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
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
| Condition | HIV I Infection |
|---|---|
| Treatment | Dolutegravir / Lamivudine Pill, Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill |
| Clinical Study Identifier | NCT04585737 |
| Sponsor | Charlotte-Paige Rolle, MD |
| Last Modified on | 27 June 2022 |
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