TAP Trial
Research type
Research Study
Full title
The time to protection and adherence requirements of TRUVADA® and DESCOVY® required for protection from HIV-1 infection: bridging the data gaps
IRAS ID
221923
Contact name
Julie Fox
Contact email
Sponsor organisation
Guy's & St. Thomas' NHS Foundation Trust
Eudract number
2016-000439-42
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
There are new ways to stop people getting HIV. One of the most effective is to give medication called PrEP and is recommended by the World Health Organization (WHO). The most commonly used drug is Truvada. There is a new version of Truvada called Descovy, which is better tolerated than Truvada.
We would like to investigate whether Descovy is as good as Truvada in preventing HIV infection. We would like to know how quickly PrEP works after starting it and how quickly protection wears off once treatment is stopped. The final part of the study evaluates a way of giving PrEP called “on demand” PrEP which is taken around the time of sex. We will work out the best dosing regime for on demand sex.
In Part 1, participants will be randomised into one of six groups which decides the PrEP regime and timing of sampling visits. Participants will receive a 28-days of either Truvada or Descovy followed by a minimum 28 day wash out and then 28-days of the other PrEP. Samples will be taken at 5 time points. Part 2 evaluates the dosing requirements for on demand sex. Participants will receive Truvada or Descovy and given a specific dosing schedule followed by tissue sampling after stopping PrEP. Participants will then take the other PrEP regime after a minimum 21 day wash out and be sampled again.
Samples will be tested for drug levels and also tested to see if they can be infected with HIV. The results will provide useful tips for people who already take Truvada as PrEP,e.g. how quickly after starting PrEP that protection happens as well as how quickly after stopping PrEP that protection stops. We will also investigate whether these drugs affect the type of harmless bacteria called microbiome that is present in genital areas.REC name
London - City & East Research Ethics Committee
REC reference
19/LO/1911
Date of REC Opinion
19 Dec 2019
REC opinion
Favourable Opinion