Active — Not RecruitingPhase 3

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

Argentina, Belgium473 participantsStarted 2024-02-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. Fib-4 score \>3.25 is exclusionary;
✕. Fib-4 scores 1.45 - 3.25 requires Medical Monitor consultation.

What they're measuring

Percentage of participants with plasma HIV- Ribonucleic acid (RNA) less than (<)50 copies per milliliter (c/mL) as per snapshot algorithm at Week 48

Timeframe: Week 48

Trial details

NCT IDNCT05979311

SponsorViiV Healthcare

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-24

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