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

NCT ID: NCT06497465

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-18
• Study Completion Date: 2029-01-31

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 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

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 concurrently in co-infected individuals, as there is a survival benefit for starting antiretroviral therapy (ART) soon after TB treatment initiation. Current Brazilian guidelines suggest that for patients with a cluster of differentiation 4 (CD4) < 50, ART should be started within 2 weeks of starting TB treatment; for patients with a CD4>50, ART should be started within 2 months of starting TB treatment. World Health Organization guidelines suggest ART initiation within 2 weeks of TB diagnosis regardless of CD4 count (provided there are no signs of TB meningitis), but most programs defer ART until 6-8 weeks in patients with CD4 >50 to reduce the risk of immune reconstitution inflammatory syndrome (IRIS).

The option of dual therapy for HIV (i.e., complete regimens to treat HIV composed of only 2 drugs) is of increasing interest and can lower costs for patients, payors, and programs while lowering cumulative lifetime exposure to ART (with potential resultant lessened burden of cumulative toxicities) and maintaining high antiviral efficacy. Based on the GEMINI, TANGO, and SALSA clinical trials, a regimen of 50 milligram (mg) DTG combined with 300mg lamivudine (3TC) has been shown to be a highly effective stand-alone option for the treatment of HIV-1 in ART treatment-naïve or virologically suppressed individuals through 48 weeks (SALSA) and 144 weeks (GEMINI and TANGO).

Conditions

Tuberculosis; HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1: DTG 50 mg/ 3TC 300mg (Dovato®) twice daily (BID)

Arm 1: DTG 50mg/3TC 300 mg fixed-dose-combination (FDC) tablet (Dovato®) twice daily during TB therapy and for 2 weeks after, then DTG 50mg/3TC 300 mg FDC tablet (Dovato®) once daily to week 52

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Arm 2: DTG 50 mg/ 3TC 300mg (Dovato®) once daily (QD) in the morning with DTG 50 mg in the evening

Arm 2: DTG 50mg/300mg FDC tablet plus DTG 50mg at night during TB treatment and for 2 weeks after, then DTG 50 mg/ 3TC 300 mg FDC tablet (Dovato®) once daily to week 52

Group Type: EXPERIMENTAL

Dolutegravir 50mg Tab

Intervention Type: DRUG

Participants will receive Dolutegravir 50mg

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

Intervention Type: DRUG

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

Arm 3: Standard of Care 3-drug ART (DTG+ TDF/3TC) plus DTG 50mg in the evening.

Arm 3: Local Standard of Care 3-drug ART (DTG 50mg + TDF/3TC) plus DTG 50 mg at night during TB treatment and for 2 weeks after, then DTG 50 mg + TDF/3TC FDC tablet once daily to week 52

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Interventions

Dolutegravir 50mg Tab

Participants will receive Dolutegravir 50mg

Intervention Type: DRUG

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

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

Intervention Type: DRUG

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

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

Intervention Type: DRUG

Other Intervention Names

TIVICAY 50 mg; TIVICAY PD

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ViiV Healthcare

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ethel M Weld, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Instituto Tropical de Doenças Infecciosas Manaus

Manaus, Amazonas, Brazil

Site Status: RECRUITING

Universidade Federal da Bahia

Salvador, Estado de Bahia, Brazil

Site Status: RECRUITING

FIOCruz

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status: RECRUITING

Hospital Geral de Nova Iguaçu

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status: RECRUITING

CePClin - Center for Studies and Research in Infectious Diseases Ltda

Natal, Rio Grande do Norte, Brazil

Site Status: RECRUITING

RDSS- Ricardo Diaz Solucoes Cientificas

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Beatriz M Kohler, RN

Role: CONTACT

bkohler@jhmi.edu

410 614 3812

Kate Boehner, RN

Role: CONTACT

kboehne1@jh.edu

Facility Contacts

Marcus Lacerda, MD, PhD

Role: primary

marcuslacerda.br@gmail.com

+55 92 99114-7633

Marcelo Cordeiro,,MD, PhD

Role: backup

+55 92 98533-3533

Carlos Brites, MD, PhD

Role: primary

crbrites@gmail.com

+55 71 992329552

Valeria Rolla, MD

Role: primary

valeria.rolla@ini.fiocruz.br

+55 21 99490-4251

Aline Benjamin, PhD

Role: backup

alinebenjaminipec@gmail.com

Aline Ramalho, MD

Role: primary

alineramalhopesquisa@gmail.com

+55 22 996107788

Mônica Bay B Bay, MD

Role: primary

monibay@gmail.com

+55 84 994141921

Sibele F Araújo

Role: backup

sibelearaujo@cpclinrn.com.br

Ricardo S Diaz, MD

Role: primary

rsdiaz@ricardodiaz.com.br

+55 21 99799 4412

Other Identifiers

IRB00441778

Identifier Type: -

Identifier Source: org_study_id