RIFT: Effect of Rifampicin on Plasma PK of FTC, TAF and Intracellular TFV-DP & FTC-TP
Status:
Completed
Trial end date:
2018-01-10
Target enrollment:
Participant gender:
Summary
The purpose of this study is to look at the levels of three HIV medications: Descovy®,
Viread® and Rifadin® in the blood after drug intake has been stopped, in order to understand
how long these drugs persist in the blood. The study will specifically look at blood levels
of these three drugs after taking them every day for 28 days. Participants will take Descovy®
on a first stage, a combination of Descovy® and Rifadin® on a second stage, and Viread® on a
third stage. If the participants decide to take part, the duration of the study will be up to
85 days plus a screening visit which will take place up to 28 days prior to the start of the
study, and a follow up visit, which takes place 28 to 36 days after the last dose of study
medication. This study is not randomised which means that all participants will receive all
study medications in the same order. The participant and the study doctor will know which
study medications the participant is taking at all times during the study.
During the study, numerous blood samples will be taken which could cause inconvenience and
distress for patients. Every effort will be made by study staff to minimise this. There are a
lot of clinic visits during the study and three full days in the unit which may inconvenience
patients. However, participants will be made aware of this both verbally and in the patient
information sheet. Participants will also receive compensation for their time and travel
expenses whilst participating in the trial. Participants or participants' partners who plan
to become pregnant during the study will not be allowed to take part in the study. Further to
this (if applicable), participants must use effective contraception for the duration of the
study. Participants will have to adhere to other restrictions as detailed in the participant
information sheet. These restrictions will be explained in full to all participants.