Status:
RECRUITING
Dolutegravir/Lamivudine Dual Therapy for ART-naïve People With HIV and TB Receiving Rifampin-based TB Treatment
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
ViiV Healthcare
Conditions:
Tuberculosis
HIV
Eligibility:
All Genders
15-99 years
Phase:
PHASE3
Brief Summary
This will be a Phase IIIb Clinical Trial, an international multicenter, randomized, three-arm, non-comparative trial of efficacy, safety, and tolerability of the dual therapy regimen dolutegravir plus...
Detailed Description
Tuberculosis (TB) is the most common cause of death in people with HIV worldwide. Among patients with HIV, the incidence of TB per year is about 5-10%. The two diseases are now always treated concurre...
Eligibility Criteria
Inclusion
- Documentation of HIV-1 status: HIV-1 infection, documented by any licensed rapid HIV test or HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, or plasma HIV 1 RNA viral load. Two or more HIV-1 RNA viral loads of \>1,000 copies/mL are also acceptable as documentation of HIV-1 infection.
- CD4+ cell count ≥50 cells/mm3 obtained within 30 days prior to study entry
- HIV-1 viral load ≥1000 copies/mL
- ART-naïve.
- Documentation of pulmonary TB
Exclusion
- Pregnant, or plans to become pregnant.
Key Trial Info
Start Date :
September 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2029
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06497465
Start Date
September 18 2025
End Date
January 31 2029
Last Update
September 24 2025
Active Locations (6)
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1
Instituto Tropical de Doenças Infecciosas Manaus
Manaus, Amazonas, Brazil, 69040-000
2
Universidade Federal da Bahia
Salvador, Estado de Bahia, Brazil, 40110-160
3
FIOCruz
Rio de Janeiro, Rio de Janeiro, Brazil, 21040-360
4
Hospital Geral de Nova Iguaçu
Rio de Janeiro, Rio de Janeiro, Brazil, 26210-190