Oral tenofovir (TFV) is an effective HIV prevention tool with activity against other viruses, such as herpes simplex virus (HSV); however, uptake and use of TFV as PrEP as well as long-term adherence have been variable and indicate a need for alternative delivery of PrEP therapy. CONRAD has developed an intravaginal ring (IVR) that releases TFV in a controlled and sustained manner for at least 90 days. A completed Phase I study in women showed no safety concerns of the TFV IVR, met pharmacokinetic (PK) TFV benchmarkers, and demonstrated high concentrations of the active metabolite of TFV and effective activity against HIV-1.
This study is designed to assess the clinical and pharmacologic safety of each of TFV-only and TFV/levonorgestrel (LNG)-combination IVR compared to placebo following 90 days of continuous use. Additionally, tolerability, acceptability, and adherence as well as the acceptability of each IVR will be assessed.
This is a first-in-Africa study to evaluate the combination TFV/LNG IVR for HIV/HSV prevention and long-acting contraception and the TFV-only IVR for HIV/HSV prevention.