\n Clinical Trials Coordinator/Regulatory Compliance Officer</p>\n<p>\n Dept. Med. Microbiology- UON</p>\n<p>\n Tel: +254722899532</p>\n<p>\n Email: <a href=\"mailto:jrnyange@kaviuon.org\">jrnyange@kaviuon.org</a></p>\n<p>\n  </p>\n<p>\n <strong>Rose Sajabi KRN/M/PH, BSc Psychology</strong></p>\n<p>\n Study Coordinator/Nurse Counsellor</p>\n<p>\n Dept Med. Microbiology- UON</p>\n<p>\n Tel: +254722259866</p>\n<p>\n Email: <a href=\"mailto:rsajabi@kaviuon.org\">rsajabi@kaviuon.org</a></p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <strong>Bashir Farah MSc</strong></p>\n<p>\n Laboratory Manager</p>\n<p>\n Dept. Med. Microbiology- UON</p>\n<p>\n Tel: +254722566945</p>\n<p>\n Email: <a href=\"mailto:fbashir@kaviuon.org\">fbashir@kaviuon.org</a></p>\n
      • other_details_explanation<p>\n The study products in this study have been used in other studies in the host country (UK)</p>\n
      • other_details_regulatory_notapproved<p>\n Not applicable</p>\n
      • other_details_regulatory_approved<p>\n Not applicable</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_durationVolunteers will be screened up to 28 days before the 1st vaccination. This study will last 19 months (from screening of first volunteer to 5 months after last immunisation of last volunteer, assuming approximately 2 recruits per week)
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo reciepients will
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKAVI-KANGEMI RESEARCH SITE
      • single_site_physical_addressKANGEMI HEALTH CENTRE
      • single_site_contact_personDR GAUDENSIA MUTUA
      • single_site_telephone+254733826815
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site48 (Only one site involved in this study)
      • total_participants_worldwide48
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameNot Applicable
      • investigator1_middle_name
      • investigator1_family_nameNA
      • investigator1_qualificationNA
      • investigator1_professional_addressNA
      • investigator1_telephoneNA
      • investigator1_emailwjaoko@kaviuon.org
      • organisations_transferred_Yes
      • number_participants48
      • notification
      • approval_date19-06-2013
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted05-07-2013
      • 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)
      • modified2016-03-03 13:02:40
      • created2013-05-21 15:06:07
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id82
        • application_id133
        • given_nameProf. Walter
        • middle_nameGodfrey
        • family_nameJaoko
        • qualificationMBChB PhD
        • professional_addressKAVI- Institute of Clinical Research, University of Nairobi PO Box 19676-00202 Nairobi Kenya
        • telephone+254 727555254
        • emailwjaoko@kaviuon.org
        • created2013-05-21 15:15:31
        • modified2013-07-05 13:19:16
    • SiteDetail(array)
      • 0(array)
        • id102
        • application_id133
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2013-05-21 15:15:31
        • modified2013-07-05 13:19:16
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id63
        • application_id133
        • sponsorUniversity of Oxford
        • sponsor_type(null)
        • contact_personProfessor Tomáš Hanke
        • addressUniversity of Oxford, Joint Research Office, Block 60, Churchill Hospital, Oxford OX3 7LE UK
        • telephone_number+44 (0)1865 617630
        • fax_number+44 (0)1865 630608
        • cell_number+44 (0)1865 617630
        • email_addresstomas.hanke@ndm.ox.ac.uk
        • created2013-05-21 15:15:31
        • modified2013-07-05 13:19:16
  • 3(array)
    • Application(array)
      • id136
      • user_id74
      • trial_status_id(null)
      • abstract_of_study<p>\n <strong>Background:</strong> Clindamycin plus quinine is recommended by World Health Organization as a non-artemisinin-based antimalarial drug combination. The evidence on the efficacy of clindamycin plus quinine compared with other antimalarial drugs is scanty, outdated and inconclusive. No studies have compared the efficacy of clindamycin plus quinine with that of artemether-lumefantrine in the treatment of participants with uncomplicated falciparum malaria.</p>\n<p>\n <strong>Objective:</strong> To evaluate the therapeutic efficacy and safety of oral clindamycin plus quinine vs. artemether-lumefantrine in the treatment of uncomplicated falciparum malaria in children residing in an area of intense malaria transmission of western Kenya.</p>\n<p>\n <strong>Methods: </strong>An open-label randomised controlled clinical trial will be conducted at Ahero Sub-District Hospitals between September 2012 and June 2014. Study participants will be 384 children aged < 5 years with confirmed uncomplicated falciparum malaria. The participants will be randomised in a ratio of 1:1 to receive directly observed treatment with either clindamycin plus quinine or artemether-lumefantrine. Clinical and parasitological parameters will be monitored over 28 days follow up period to evaluate drug efficacy and safety.  The primary end-point will be the proportion of participants experiencing parasitological cure within 28 days of starting treatment. We will differentiate recrudescence from re-infections by analysis of MSP₁, MSP₂ and GLURP genes. Secondary end points will include fever resolution rates, parasite clearance rates, gametocyte carriage, change in mean haemoglobin (between day 0 and day 28), frequency of molecular markers of drug resistance and incidence of adverse events. This study will provide evidence that may be useful for informing the treatment policies for patients with uncomplicated <em>P. falciparum</em> malaria.</p>\n
      • study_title<p align=\"center\">\n An open-label randomized controlled trial of the efficacy and safety of Clindamycin plus quinine compared with artemether-lumefantrine for the treatment of children with uncomplicated  falciparum malaria in western Kenya</p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/13/05/02
      • version_no1.2
      • date_of_protocol05-10-2012
      • study_drugCLINDAMYCIN PLUS QUININE
      • disease_conditionMALARIA
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameClindamycin
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresscobonyo65@yahoo.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr Charles Owuora Obonyo
      • declaration_date129-05-2013
      • declaration_principal_investigatorDr Charles Owuora Obonyo
      • declaration_date229-05-2013
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n <strong>Inclusion criteria for enrolment:</strong></p>\n<ol>\n <li>\n Age 6-59 months</li>\n <li>\n Axillary temperature ≥ 37.5º C or history of fever in the past 48 hours</li>\n <li>\n Weight ≥ 5.0 kg</li>\n <li>\n Slide-confirmed infection with <em>P. falciparum</em></li>\n <li>\n Parasitaemia 2,000-200,000 asexual forms per <em>μl</em></li>\n <li>\n Parent/guardian provides informed consent</li>\n</ol>\n<p>\n  </p>\n<ul>\n <li>\n  </li>\n</ul>\n
      • principal_exclusion_criteria<p>\n <strong>Exclusion criteria for enrolment:</strong></p>\n<ol>\n <li>\n Presence of general danger signs or other signs of severe malaria and complicated falciparum malaria according to current WHO definitions [7]</li>\n <li>\n Mixed or mono-infection with another <em>Plasmodium </em>species</li>\n <li>\n Presence of severe malnutrition, defined as weight-for-age ≤ 3 standard deviations below the mean (NCHS/WHO normalized reference values)</li>\n <li>\n Known hypersensitivity to any of the drugs being tested</li>\n <li>\n Presence of febrile conditions caused by diseases other than malaria</li>\n <li>\n Presence of other serious or chronic medical conditions (heart failure, sickle cell disease).</li>\n <li>\n Plan to travel or leave the area within the next 1 month</li>\n <li>\n Inability to swallow oral medication</li>\n <li>\n Residence beyond 10km of the catchment area of the study hospital.</li>\n</ol>\n
      • primary_end_points<p>\n Proportion of children experiencing clinical and parasitological cure by day 28 after receiving study treatment</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <font face=\"Helvetica\">Dr Kevin Omondi Bachelor of Medicine and Bachelor of Surgery.3 years clinical trial </font><font face=\"Helvetica\">research experience. GCP/GCLP certified</font></p>\n<p>\n <font face=\"Helvetica\">Mr Julian KE Omondi Diploma in Clinical medicine. 3 years trial experience. GCP certified</font></p>\n<p>\n <font face=\"Helvetica\">Ms Nelly Koskei Diploma in Community Health Nursing. 3 years clinical trial research </font><font face=\"Helvetica\">experience. GCP/GCLP certified.</font></p>\n<p>\n <font face=\"Helvetica\">Mr Kevin Magare Diploma in Community Health Nursing. 2 years clinical trial research </font><font face=\"Helvetica\">experience. GCP certified.</font></p>\n<p>\n <font face=\"Helvetica\">Mr Wycliffe Misiayi Diploma in Community Health Nursing. 2 years clinical trial research </font><font face=\"Helvetica\">experience. GCP certified.</font></p>\n<p>\n <font face=\"Helvetica\">Grace Owino Diploma in Medical Laboratory Technology. 3 years clinical trial research </font><font face=\"Helvetica\">experience. GCP/GCLP certified.</font></p>\n<p>\n <font face=\"Helvetica\">Festus Okute Certificate in Medical Laboratory Technology. 15 years clinical trial research </font><font face=\"Helvetica\">experience. GCP/GCLP certified.</font></p>\n<p>\n <font face=\"Helvetica\">Erick Otiu Diploma in Computer and systems engineering. 2 years clinical trial  </font><font face=\"Helvetica\">research experience. GCP certified</font></p>\n
      • other_details_explanation<p>\n The study will be done in Kenya and is also sponsored by KEMRI, which is the Kenyan Medical Research Institute. </p>\n
      • other_details_regulatory_notapproved<p>\n NIL</p>\n
      • other_details_regulatory_approved<p>\n The KEMRI Ethics Committee reviewed the protocol of this study and approved it on 10th October 2012</p>\n
      • other_details_regulatory_rejected<p>\n NIL</p>\n
      • other_details_regulatory_halted<p>\n Not applicable, as the trial has not yet started.</p>\n
      • estimated_duration24 months
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorArtemether-lumefantrine
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaAhero Sub-district Hospital
      • single_site_physical_addressAlong Kericho to Kisumu Highway
      • single_site_contact_personDr Kevin Omondi
      • single_site_telephone+254 722740654
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site384
      • total_participants_worldwide384
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
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        • application_id136
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        • telephone+254 724993118
        • emailcobonyo65@yahoo.com
        • created2013-05-22 15:57:05
        • modified2013-06-03 13:59:00
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        • telephone_number+254 57 22924
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        • email_addressjvulule@kemri.org
        • created2013-05-22 15:57:05
        • modified2013-06-03 13:59:00
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      • id126
      • user_id72
      • trial_status_id5
      • abstract_of_study<p>\n  </p>\n<h2>\n Primary Objectives</h2>\n<p>\n The primary objective of this research study is:</p>\n<ul>\n <li>\n To evaluate the safety, efficacy and the course of wound healing when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents.</li>\n</ul>\n<p>\n  </p>\n<h2>\n Secondary Objectives</h2>\n<p>\n The secondary objectives of this research study are:</p>\n<ul>\n <li>\n To determine the acceptability of the Shang Ring device by the participants(or their parents)</li>\n</ul>\n<p>\n  </p>\n<ul>\n <li>\n To evaluate the ease of use of using the Shang Ring as a device for male circumcision across four age groups.</li>\n</ul>\n<h1>\n  </h1>\n<h2>\n Primary Endpoints</h2>\n<p>\n We will address the primary objectives by evaluating the following endpoints:</p>\n<ul>\n <li>\n To evaluate efficacy, procedural time and peri- and postoperative surgical complications associated with pediatric Shang Ring circumcision shall be assessed. To evaluate safety, we will clinically observe for adverse events during the course of healing. We will also evaluate the length of time required for complete healing.</li>\n</ul>\n<h2>\n Secondary Endpoints</h2>\n<p>\n We will address the secondary objectives by evaluating the following endpoints:</p>\n<ul>\n <li>\n To determine client acceptability, the clients (and/or parents) shall be interviewed on their experience with the Shang Ring during their participation in the study.</li>\n</ul>\n<p style=\"margin-left:.5in;\">\n  </p>\n<ul>\n <li>\n To evaluate the ease of use of the Shang Ring device, clinicians shall be interviewed on the difficulties they faced with using the device and their perception about use of the device relative to conventional surgical approaches, and answer a final questionnaire on their recommendation</li>\n</ul>\n
      • study_title<p>\n <strong>Use of the Shang Ring device in all four childhood age groups in the African population</strong></p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/13/05/01
      • version_no0.7
      • date_of_protocol05-02-2013
      • study_drugN/A
      • disease_conditionN/A
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_name
      • product_type_medical_device_nameShang Ring
      • comparator(null)
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      • ecct_not_applicable0
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      • email_addressqawori@engenderhealth.org
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      • declaration_applicantQuentin D Awori
      • declaration_date129-05-2013
      • declaration_principal_investigatorQuentin D Awori
      • declaration_date229-05-2013
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n  </p>\n<p>\n • Must be accompanied by the parent or legally acceptable representative (LAR), who freely consents  for participation of the child into the study;</p>\n<p>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Assent from participant 7 years of age and above who understand study procedure;</p>\n<p>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Aged between 1 month and 17 years(inclusive);</p>\n<p>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Body weight of more than 2.5 kgs and penile shaft more than 1 cm in length.</p>\n<p>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Must be in good general health;</p>\n<p>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Must be free of genital ulcerations or other visible signs of STI (on examination); </p>\n<p>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Parent or LAR and if possible the client must be able to understand study procedures and requirements of study participation;</p>\n<p>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Parent or LAR must agree to return the client to the study site for the full schedule of follow-up visits after his circumcision; </p>\n<p>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Parent or LAR must have a cell phone or access to a cell phone; and, </p>\n<p>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Parent or LAR must agree to provide the study staff with an address, phone number, or other locator information while participating in the research study</p>\n<p>\n  </p>\n<p>\n  </p>\n
      • principal_exclusion_criteria<p>\n  </p>\n<p>\n A client will be excluded from participation in this research study if he has any of the following exclusion criteria:</p>\n<ul>\n <li>\n Has a known allergy or sensitivity to lidocaine or other local anesthesia;</li>\n <li>\n Takes a medication that would be a contraindication for elective surgery, such as an anticoagulant or steroid;</li>\n <li>\n Has known bleeding/clotting disorder (e.g. hemophilia);</li>\n <li>\n Has  any congenital genitourinary abnormality;</li>\n <li>\n Has an active genital infection, anatomic abnormality or other condition (e.g. severe obesity, diabetes or sickle cell anemia), which in the opinion of the surgeon, prevents the man from undergoing a circumcision as part of this study; or</li>\n <li>\n Is currently participating in another biomedical research study. </li>\n</ul>\n
      • primary_end_points<p>\n  </p>\n<ul>\n <li>\n To evaluate efficacy, procedural time and peri- and postoperative surgical complications associated with pediatric Shang Ring circumcision shall be assessed. To evaluate safety, we will clinically observe for adverse events during the course of healing. We will also evaluate the length of time required for complete healing.</li>\n</ul>\n
      • scope_diagnosis0
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      • scope_safety1
      • scope_efficacy1
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      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
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      • trial_other1
      • trial_other_specifyMedical device in individuals below 18 years of age
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n <strong>Staff at site who will conduct the research</strong></p>\n<ul>\n <li>\n Hospital surgeon\n <ul>\n <li>\n Dr Raymond Simba (Co investigator)- MMED Surg</li>\n </ul>\n </li>\n <li>\n 2 murses - KRCHN\n <ul>\n <li>\n Jairus Oketch</li>\n <li>\n Alex Aduda</li>\n </ul>\n </li>\n <li>\n 1 Research Assistant\n <ul>\n <li>\n To be decided (Dan Ouma)Â </li>\n </ul>\n </li>\n <li>\n 1 Lead social mobiliser\n <ul>\n <li>\n to be decided (Nereah Obura/ Val Mumma)</li>\n </ul>\n </li>\n <li>\n Support staff (1)</li>\n</ul>\n<p>\n <strong>Site & Facility building</strong></p>\n<p style=\"margin-left: 40px;\">\n Homa bay distirct hospital - VMMC Theatre</p>\n
      • other_details_explanation<p>\n The host country of this study is Kenya.</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<ul>\n <li>\n <span style=\"font-size:16px;\">Weil Cornell Medical College IRB : Approval granted on 14 March 2013</span></li>\n</ul>\n<p>\n <span style=\"font-size:16px;\">​</span></p>\n<ul>\n <li>\n <span style=\"font-size:16px;\">KEMRI Ethical Review Committee - Approval Granted on 30April 2013</span></li>\n</ul>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_durationField time - 3 months, 2 months for analysis and manuscript write up
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaHoma Bay District Hospital
      • single_site_physical_addressHoma bay distirct hospital
      • single_site_contact_personDr. Raymond Otieno MMED(Surg)
      • single_site_telephone0723 886 261
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site80
      • total_participants_worldwide80
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentYes
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female0
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameQuentin
      • investigator1_middle_nameDavid
      • investigator1_family_nameAwori
      • investigator1_qualificationMBChB (UoN), Certified Phyisicain Investigar (ACRP), MPH (continuing)
      • investigator1_professional_addressABC Place, Westlands. Waiyaki Way
      • investigator1_telephone0722 913 616
      • investigator1_emailQAwori@engenderhealth.org
      • organisations_transferred_Yes
      • number_participants80
      • notification
      • approval_date18-04-2013
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted29-05-2013
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
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      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<div>\n <strong>Introduction</strong>: Male circumcision is a proven prevention strategy against the spread of HIV. The World Health Organization’s</div>\n<div>\n new 2016–2021 strategic framework on voluntary medical male circumcision (VMMC) targets 90% of males aged 10–29 years</div>\n<div>\n to receive circumcision by 2021 in 14 priority sub-Saharan countries while anticipating an increase in the demand for infant</div>\n<div>\n circumcision. It also states that the use of circumcision devices is a safe and efficient innovation to accelerate attainment of</div>\n<div>\n these goals. The primary objective of this pilot study was to evaluate the safety and acceptability of the ShangRing, a novel</div>\n<div>\n circumcision device, in boys below 18 years of age.</div>\n<div>\n <strong>Methods:</strong> A total of 80 boys, 3 months to 17 years old, were circumcised using the no-flip ShangRing technique. All rings</div>\n<div>\n were removed 5–7 days later. Participants were evaluated weekly until the wound was completely healed. Data on</div>\n<div>\n procedure times, adverse events (AEs), time to clinical wound healing and satisfaction were recorded and analysed.</div>\n<div>\n <strong>Results</strong>: Nearly all (79/80, 98.8%) circumcisions were successfully completed using the no-flip ShangRing technique without</div>\n<div>\n complications. In one (1.2%) case, the outer ring slipped off after the foreskin was removed and the procedure was</div>\n<div>\n completed by stitching. The mean circumcision and ring removal times were 7.4 ± 3.2 and 4.4 ± 4.2 min, respectively.</div>\n<div>\n There were four (5%) moderate AEs, which were managed conservatively. No severe AEs occurred. The mean time to</div>\n<div>\n complete clinical healing was 29.8 ± 7.3 days. Participants or their parents liked ShangRing circumcision because it improved</div>\n<div>\n hygiene, was quick and possessed an excellent cosmetic appearance. Most (72/80, 94.7%) were very satisfied with the</div>\n<div>\n appearance of the circumcised penis, and all (100%) said they would recommend circumcision to others.</div>\n<div>\n <strong>Conclusions</strong>: Our results suggest that no-flip ShangRing VMMC is safe and acceptable in boys below 18 years of age. Our</div>\n<div>\n results are to be compared those seen following ShangRing VMMC in African men. Further study with larger sample sizes are</div>\n<div>\n needed to explore the scalability of the ShangRing in larger paediatric cohorts in Africa. We believe that the ShangRing has</div>\n<div>\n great potential for use in all age groups from neonates to adults, which would simplify device implementation.</div>\n
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      • modified2019-12-10 12:33:33
      • created2013-04-18 13:04:19
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        • given_nameQuentin
        • middle_nameDavid
        • family_nameAwori
        • qualificationMBChB (UoN), Certified Phyisicain Investigar (ACRP), MPH (continuing)
        • professional_addressABC Place, Westlands. Waiyaki Way
        • telephone0722 913 616
        • emailQAwori@engenderhealth.org
        • created2013-04-18 13:26:21
        • modified2013-05-29 14:37:37
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        • created2013-04-18 13:26:21
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        • id60
        • application_id126
        • sponsorGrand Challenges Canada
        • sponsor_type(null)
        • contact_personWinnie Luong
        • addressMaRS Centre, South Tower 101 College Street, Suite 406 Toronto, ON, M5G 1L7 Canada
        • telephone_number416.673.6575
        • fax_number
        • cell_number416.673.6575
        • email_addresswinnie.luong@grandchallenges.ca
        • created2013-04-18 13:26:21
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      • 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