Clinical Trials

IPM’s clinical trials are carried out sequentially: first to determine the safety of a product and then to test its efficacy, or ability to prevent HIV infection. Our initial safety trials, Phase I trials, involve small numbers of women under carefully controlled clinical conditions. Expanded safety trials, Phase I/II, are then conducted to gain additional safety data among more participants over longer periods of time. When the safety trials are complete, longer-term safety and efficacy trials are conducted.

IPM conducts its clinical trials according to the highest safety and ethical principles, in partnership with researchers and communities.

Clinical Trials Table
November 2018

Monthly Dapivirine Ring
Trial Description Countries No* Status
IPM 001 Dapivirine ring safety (Ring-001) Belgium 12 women Completed
IPM 007 Seroconverter protocol South Africa, Uganda n/a Ongoing
IPM 008 Dapivirine ring safety (Ring-002) Belgium 13 women Completed
IPM 011 Placebo ring safety & acceptability South Africa, Tanzania 170 women Completed
IPM 013 Dapivirine ring PK (Ring-004) Belgium 48 women Completed
IPM 015 Dapivirine ring safety (Ring-004) Kenya, Malawi, South Africa, Tanzania 280 women Completed
IPM 018 Dapivirine ring PK (Rings 002 & 003) Belgium 24 women Completed
IPM 024 Dapivirine ring PK (Ring-004) Belgium 16 women Completed
IPM 027 (The Ring Study) Dapivirine ring long-term safety and efficacy (Ring-004) South Africa, Uganda 1950 women Completed
MTN-020 (ASPIRE)** Dapivirine ring safety and effectiveness (Ring-004) Malawi, South Africa, Uganda, Zimbabwe 2629 women Completed
IPM 028 Dapivirine ring drug-drug interaction (Ring-004) Belgium 36 women Completed
IPM 029 Dapivirine ring & male condom functionality (Ring-004) United States ~70 couples Completed
MTN 023 / IPM 030 Dapivirine ring safety (Ring-004) United States 96 females Completed
MTN 024 / IPM 031 Dapivirine ring safety and acceptability (Ring-004) United States 96 women Completed
IPM 032 (DREAM) Dapivirine ring (Ring-004) open-label safety and adherence South Africa, Uganda 1100 women Ongoing
MTN-025 (HOPE)** Dapivirine ring (Ring-004) open-label safety and adherence Malawi, South Africa, Uganda, Zimbabwe 1500 women Ongoing
IPM 033 Dapivirine ring & female condom functionality (Ring-004) United States ~80 couples Completed
IPM 034 Dapivirine Ring PK (Ring-004) Belgium 40 women Completed
IPM 035 Dapivirine ring & menses and tampon use (Ring-004) Belgium 32 women Completed
IPM 036 Dapivirine ring drug-drug interaction (Ring-004) Belgium 36 women Completed
MTN-029 / IPM 039 Dapivirine ring PK (Ring-004) United States 16 women Completed
MTN-034 (REACH)*** Dapivirine ring (Ring-004) and oral PrEP safety and adherence Kenya, South Africa, Uganda, Zimbabwe 300 females Planned
MTN-043 / IPM 051 Dapivirine ring (Ring-004) and oral PrEP safety and PK in breastfeeding women Malawi, South Africa, Uganda, Zimbabwe 100 women and infants Planned
MTN-042 / IPM 050 Dapivirine ring (Ring-004) and oral PrEP safety and PK in pregnant women Malawi, South Africa, Uganda, Zimbabwe 750 women Planned
Three-month Dapivirine Ring
Trial Description Countries No* Status
MTN-036/IPM 047 3-month dapivirine ring PK and safety (Ring-006, Ring-008) United States 48 women Ongoing
Dapivirine-Levonorgestrel Ring
Trial Description Countries No* Status
MTN-030/ IPM 041 Dapivirine-levonorgestrel ring PK and safety United States 24 women Completed
MTN-044/ IPM 053/ CCTN 019 Dapivirine-levonorgestrel ring PK and safety United States 24 women Ongoing
DS003 Tablet
Trial Description Countries No* Status
IPM 042 DS003 tablet safety Belgium 36 women Completed
Dapivirine-Maraviroc Combination Ring
Trial Description Countries No* Status
MTN 013 / IPM 026 Maraviroc, dapivirine, and dapivirine-maraviroc combination ring United States 48 women Completed
Dapivirine Film
Trial Description Countries No* Status
FAME-02*** Dapivirine film safety and PK United States 60 women Completed
FAME-02b** Dapivirine film safety and PK United States 10 women Completed
Dapivirine Gel
Trial Description Countries No* Status
IPM 003 Dapivirine gel safety (Gel-002) Rwanda, South Africa, Tanzania 112 women Completed
IPM 004 Dapivirine gel PK (Gel-002) South Africa 18 women Completed
IPM 005B Dapivirine gel safety (Gel-002) Belgium 36 women Completed
MTN 012 / IPM 010 Dapivirine gel male tolerance (Gel 4759) United States 48 men Completed
IPM 012 Dapivirine gel PK (Gels 4750 & 4789) Belgium 36 women Completed
IPM 014A Dapivirine gel safety (Gel 4759) Kenya, Malawi, Rwanda, South Africa 280 women Completed
IPM 014B Dapivirine gel safety (Gel 4789) South Africa 100 women Completed
IPM 020 Dapivirine gel safety (Gels 4759 & 4789) United States 128 women Completed
Maraviroc Gel
Trial Description Countries No* Status
CHARM-03** Maraviroc gel safety and PK United States 19 women and men Completed