NCT03186482: RIFT

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

Completed Phase 1 Last updated 12 February 2018

What this trial tests

Phase 1 trial testing Descovy® (TAF/FTC) in HIV in 21 participants. Completed in 10 January 2018.

Timeline

1 June 2017

Primary endpoint
10 January 2018

10 January 2018

Quick facts

Lead sponsor	St. Stephens Clinical Research
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	single
Primary purpose	health services research
Enrollment	21
Start date	1 June 2017
Primary completion	10 January 2018
Estimated completion	10 January 2018
Sites	1 location across United Kingdom

Drugs / interventions tested

• Descovy® (TAF/FTC) — full drug profile →
• Viread® (TDF) — full drug profile →
• Rifadin® (Rifampicin) — full drug profile →

Conditions studied

• HIV — all drugs for HIV →

Sponsor

St. Stephens Clinical Research

Who can join

Adults 18 to 60, any sex, with HIV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Rifampicin effect on intracellular and plasma pharmacokinetics of tenofovir alafenamide.
   Cerrone M, Alfarisi O, Neary M, Marzinke MA, et al · · 2019 · cited 45× · PMID 30815689 · DOI 10.1093/jac/dkz068
2. Pharmacological impact of antiretroviral therapy on platelet function to investigate human immunodeficiency virus-associated cardiovascular risk.
   Taylor KA, Smyth E, Rauzi F, Cerrone M, et al · · 2019 · cited 19× · PMID 30681136 · DOI 10.1111/bph.14589