EDCTP funded HIV clinical studies in SSA Dr Thomas Nyirenda ICASA 2011 3-8 December 2011, Addis Ababa – Ethiopia –

Presentation lay out About EDCTP   About EDCTP Current geographical coverage of the partnership Remit of clinical trials EDCTP funds Funded projects (HIV vaccine, microbicide, MTCT and treatment) Barriers to conduct of HIV clinical trials in SSA EDCTP strategy to contribute to resolving the barriers Successes Gaps

The partnership (2003 – 2011) EDCTP-EEIG member states Austria Norway Belgium Portugal Denmark Spain France Sweden Germany Switzerland Greece United Kingdom Ireland Italy Luxembourg Netherlands Sub-Saharan African countries Benin Madagascar Botswana Malawi Burkina Faso Mali Cameroon Mozambique Congo Namibia Cote d’Ivoire Nigeria Democratic Republic of Congo Rwanda Ethiopia Senegal Gabon South Africa Ghana Sudan Guinea Tanzania Guinea-Bissau The Gambia Guinea-Conakry Uganda Kenya Zambia Liberia Zimbabwe

EDCTP Mission To fight poverty sub-Saharan Africa by accelerating the development of new or improved drugs, vaccines and microbicides against HIV/AIDS, malaria and tuberculosis, and to improve generally the quality of research in relation to these diseases Through equal and effective partnership with Africa and African researchers Through integration of EU Member States national health research programmes

EDCTP Scope

Vaccine projects PI Title of study and location Study product Status as of 2011 Bakari HIV vaccine trial capacity building in Tanzania and Mozambique by continued exploration of optimal DNA priming and MVA boosting strategies N/a On going Bekker Feasibility of and capacity building for adolescent vaccine trials in South Africa HPV vaccine Completed Hanke Building capacity of Infant HIV-1 Vaccine Clinical Trial Centres in Nairobi, Kenya and Fajara, The Gambia DNA MVA-HIVA Kaleebu Strengthening of long term clinical and laboratory research capacity, cohort development, and collection of epidemiological and social science baseline data in Uganda and Malawi to prepare for future HIV vaccine trials Kapiga Capacity development and strengthening in preparation for HIV vaccine trials in Tanzania and Burkina Faso Lyamuya HIV vaccine trial capacity building in Tanzania and Mozambique by continued exploration of optimal DNA and MVA boosting strategies; TaMoVac II DNA – MVA boost Weber African-European HIV Vaccine Development Network (Mozambique)

Microbicide projects PI Title of study and location Study product Status as of 2011 Hayes Site preparation and capacity strengthening for trials of vaginal microbicides in Tanzania and Uganda N/a Completed Mandaliya Characterisation of novel microbicide safety biomarkers in East and South Africa (Rwanda and Tanzania) N/a (Biomarkers) On going McCormack Establishing HIV microbicide clinical trial capacity in Mozambique and expanding and existing site in South Africa 0.5% and 2% PRO 2000/5 gels Wijgert Preparing for Phase III vaginal microbicide trials in Rwanda and Kenya: Preparedness studies, capacity building, and strengthening of medical referral systems

PMTCT projects PI Title of study and location Study product Status as of 2011 Katzenstein Back-up with Combivir (AZT/3TC) or single dose Truvada (FTC/TDF) in order to avoid Non Nucleoside Reverse Transcriptase Inhibitor (NNRTI) resistance after single dose Nevirapine for the prevention of mother-to-child transmission in Tanzania Combivir (AZT/3TC) or single dose Truvada (FTC/TDF) On going Kisanga Improving the balance between efficacy and development of resistance in women receiving single dose nevirapine (VIramune®, NVP) for the prevention of mother-to-child transmission in Tanzania & Zambia (VITA studies) Niverapine / Carbamezapine Leroy International phase 2b randomized clinical trial to study a once-a-day maintenance strategy after a 15-month induction antiretroviral therapy among HIV-infected children diagnosed early between age 6 and 52 weeks and in virologic success in Africa – Uganda, Cote d’Ivoire, Bukina Faso ABC/3TC/EFV or TDF-FTC-EFV) vs AZT/3TC/NVP Newell Impact of HAART during Pregnancy and Breastfeeding on MTCT and Mother’s Health: The Kesho Bora Study – South Africa, Kenya and Burkina Faso ZDV, 3TC, LPV/r, NVP Completed Van der Perre A phase III double blind placebo/controlled trial of the efficacy and safety of infant periexposure prophylaxis with lamivudine to prevent HIV-1 transmission by breastfeeding (PROMISE-PEP trial) – Burkina Faso, Uganda, Zambia and South Africa 3TC, LPV/r

HIV treatment projects PI Title of study and location Study product Status as of 2011 Mugyenyi The Eastern and southern Africa Research Network for Evaluation of Second Line Therapy in HIV infection: The EARNEST Trial - Aluvia (lopinavir/ritonavir co-formulated) - Truvada (co-formulation tenofovir emtricitabine) - Lamivudine - Abacavir - Tenofovir - Raltegravir On going Chintu Children with HIV in Africa - Pharmacokinetics and Adherence of Simple Antiretroviral Regimens Pedimune (Triomune Baby/Junior) tablets: stavudine (d4T), l amivudine (3TC) and nevirapine (NVP) Completed Mulenga Expanding the Availability of Fixed Dose Combination Antiretroviral Formulations for First-line Treatment of HIV-infected Children - the Children with HIV in Africa Pharmacokinetics and Acceptability/Adherence of Simple Antiretroviral Regimens CHAPAS-3 As above including ABC and EFV Delaporte A multicentre phase III trial of second-line antiretroviral treatment in African adults 1) Emtricitabine-tenofovir-lopinavir/ritonavir 2) Abacavir-didanosine- lopinavir/ritonavir 3) Emtricitabine-tenofovir-darunavir/ritonavir  2) Lamivudine-tenofovir-atazanavir/ritonavir

Barriers to conduct of international stand clinical research in sub-Saharan Africa   Lack of adequate and sustainable research funding Lack of a critical mass of well trained researchers Lack of adequate research infrastructure Lack of enabling environment for research (e.g. poor ethics and regulatory standards) Isolation of well trained cadres Lack of sharing of facilities and expertise Lack of mapping and synergising efforts Lack of common advocacy Invisible role of public sector

Future of HIV clinical trials in SSA -The EDCTP strategy

Future of HIV clinical trials in SSA – EDCTP Networks of Excellence Western Africa: WANETAM Project Coordinator: Prof. Soleymane Mboup Website: www.wanetam.org Burkina Faso Nigeria The Gambia Senegal Ghana United States Guinea-Bissau Mali Central Africa: CANTAM Project Coordinator: Prof. Francine Ntoumi Website: www.cantam.org Cameroon France Congo, Republic of the Germany Gabon Eastern Africa: EACCR Project Coordinator: Dr Pontiano Kaleebu Website: www.eaccr.org Kenya Germany Sudan Sweden Ethiopia United Kingdom Tanzania United States Uganda Southern Africa: TESA Project Coordinator: Dr Alexander Pym Website: www.tesafrica.org Botswana Zimbabwe  Malawi  France Mozambique  Germany South Africa  Netherlands Zambia  United Kingdom

Success of EDCTP funded projects   Increased scientific knowledge Infrastructure upgrade Training and mentorship of African researchers Networking (N-N, N-S and S-S) Provision of lessons and practical experience to ethics and regulatory bodies

Making a difference After Before

Success of funded projects   Increased scientific knowledge Infrastructure upgrade Training and mentorship of African researchers Networking (N-N, N-S and S-S) Provision of lessons and practical experience to ethics and regulatory bodies

Closing persistent gaps   More funding to sustain developed sites is required More finding for establishment of new sites is required Linkage of projects to programmes like NoE is required African governments need to start funding the developed sites and assume ownership Involvement of private sector needs stimulation

Closing persistent gaps  

Thank you http://www.edctp.org