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

Phase 4

Completed

• Conditions: HIV I Infection
• Interventions: Drug: Dolutegravir / Lamivudine Pill; Drug: Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill

• Registration Number: NCT04585737
• Lead Sponsor: Charlotte-Paige Rolle, MD

Brief 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

Study Timeline

• Study First Submitted: 2020-09-22
• Study Start: 2020-10-05
• Study First Submitted QC: 2020-10-07
• Study First Posted: 2020-10-14
• Primary Completion: 2023-08-03
• Study Completion: 2023-08-10
• Results First Submitted: 2024-08-29
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-24
• Last Update Submitted: 2024-09-24
• Results First Posted: 2024-10-17
• Last Update Posted: 2024-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group 1	Dolutegravir / Lamivudine Pill	Treatment Group 1 (n=148): FDC of DTG/3TC (50mg/300mg) administered orally, once daily (QD), without regard to food.
Treatment group 2	Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill	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.

Primary Outcome Measures

Name	Time	Method
The Primary Outcome Measure is to Evaluate the Efficacy of Switching From B/F/TAF to DTG/3TC Versus Continuing B/F/TAF as Determined by the Proportion of Participants With HIV-1 RNA ≥50 Copies/mL at Week 48	48 weeks	percentage with HIV-1 RNA ≥50 copies/mL at Week 48 in each treatment arm

Secondary Outcome Measures

Name	Time	Method
The Secondary Outcome Measure is to Evaluate the Efficacy of Switching to DTG/3TC From B/F/TAF as Determined by the Proportion of Participants With HIV-1 RNA≥ 50 Copies/mL at Week 24	24 weeks	percentage with HIV-1 RNA ≥50 copies/mL at Week 24 in each treatment arm
The Secondary Outcome Measure is to Evaluate the Efficacy of Switching to DTG/3TC From B/F/TAF as Determined by the Proportion of Participants With HIV-1 RNA<50 Copies/mL at Week 48	48 weeks	percentage with HIV-1 RNA\<50 copies/mL at Weeks 12, 24 and 48 in each treatment arm
The Secondary Outcome Measure is to Measure the Incidence and Severity of Grade 2-5 Drug-related Adverse Events and Laboratory Abnormalities (Graded Using DAIDs Grading Scale) Through 48 Weeks	48 weeks	Grade 2-5 drug-related AEs and lab abnormalities graded using DAIDS grading scale
The Secondary Outcome Measure is to Evaluate the Proportion of Participants That Discontinue Treatment Through 48 Weeks in Each Treatment Arm and Reasons for Discontinuation	48 weeks	Number of participants who discontinue study treatment and reasons for discontinuation
The Secondary Outcome Measure is to Evaluate the Effects of DTG/3TC Once Daily on Fasting Total Cholesterol Over Time Compared to B/F/TAF Through 48 Weeks	48 weeks	Change from Baseline in fasting total cholesterol at Week 48
The Secondary Outcome Measure is to Evaluate Changes in Weight (kg) in Those Treated With DTG/3TC vs. B/F/TAF Over Time	48 weeks	Change from Baseline in weight (kg) measured at Week 48
The Secondary Outcome Measure is to Evaluate Changes in Waist Circumference (Inches) in Those Treated With DTG/3TC vs. B/F/TAF Over Time	48 weeks	Change from Baseline in waist circumference (measured in inches) at Week 48
The Secondary Outcome Measure is to Evaluate Changes in BMI (kg/m2) in Those Treated With DTG/3TC vs. B/F/TAF Over Time	48 weeks	Change from Baseline in weight (kg) and height (meters) will be used to assess changes in BMI (kg/m2) measured at Week 48
To Assess the Number of Subjects With Genotypic Mutations Affecting Any Component of the Treatment Regimen Among Subjects Meeting Virologic Rebound Criteria (HIV-1 RNA≥50 Copies/mL X2) Using HIV Genotypic and ARCHIVE HIV-DNA Testing	48 weeks	to measure the incidence of observed genotypic resistance to ARVs for subjects meeting Virologic Rebound Criteria

Trial Locations

Locations (1)

Orlando Immunology Center; 🇺🇸 Orlando, Florida, United States