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Clinical Trial Active — Not Recruiting Phase III NCT05979311

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

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…

📅 02 Jul 2026 ⏱ 1 min read
Active — Not Recruiting
Check the registry for current status and eligibility criteria.
Status
Active — Not Recruiting
Phase
Phase III
NCT ID
NCT05979311
Start
2024-02-21
Completion
2026-04-15
ClinicaliQ Trial Snapshot
  • 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….
  • Two-drug HIV treatment works as well as three-drug treatment, with simpler dosing and fewer side effects in treatment-naive adults.

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What This Trial Is Studying

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: Dolutegravir, Lamivudine, Bictegravir, Emtricitabine, Tenofovir alafenamide Lead Sponsor: ViiV Healthcare Planned Enrollment: 307 participants

Full Trial Details
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Eligibility criteria, protocol, and results when available
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