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Safety and Efficacy of Switching From Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Safety and Efficacy of Switching From Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed

NCT02603120•Gilead Sciences

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate the efficacy of switching from a regimen of dolutegravir (DTG) and abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing DTG and ABC/3TC as the FDC ABC/DTG/3TC in virologically suppressed Human Immunodeficiency Virus- 1 (HIV-1) infected adults.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Estimated glomerular filtration rate ≥ 50 mL/min (≥ 0.83 mL/sec).
•Currently receiving an antiretroviral regimen of DTG + ABC/3TC, or ABC/DTG/3TC FDC for ≥ 3 months prior to the screening visit.
•HIV ribonucleic acid (RNA) \< 50 copies/mL at the screening visit.
•Currently on a stable regimen for ≥ 3 months preceding the screening visit with documented plasma HIV-1 RNA \< 50 copies/mL for ≥ 3 months preceding the screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL).
•Have no documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV), DTG, ABC or 3TC.

Exclusion Criteria

•Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance.
•Active tuberculosis infection.
•Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).
•Females who are pregnant.
•Females who are breastfeeding.
•Acute hepatitis in the 30 days prior to study entry.
•Chronic Hepatitis B Virus (HBV) infection.

Locations (94)

Phoenix, Arizona, United States

Beverly Hills, California, United States

Los Angeles, California, United States

Oakland, California, United States

Palm Springs, California, United States

Sacramento, California, United States

Key Dates

Start Date

November 11, 2015

Primary Completion Date

May 9, 2017

Completion Date

October 23, 2019

Last Updated

November 12, 2020

Enrollment

567

ACTUAL participants

Conditions

HIV-1 Infection

Interventions

ABC/DTG/3TC

DRUG

B/F/TAF

DRUG

ABC/DTG/3TC Placebo

DRUG

B/F/TAF Placebo

DRUG

Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI

NCT06602622

HIVHIV Associate Weight Loss+4 more

View study

COMPLETEDPHASE4

Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine

NCT06185452

HIV-1 Infection

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 12, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy of Switching From Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed

Inclusion Criteria

Exclusion Criteria

Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI

Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine

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