HIV PREVENTION RESEARCH: TIMELINE OF EXPECTED EFFICACY TRIAL RESULTS*
Print
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 in 2011.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 -
iPrEx
Phase III trial of once-daily oral TDF/FTC (Brazil, Ecuador, Peru, South Africa, Thailand, US)
Showed that once-daily TDF/FTC reduced risk of HIV infection gay men, transgender women and other men who have sex with men an average of 43.8%. Results announced November 2010.December 2010
2011
-
FEM-PrEP
Phase III trial of a once-daily dose of TDF/FTC (Kenya, South Africa, Tanzania)
Study's data review committee determined that the trial would not be able to answer the question of whether the study drug decreased risk of HIV infection among HIV-negative women at risk via sexual transmission. The study will be discontinued.April 2011 -
PARTNERS PrEP
Phase III trial of once-daily oral TDF and once-daily oral TDF/FTC (Kenya, Uganda)
In July, DSMB recommended placebo arm discontinue after early data showed daily oral TDF reduced HIV by an estimated 62 percent and daily oral TDF/FTC reduced HIV risk by an estimated 73 percent when compared to placebo.
Active trial arms are still ongoing and will provide additional data in 2012 and 2013.
July 2011 -
TDF2 (CDC 4940)
Phase II trial of once-daily TDF/FTC (Botswana)
Analysis of the active and placebo arms indicated that daily oral TDF/FTC reduced the risk of HIV infection in both men and women participants by an estimated 62.6 percent compared to those who received the placebo.
August 2011
2012+
-
CDC 4370
Phase II/III trial of once-daily oral TDF (Thailand)January 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, 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.