DAPIDAR v2.0
Research type
Research Study
Full title
A randomised, double blind phase I study to assess the safety, pharmacokinetics and pharmacodynamics of single and 14 days dosing with two vaginal microbicide formulations containing either Darunavir, or Dapivirine and Darunavir
IRAS ID
162681
Contact name
Charles Lacey
Contact email
Sponsor organisation
University of York
Eudract number
2014-003571-27
ISRCTN Number
DOI 10.1186/ISRCTN23353517
Duration of Study in the UK
0 years, 8 months, 11 days
Research summary
Scientists are trying to develop vaginal products that might be used by women which could stop them getting HIV infection through sexual intercourse. These are called microbicides. At the moment, there are two microbicides which are being tested in large clinical trials for this purpose. Both microbicides use drugs which work against HIV, known as anti-retrovirals (ARVs). Both of these microbicides just have one ARV (two different ones) in them. If there was a microbicide with two different ARVs in it, it might work better (be more effective) and it might be less likely to allow the HIV virus to become resistant (a possible danger when using only one ARV).
We want to do an early test of a microbicide which has two ARVs in it. One of the microbicides in a large clinical trial has the ARV Dapivirine in it. Another very good ARV is Darunavir, which is used widely as a tablet to treat people with HIV, but which has not been tested as a microbicide. We want to compare a microbicide which has a combination of Darunavir and Dapivirine in it, against a microbicide with only Darunavir in it.
We call our trial DAPIDAR, and it will test the safety of the two microbicides, and whether the ARVs will neutralise HIV in the vaginal secretions. We want to study the microbicides used, first of all just once, and then daily over two weeks, by 24 healthy volunteer women.REC name
London - Bloomsbury Research Ethics Committee
REC reference
14/LO/1762
Date of REC Opinion
7 Nov 2014
REC opinion
Further Information Favourable Opinion