NCT04585737

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

Efficacy, Safety and Tolerability of Switching to Dolutegravir/Lamivudine in Virologically-suppressed Adults Living With HIV on Bictegravir/Tenofovir Alafenamide/emtricitabine-the DYAD Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: Charlotte-Paige Rolle, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• HIV I Infection

Interventions

Type	Name	Description
DRUG	Dolutegravir / Lamivudine Pill	Experimental
DRUG	Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill	Active comparator

Timeline

• Start date: 2020-10-05
• Primary completion: 2023-08-03
• Completion: 2023-08-10
• First posted: 2020-10-14
• Last updated: 2024-10-17
• Results posted: 2024-10-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study