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A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy

NCT05979311 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 473

Last updated 2025-12-05

No results posted yet for this study

Summary

This study will compare safety, efficacy, participant reported outcomes and implementation outcomes of a fixed dose combination (FDC) of a two-drug regimen dolutegravir (DTG) plus lamivudine (3TC) and a three-drug regimen FDC of bictegravir (BIC), emtricitabine (FTC) and tenofovir alafenamide (TAF) in HIV-1 infected adult participants who have not previously received antiretroviral therapy.

Conditions

  • HIV
  • HIV Infections

Interventions

DRUG

Dolutegravir

Dolutegravir will be administered once daily.

DRUG

Lamivudine

Lamivudine will be administered once daily.

DRUG

Bictegravir

Bictegravir will be administered once daily.

DRUG

Emtricitabine

Emtricitabine will be administered once daily.

DRUG

Tenofovir alafenamide

Tenofovir alafenamide will be administered once daily.

Sponsors & Collaborators

  • ViiV Healthcare

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-09
Primary Completion
2026-03-24
Completion
2027-02-23

Countries

  • Argentina
  • Belgium
  • Denmark
  • France
  • Germany
  • Greece
  • Ireland
  • Israel
  • Italy
  • Japan
  • Mexico
  • Poland
  • Portugal
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05979311 on ClinicalTrials.gov