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DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-naïve People Living With HIV-1 Infection

NCT06203132 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 610

Last updated 2026-01-07

No results posted yet for this study

Summary

Phase III trial evaluating doravirine as an alternative to dolutegravir in treatment naïve people living with HIV-1 infection.

Conditions

Interventions

DRUG

Dolutegravir + tenofovir DF + lamivudine or emtricitabine

Oral administration

DRUG

Doravirine + tenofovir DF + lamivudine

Oral administration

Sponsors & Collaborators

  • MSD France

    collaborator INDUSTRY

  • European and Developing Countries Clinical Trials Partnership (EDCTP)

    collaborator OTHER_GOV

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Principal Investigators

  • Pierre SELLIER, Dr · Assistance Publique - Hôpitaux de Paris

  • Beatriz GRINSZTEJN, Pr · INI-FIOCRUZ

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-27
Primary Completion
2026-11-30
Completion
2027-11-30

Countries

  • Brazil
  • Cameroon
  • Côte d’Ivoire
  • France
  • Mozambique
  • Thailand

Study Locations

More Related Trials

Entities

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 NCT06203132 on ClinicalTrials.gov