IPM 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 Clinical Trials Table
March 2014

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 Ongoing
IPM 028 Drug-drug interaction (Ring-004) Belgium 36 women Completed
IPM 029 Male condom functionality (Ring-004) United States ~70 couples Data Analysis
MTN 023 / IPM 030 Dapivirine ring safety (Ring-004) United States 96 females Ongoing
MTN 024 / IPM 031 Dapivirine ring safety and acceptability (Ring-004) United States 96 women Ongoing
IPM 033 Female condom functionality (Ring-004) United States ~80 couples Data Analysis
IPM 034 Dapivirine Ring PK (Ring-004) Belgium 40 women Data Analysis
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
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