HIV PREVENTION RESEARCH: TIMELINE OF EXPECTED EFFICACY TRIAL RESULTS*
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2007
-
MIRA
Phase III trial of the female diaphragm (South Africa, Zimbabwe)
No evidence of benefit. Results announced July 2007.March 2007 -
STEP (HVTN 502/MERCK 023)
Phase IIb trial of MRK-Ad5 HIV vaccine candidate (Australia, Brazil, Canada, Dom. Rep., Haiti, Jamaica, Peru, Puerto Rico, US)
Trial halted immunizations, September 2007. Data analysis found no evidence of benefit and potential for increased risk of HIV infection among Ad5-seropositive, uncircumcised men. Follow-up continues.April 2007 -
PHAMBILI (HVTN 503)
Phase IIb trial of MRK-Ad5 HIV vaccine candidate (South Africa)
Trial halted enrollment and immunizations, September 2007, following Step trial announcement. Follow-up continues.May 2007
2008
-
HSV-2 SUPPRESSION (HPTN 039)
Phase III trial of suppressive acyclovir treatment for the reduction of HIV infection in HSV-2 seropositive individuals (Peru, South Africa, US, Zambia, Zimbabwe)
No evidence of benefit. Results announced February 2008.January 2008 -
MALE CIRCUMCISION IN HIV-POSITIVE MEN
Large-scale trial of male circumcision for HIV-positive men and its potential protective effect for HIV-negative female partners of HIV-positive circumcised males (Uganda)
Trial stopped enrollment, December 2006. No statistically significant conclusions could be drawn from sample size. However, men who resumed sex prior to wound healing were more likely to transmit HIV to their female partners. Preliminary results announced February 2008; published July 2009.February 2008 -
CARRAGUARD
Phase III trial of the microbicide Carraguard (South Africa)
No evidence of benefit. Results announced February 2008.March 2008
2009
-
HPTN 035
Phase II/IIb trial of two microbicides, BufferGel and 0.5% PRO 2000/5 gel (Malawi, South Africa, US, Zambia, Zimbabwe)
There were fewer infections in women using PRO 2000 than in women using the placebo gel, but this difference was not statistically significant. No evidence of benefit was found for women using BufferGel. Results announced February 2009.January 2009 -
PARTNERS IN PREVENTION
Phase III study of suppressive acyclovir treatment for HSV-2 on HIV transmission (Botswana, Kenya, Rwanda, South Africa, Tanzania, Uganda, Zambia)
No evidence of reduced rates of HIV transmission, but there were reduced rates of genital ulcers and HIV viral load. Results announced May 2009.February 2009 -
ALVAC-AIDSVAX (RV 144)
Phase III trial of a prime-boost vaccine strategy ALVAC plus AIDSVAX (Thailand)
Initial data show that vaccine recipients were 31% less likely than placebo recipients to become HIV-infected. There was no observed effect on viral load. Additional data analysis is ongoing.March 2009 -
MDP 301
Phase III trial of the vaginal microbicide PRO 2000 (South Africa, Tanzania, Uganda, Zambia)
No evidence of benefit. Results announced November 2009.April 2009
2010
-
CDC 4323
Phase II trial of once-daily oral TDF (US)
The trial reported no serious adverse events and preliminary data show PrEP use did not have a significant effect on HIV risk behavior. Additional data expected Q4 2010.January 2010 -
CAPRISA 004
Phase IIb trial of the vaginal microbicide tenofovir gel (South Africa)
There were 39 percent fewer infections among women who received 1% tenofovir gel compared to women who received the placebo gel. Results announced July 2010.February 2010 -
CDC 4940
Phase III trial of once-daily TDF/FTC (Botswana)March 2010
2011
2012+
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PARTNERS PrEP
Phase III trial of once-daily oral TDF and once-daily oral TDF/FTC (Kenya, Uganda)February 2012 -
FEM-PrEP
Phase III trial of a once-daily dose of TDF/FTC (Kenya, Malawi, South Africa, Tanzania, Zimbabwe)March 2012 -
HVTN 505
Phase II of the VRC's DNA prime / Ad5-boost vaccine strategy on post-HIV infection viral (US)April 2012 -
VOICE (MTN-003)
Phase IIb trial of once-daily oral TDF, once-daily oral TDF/FTC, and 1% tenofovir gel (South Africa, Uganda, Zimbabwe)May 2012 -
HPTN 052
Phase III trial of ARV therapy and HIV primary care versus HIV primary care alone in HIV-serodiscordant couples (Botswana, Brazil, India, Kenya, Malawi, South Africa, Thailand, US, Zimbabwe)June 2012
*The trial end-dates listed in this table are estimates. Due to the nature of clinical trials the actual dates may change. AVAC will continue to monitor the trial's progress and will update the timeline accordingly.