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IPM 014A

Status
Completed
Phase
II
I
Principal Investigator(s)
Dr Annalene Nel
Objective

The purpose of this study is to determine whether dapivirine gel 4759 is safe for daily use by healthy women in Kenya, Malawi, Rwanda, South Africa and Tanzania.

Prevention Option(s)
Microbicides
Study Design
Randomized
Arms and Assigned Interventions
Description
dosage: 1.25mg dapivirine/day frequency: once daily duration: 6 weeks
Mode of Delivery
Gel
Products
dapivirine gel
ARMs
Experimental
Description
dosage form: vaginal gel frequency: once daily duration: 6 weeks
Mode of Delivery
Gel
ARMs
Placebo Comparator
Similar Trials
Trial Sponsors
IPM
September 2009
September 2011
Enrollment
280
18
Years
40
Years
Population
Women
Sites

Malawi College of Medicine John Hopkins University Clinical Research Site

Blantyre
Malawi

Project Ubuzima

Kiyivu, Kigali
Rwanda

Qhakaza Mbokodo Research Clinic

Ladysmith
South Africa

Prevention of HIV/AIDS (PHIVA) - Pinetown

Pinetown
South Africa

Madibeng Centre for Research

Brits
South Africa

Be Part Clinic, Mbekweni

South Africa

Ndlela HIV Research and Clinical Trials Unit

South Africa

Desmond Tutu HIV Foundation, Nyanga

South Africa

Kenya Medical Research Institute

Kenya