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HIV Prevention Research & Development in South Africa

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HIV Prevention Research & Development in South Africa HIV Prevention Research & Development in South Africa June 2015 South Africa has a long history of HIV prevention research and continues to play a leading role in developing and implementing a range of HIV prevention research. South African researchers, research sites and thousands of volunteers have participated these endeavors. Such research ensures that potential products are tested in hard-hit populations where new strategies are urgently needed. These same populations can benefit from interventions that show efficacy and are licensed for use. The map below and the table on the following pages lists all biomedical HIV prevention studies recently completed, currently ongoing or planned in the country. As the graphic illustrates, there are approximately 19 ongoing trials taking place in 12 different locations in South Africa. For information on each trial and the research organizations leading on them, please visit the HIV Prevention Research & Development Database (PxRD) www.avac.org/pxrd. To learn more about AVAC’s partners and projects in South Africa, please visit www.avac.org. Ongoing Biomedical HIV Prevention Trials Sites in South Africa PREVENTION Antibodies Long-acting injectable ARVs R Rectal tenofovir gel VMMC OPTIONS Tenofovir gel Dapivirine ring Treatment as prevention Preventive vaccines Oral PrEP Johannesburg Klerksdorp Brits Pretoria MTN 020 HVTN 086/SAAVI103 IPM 027 START HVTN 100 TAPS Demo Project IPM 007 START HPTN 071 HPTN 052 Hlabisa ANRS 12249 HPTN 077 Brits HVTN 086/SAAVI103 Pretoria Ladysmith HIV-V-A004 Johannesburg IPM 027 Cape Town Soweto IPM 007 Klerksdorp Hlabisa ADAPT (HPTN 067) Ladysmith Soweto Sibanya Health Project HVTN 097 Pietermaritzburg Pietermaritzburg Pinetown Pinetown Anova Health4Men CAPRISA 008 IPM 027 HVTN 100 Plessislaer HPTN 076 Durban IPM 007 HIV-V-A004 MTN 020 CHAMPS R MTN 017 Durban CHAMPS MTN 020 Cape Town Port Elizabeth HPTN 071 CAPRISA 008 START START HVTN 086/SAAVI103 HPTN 077 Plessislaer HVTN 097 Port Elizabeth IPM 027 HVTN 100 HVTN 100 Sibanya IPM 007 HIV-V-A004 HIV-V-A004 June 2015 Page | 1 HIV Prevention Trials in South Africa Key completed trials since 2010 and all ongoing and planned trials taking place in South Africa Trial Phase Study Drug Funder, Sponsor Sites Population Status/Results Oral PrEP BMGF; National partners, in Combination collaboration with the The TAPS Demo prevention and O’Neill Institute of Ongoing; started Q2 2015. Expected Demonstration Johannesburg Female sex workers Project care approach, Georgetown University, completion Q2 2017. Project including PrEP LSHTM, Imperial College London, UNAIDS and WHO Choices for Adolescent Combination Ongoing; Pluspills project is expected Methods of Demo prevention and Cape Town, Heterosexual men to complete in Q4 2016; UChoose NIAID Prevention in Project care approach, Soweto and women project is expected to complete in Q2 South Africa including PrEP 2016. (CHAMPS) Sibanya Health Rollins School of Public Project: Health, Johns Hopkins Comprehensive HIV Combination Demo prevention and School of Public Health, Cape Town, Port Ongoing; started in Q4 2014. Prevention MSM Project care approach, Desmond Tutu HIV Elizabeth Expected completion Q2 2016. Package for MSM including PrEP Foundation; Emory in Southern Africa University Pilot Study Anova Health Anova Health Institute, Institute’s Demo Desmond Tutu HIV Rollout of PrEP Cape Town MSM Status TBD Health4Men Project Foundation; Elton John initiative AIDS Foundation Ongoing; full results currently being analyzed and expected Q2 2015. MSM, transgender Preliminary results from women in Phase II ADAPT Daily oral women and Cape Town show daily dosing open DIADS, Gilead, HPTN, NIMH Cape Town (HPTN 067) TDF/FTC heterosexual fostered better adherence, better label women coverage of potential sexual exposure, and more sustained use of PrEP by South African women. Completed Q3 2014; Results show PrEP provides a high degree of Cape Town (Brazil, protection against HIV infection, even Open Daily oral Ecuador, Peru, for individuals who miss some daily iPrEx OLE NIAID, BMGF MSM label TDF/FTC Thailand and the doses; high Interest in PrEP; longer- US) term evidence of safety and efficacy; and no sign of increased risk behavior among PrEP users Cape Town (Brazil, Completed Q3 2010; TDF/FTC found Daily oral Ecuador, Peru, Transgender women iPrEx III BMGF; NIAID effective, participants rolled over into TDF/FTC Thailand and the and MSM OLE. US) Pretoria, Josha Halted Q2 2011; interim data review Daily oral Heterosexual FEM-PrEP III USAID, BMGF; FHI 360 (Kenya and found equivalent HIV rates in active TDF/FTC women Tanzania) and placebo arm. Completed Q3 2012; daily oral Johannesburg, Daily oral TDF; tenofovir, daily oral TDF/FTC and Durban, Tongaat, daily oral CONRAD, Gilead, MTN, Heterosexual daily 1% tenofovir gel did not MTN 003 (VOICE) IIb Klerksdorp TDF/FTC ; 1% NIAID, NICHD, NIMH women provided additional protection against (Uganda and tenofovir gel HIV, likely because few women in the Zimbabwe) June 2015 Page | 2 trial used the products as directed. Trial Phase Study Drug Funder, Sponsor Sites Population Status/Results Dapivirine Ring Cape Town, Durban, Monthly vaginal Johannesburg (Malawi, Heterosexual Ongoing; results expected MTN 020 III MTN, CONRAD, NIH, Gilead dapivirine ring Uganda, Zambia, women Q1 2016. Zimbabwe) Monthly vaginal Ladysmith, Pinetown, Heterosexual Ongoing; results expected IPM 027 III IPM dapivirine ring Brits, Plessislaer (Uganda) women Q4 2016. Long-term follow-up Heterosexual Observationa study for participants Ladysmith, Pinetown, Ongoing; expected IPM 007 IPM women l who become HIV + Brits, Plessislaer (Uganda) completion Q4 2015. during IPM 027 Ladysmith, Pinetown, Heterosexual Planned; anticipated start Ring OLE OLE Monthly vaginal IPM Brits, Plessislaer (Uganda) women Q1 2017. Johannesburg, Cape Planned; anticipated start MTN 025 Follow-on for vaginal Heterosexual IIIB MTN Town, Durban (Malawi, Q2 2016. (HOPE) dapivirine ring women Uganda, Zimbabwe) Edendale, Ladysmith, Completed Q3 2011; found Monthly vaginal Pinetown, Brits, Cape Heterosexual IPM 015 I/II IPM monthly dapivirine ring is dapivirine ring Town, Paarl, (Malawi, women safe. Kenya and Tanzania) Completed Q1 2010; found Monthly placebo Durban, Johannesburg, Heterosexual IPM 011 Open label IPM monthly dapivirine ring is silicone vaginal ring Nyanga (Tanzania) women safe and acceptable. R Vaginal and Rectal Tenofovir Gel Pietermaritzburg, Cape Town, 1% tenofovir gel, BMGF, CONRAD, South Completed Q1 2015; found Witwatersrand, Hillbrow, Heterosexual FACTS 001 III applied 12 hours Africa DST, South Africa no effect for 1% vaginal Ladysmith, Pretoria, women before and after sex National DOH, USAID tenofovir gel overall Rustenburg, Soshanguve, Tembisa CAPRISA, MACAIDS 1% tenofovir gel, through Tides Foundation, CAPRISA Heterosexual Ongoing; results expected III applied 12 hours South African DST through Durban, Pietermaritzburg 008 women Q2 2015. before and after sex TIA, USAID through CONRAD Transgender Reformulated rectal CONRAD, Gilead, MTN, Cape Town (Peru, Ongoing; results expected MTN 017 II women and 1% tenofovir gel NIAID, NIMH Thailand and the US) Q1 2016. MSM Completed Q3 2012; daily oral tenofovir, daily oral TDF/FTC and daily 1% Daily oral TDF; Johannesburg, Durban, Heterosexual tenofovir gel did not MTN 003 CONRAD, Gilead, MTN, IIb daily oral TDF/FTC ; Tongaat, Klerksdorp women provided additional (VOICE) NIAID, NICHD, NIMH 1% tenofovir gel (Uganda and Zimbabwe) protection against HIV, likely because few women in the trial used the products as directed. Completed Q3 2010; found 1% tenofovir gel, vaginal 1% tenofovir gel CAPRISA CAPRISA, CONRAD, FHI Heterosexual II applied 12 hours Durban, Pietermaritzburg 12 hours before and after 004 360, USAID women before and after sex sex reduces women's HIV risk by 39%. Paarl, Ladysmith, Pinetown, Agincourt, Daily dapivirine gel Heterosexual Completed Q1 2011; found IPM 014A I/II IPM Brits, Cape Town, applied once daily women daily dapivirine gel safe. (Malawi, Rwanda, Kenya and Tanzania) IPM 014B I/II Daily dapivirine gel IPM Paarl, Brits, Cape Town Heterosexual Completed Q3 2010; no applied once daily women data published.June 2015 Page | 3 Trial Phase Study Drug Funder, Sponsor Sites Population Status/Results Long-Acting Injectable Antiretrovirals (ARVs) Bill and Melinda Gates Cape Town (US, Heterosexual Ongoing; results HPTN 076 II Long acting TMC278 Foundation; NIAID; Zimbabwe) women expected Q4 2017. PATH Durban, Heterosexual Ongoing; results HPTN 077 IIa Long acting GSK744 NIAID Johannesburg women expected Q3 2017 (Brazil, Malawi, US) Preventive Vaccines HVTN, Bill and Melinda ALVAC/gp120 Gates Foundation, MRC, Cape Town, Durban, Women and Ongoing; expected HVTN 100 I/II MF59 adjuvant Sanofi Pasteur, Novartis Klerksdorp, Soweto men completion Q3 2016. Vaccines; NIAID Cape Town, Durban, NIAID, US MHRP, Beth Johannesburg, Israel Deaconess Women and Ongoing; expected HIV-V-A004 I/II Ad26/MVA/gp140 Soweto (Rwanda, Medical Center, IAVI; men completion Q2 2019. Thailand, Uganda, Crucell Holland US) ALVAC-HIV, AIDSVAX B/E, Cape Town, Soweto Women and Ongoing; results HVTN 097 I Tetanus toxoid (Tetavax), NIAID, Novartis, SAAVI (also US) men expected Q2 2016. Hepatitis B (ENGERIX-B) SAAVI DNA-C2, SAAVI Johannesburg, HVTN 086/ MVA-C and Novartis Sub Women and Ongoing; results I SAAVI, HVTN, Novartis Klerksdorp, Cape SAAVI 103 C gp140 with adjuvant men expected Q2 2015. Town MF59 ALVAC/gp120 Sites in South Africa Women and Planned; anticipated
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