Dolutegravir/Lamivudine Dual Therapy for ART-naïve People With HIV and TB Receiving Rifampin-based TB Treatment
Recruiting · NCT06497465 · Interventional (participants receive a specific treatment) · Lead sponsor: Johns Hopkins University
View the official record on ClinicalTrials.gov →Interventions studied
Dolutegravir 50mg TabDolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC)Dolutegravir/Lamivudine 50 MG-300mg Oral Tablet [DOVATO]
What this trial is about
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 lamivudine either twice daily or DTG/3TC ( Dovato) in the morning +dolutegravir (DTG) in the evening, versus standard of care (SOC) twice-daily dolutegravir plus 2 once-daily Nucleoside reverse-transcriptase inhibitors (NRTIs) tenofovir disoproxil fumarate /lamivudine (TDF/3TC), among antiretroviral therapy (ART)-nave individuals with HIV-1 receiving rifampin-based TB therapy
Who can take part
Age range
15 Years to 99 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- Pregnant, or plans to become pregnant.
Where it is running
6 locations listed.
- Instituto Tropical de Doenças Infecciosas Manaus - Manaus, Amazonas, Brazil
- Universidade Federal da Bahia - Salvador, Estado de Bahia, Brazil
- CePClin - Center for Studies and Research in Infectious Diseases Ltda - Natal, Rio Grande do Norte, Brazil
- FIOCruz - Rio de Janeiro, Rio de Janeiro, Brazil
- Hospital Geral de Nova Iguaçu - Rio de Janeiro, Rio de Janeiro, Brazil
- RDSS- Ricardo Diaz Solucoes Cientificas - São Paulo, São Paulo, Brazil