IPM 014A

Details

Protocol Title: A Double-Blind, Randomized, Placebo-Controlled Phase I/II Study to Evaluate the Safety and Acceptability of Dapivirine Gel 4759, 0.05% 2.5G, A Vaginal Microbicide, Conducted Using Daily Monitored Adherence in Healthy HIV-Negative Women

Status: Completed

Description

IPM 014A is a Phase I/II clinical trial designed to assess the safety and acceptability of one formulation of dapivirine gel (gel 4759, 0.05% 2.5g) as compared to a matching placebo gel in healthy, HIV-negative women in Kenya, Malawi, Rwanda and South Africa. 

The gel was used once a day for a period of six weeks.

The trial used the Daily Monitored Adherence (DMA) design, a model used to help women establish a pattern of routine product use.

Participating Research Centers

  • Be Part Yoluntu Centre — Mbekweni, South Africa
  • College of Medicine/Johns Hopkins Research Project — Blantyre, Malawi
  • Desmond Tutu HIV Foundation (DTHF) — Nyanga, South Africa 
  • Kenya Medical Research Institute (KEMRI) — Kisumu, Kenya
  • Madibeng Centre for Research (MCR) — Brits, South Africa
  • Prevention of HIV/AIDS Project (PHIVA) — Pinetown, South Africa
  • Projet Ubuzima — Kigali, Rwanda 
  • Qhakaza Mbokodo — Ladysmith, South Africa 

Publications, presentations or other scientific data

  • N/A