Table 1. Trial characteristics.
Trial | Product | Phase | Trial Duration | Population (age) | Total Enrollment | Location | Control Arm Incidence* |
---|---|---|---|---|---|---|---|
CAPRISA 004 [23] | TFV gel | IIb | 2007–2010 | Women (18–40) | 889 | South Africa | 9.1% |
TDF2 [9] | TDF-FTC | III | 2007–2011 | Women and Men (18–39) | 1219 | Botswana | 3.1% |
MTN 003 (VOICE) [24] | TDF-FTC, TDF, TFV gel | IIb | 2009–2012 | Women (18–45) | 5029 | South Africa, Uganda, Zimbabwe |
5.7% |
FEM-PrEP [25] | TDF-FTC | III | 2009–2013 | Women (18–35) | 2120 | Kenya, South Africa, Tanzania** | 5.0% |
FACTS 001 [26] | TFV gel | III | 2011–2014 | Women (18–30) | 2059 | South Africa | 4.0% |
IPM 027 (The Ring study) [27] | dapivirine ring | III | 2012–2016 | Women (18–45) | 1959 | South Africa, Uganda | 6.1% |
MTN 020 (ASPIRE) [28] | dapivirine ring | III | 2012–2015 | Women (18–45) | 2629 | Malawi, South Africa, Uganda, Zimbabwe | 4.5% |
*HIV infection rate in control arm per 100 person-years
**Researchers in Kenya and Tanzania could not be reached for interview and did not participate in the study.