Table 1.

Pre-Exposure Prophylaxis (PrEP) and Antiretroviral Drug-Based Microbicide Trials

Trial	Phase	Product Tested	Population	Status/Findings
CAPRISA 004	Phase IIB	1% tenofovir gel	889 women in South Africa	Results reported July 2010; tenofovir gel reduced risk of HIV infection by 39%
iPrEx	Phase III	Oral TDF/FTC	2499 gay men and other men who have sex with men and transgender women in Brazil, Ecuador, Peru, South Africa, Thailand, and the US	Results reported November 2010. TDF/FTC reduced risk of HIV by an average of 42%
FEM-PrEP	Phase III	Oral TDF/FTC	1951 heterosexual women in Kenya, South Africa, and Tanzania	Stopped for futility in April 2011, with 28 HIV infections in each arm. Full results expected early 2012
Partners PrEP	Phase III	Oral TDF and oral TDF/FTC	4758 scrodiscordant heterosexual couples in Kenya and Uganda	DSMB review in July 2011 showed daily TDF reduced risk of HIV by an average of 62%; daily TDF/FTC reduced risk of HIV by an average of 73%. As a result, placebo arms discontinued but the trial is ongoing. Additional data expected 2013
TDF2	Phase II	Oral TDF/FTC	1219 heterosexual men and women in Botswana	Results released July 2011. TDF/FTC reduced risk of HIV infection by an average of 63%
VOICE	Phase IIB	Oral TDF, oral TDF/FTC and 1% tenofovir gel	5029 women in South Africa, Uganda, and Zimbabwe	Oral TDF arm dropped for futility based on data from DSMB review. Other arms continuing. Full results expected early 2013
Bangkok Tenofovir	Phase II/III	Oral TDF	2400 injecting drug users in Bangkok, Thailand	Results expected 2012
iPrEx OLE	Openlabel extension	Oral TDF/FTC	Enrolling participants from iPrEx and ATN 082	Results expected 2013
FACTS 001	Phase III	1% tenofovir gel	Will enroll 3150 women in South Africa	Expected to begin in Q4 2011; Results expected 2013

DSMB, Data and Safety Monitoring Board; FTC, emtricitabine; TDF, tenofovir.

Reproduced with permission from AVAC: Global Advocacy for HIV Prevention.