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Current Trials

CAPRISA 004 Results Lift Hope for Women’s HIV Prevention

Multiple candidate microbicides with different target pathogens and mechanisms of action must be tested simultaneously. This increases the probability and speed of finding a successful microbicide, and with time will lead to a variety of products with different attributes for different users. The table below summarizes those products that are currently beyond phase 1 in the clinical trails process globally.

MICROBICIDE CANDIDATES IN ONGOING CLINICAL TRIALS
(Does not include Phase 1)

Summary from July 2010

 

Trial Name

Phase

Candidate Name

          Sponsor*

Sites by Country

CAPRISA OO4 (results)

IIB

Tenofovir gel

CAPRISA, USAID, LIFElab, African Dept of Science and Technology, Gilead, FHI, CONRAD

South Africa

VOICE (MTN 003)

IIB

Tenofovir gel

CONRAD, DAIDS/NIAID, Gilead, MTN

South Africa, Uganda, United States

IPM 014A I/II Dapivirine gel IPM – safety and acceptability study Kenya, Malawi, Rwanda, South Africa, Tanzania
IPM 014B

I/II

 Dapivirine gel IPM - expanded safety study South Africa
IPM 020

I/II

 Dapivirine gel IPM - expanded safety study United States
IPM 015

I/II

 Dapivirine vaginal ring IPM - expanded safety study South Africa

II

 VivaGel® (SPL7013 gel) Starpharma United States
IPM 009

III

Dapivirine vaginal ring

IPM – efficacy and safety study

Africa (TBD)

Candidates in HIV-prevention trials in South Africa (more)

Many of the microbicide trials, including CAPRISA 004, are testing tenofovir.
Tenofovir is a highly specific nucleotide reverse transcriptase inhibitor (NRTI). It is an antiretroviral drug. An oral formulation of tenofovir (trade name Viread) is actively marketed by Gilead Sciences for the treatment of HIV. For potential microbicide use, tenofovir has been formulated as a 1% gel. It is likely to be highly potent, so it only takes a small amount of the active ingredient to have an effect. It is non-contraceptive and HIV specific.

For more information on clinical trials of tenofovir, additional candidate microbicide products, and other HIV-prevention products, please visit AVAC's Px Wire and Quarterly Update.