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RECRUITINGPhase 3INTERVENTIONAL

Dolutegravir/Lamivudine Dual Therapy for ART-naïve People With HIV and TB Receiving Rifampin-based TB Treatment

Dolutegravir Plus Lamivudine (DTG/3TC) Dual Therapy Versus Dolutegravir With TDF-lamivudine (DTG + TDF/3TC) Among Antiretroviral naïve People With HIV and TB Receiving Rifampin-based TB Treatment

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - Pregnant, or plans to become pregnant. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Dolutegravir 50mg Tab

Participants will receive Dolutegravir 50mg

DRUG

Dolutegravir/Lamivudine 50 MG-300mg Oral Tablet [DOVATO]

Participants will receive Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet \[DOVATO\]

DRUG

Dolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC)

Participants will receive Dolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC)

Locations (6)

Instituto Tropical de Doenças Infecciosas Manaus
Manaus, Amazonas, Brazil
Universidade Federal da Bahia
Salvador, Estado de Bahia, Brazil
FIOCruz
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital Geral de Nova Iguaçu
Rio de Janeiro, Rio de Janeiro, Brazil
CePClin - Center for Studies and Research in Infectious Diseases Ltda
Natal, Rio Grande do Norte, Brazil
RDSS- Ricardo Diaz Solucoes Cientificas
São Paulo, São Paulo, Brazil