Efficacy of Switching to DTG/3TC in Virologically-suppressed Adults Currently on B/F/TAF

  • STATUS
    Recruiting
  • participants needed
    222
  • sponsor
    Charlotte-Paige Rolle, MD
Updated on 8 August 2022

Summary

Phase 4, randomized, open-label study to evaluate the efficacy, safety and tolerability of switching virologically suppressed adults living with HIV on bictegravir/tenofovir alafenamide/emtricitabine to dolutegravir/lamivudine

Description

Randomized, open-label, active-controlled study of virologically suppressed participants living with HIV

Participants who provide written informed consent and meet all the eligibility criteria will be randomized in a 2:1 ratio to one of the following 2 treatment groups:

Treatment Group 1 (n=148): FDC of DTG/3TC (50mg/300mg) administered orally, once daily (QD), without regard to food.

Treatment Group 2 (n=74): Stay on baseline regimen consisting of FDC of B/F/TAF (50mg/200mg/ 25mg) (taken as prescribed) without regard to food.

Randomization will be stratified by gender and race at entry given that this study aims to enroll at least 30% of participants who are female and African American.

All participants will be responsible for using their insurance plan to obtain coverage for DTG/3TC and or B/F/TAF, in addition to any labs required by the study. This expectation is clearly outlined in the informed consent. The study team will work with participants to minimize their co-pays for study medications and labs through the use of manufacturer and other external assistance programs.

Study duration will be 48 weeks.

Number of participants planned: Approximately 222 participants

Target Population: HIV-1 infected adult participants who are virologically suppressed (HIV-1 RNA<50 copies/mL) on FDC of B/F/TAF (50mg/200mg/ 25mg) 3 months prior to screening

Details
Condition HIV I Infection
Treatment Dolutegravir / Lamivudine Pill, Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill
Clinical Study IdentifierNCT04585737
SponsorCharlotte-Paige Rolle, MD
Last Modified on8 August 2022

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