MedTrace Logo

RIFT: Effect of Rifampicin on Plasma PK of FTC, TAF and Intracellular TFV-DP & FTC-TP

NCT03186482 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2018-02-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Descovy® (TAF/FTC)

25/200 mg once daily for 28 days (DAYS 1-28).

DRUG

Viread® (TDF)

245 mg once daily for 28 days (DAYS 57-84).

DRUG

Rifadin® (Rifampicin)

600 mg once daily for 28 days (DAYS 29-56).

Sponsors & Collaborators

  • St. Stephens Clinical Research

    lead OTHER

Principal Investigators

  • Marta Boffito, MD MBBS · St Stephen's Clinical Research

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2018-01-10
Completion
2018-01-10

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03186482 on ClinicalTrials.gov