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

NCT06497465 | Recruiting Phase 3 DMC

• 1 other identifier: IRB00441778
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 6

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

Conditions

Tuberculosis; HIV

Outcome Measures

Primary Outcomes (1)

• Among treatment-naïve participants with HIV-1 who are taking rifampin-based regimens for TB, determine the proportion with HIV-1 virologic suppression (via FDA snapshot algorithm) at 28 weeks of HIV treatment, by arm

  To Compare the proportion of participants with HIV-1 virologic suppression at 28 weeks of HIV treatment by arm.

  28 weeks

Secondary Outcomes (6)

• 1.3.1 Number of patients with HIV-1 virologic suppression (via FDA snapshot algorithm) at 48 weeks, in each arm

  48 weeks

• 1.3.2 Number of patients with HIV-1 virologic suppression at 48 weeks, in the combined DTG/3TC arms (Arm 1 + Arm 2)

  48 weeks

• 1.3.3 Change from baseline in CD4 over 28 weeks and 48 weeks of HIV treatment, by arm

  28 weeks, 48 weeks

• 1.3.4 Proportion of participants with DTG Cmin above target DTG trough of 158 ng/mL

  2years

• 1.3.4 Concentration of the PK of DTG

  2years

Study Arms (3)

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

Drug: Dolutegravir 50mg Tab; Drug: Dolutegravir/Lamivudine 50 MG-300mg Oral Tablet [DOVATO]

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

ACTIVE COMPARATOR

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

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

Interventions

Dolutegravir 50mg Tab DRUG

Participants will receive Dolutegravir 50mg

Also known as: TIVICAY 50 mg, TIVICAY PD

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

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

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

Arm 1: DTG 50 mg/ 3TC 300mg (Dovato®) twice daily (BID); Arm 2: DTG 50 mg/ 3TC 300mg (Dovato®) once daily (QD) in the morning with DTG 50 mg in the evening

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

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

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

Eligibility Criteria

• Age: 15 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant, or plans to become pregnant.

Sponsors & Collaborators

• Johns Hopkins University: lead
• ViiV Healthcare: collaborator

Study Sites (6)

Instituto Tropical de Doenças Infecciosas Manaus

Manaus, Amazonas, 69040-000, Brazil

RECRUITING

Universidade Federal da Bahia

Salvador, Estado de Bahia, 40110-160, Brazil

RECRUITING

FIOCruz

Rio de Janeiro, Rio de Janeiro, 21040-360, Brazil

RECRUITING

Hospital Geral de Nova Iguaçu

Rio de Janeiro, Rio de Janeiro, 26210-190, Brazil

RECRUITING

CePClin - Center for Studies and Research in Infectious Diseases Ltda

Natal, Rio Grande do Norte, 59.025-050, Brazil

RECRUITING

RDSS- Ricardo Diaz Solucoes Cientificas

São Paulo, São Paulo, 04037-030, Brazil

RECRUITING

MeSH Terms

Conditions

Tuberculosis

Interventions

dolutegravir; Lamivudine; Tenofovir

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ethel M Weld, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beatriz M Kohler, RN

CONTACT

410 614 3812; bkohler@jhmi.edu

Kate Boehner, RN

CONTACT

kboehne1@jh.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Arm 1(n=50): DTG 50mg/3TC 300 mg FDC tablet (Dovato®) twice daily during TB therapy and for 2 weeks after, then Dolutegravir (DTG) 50mg / lamivudine (3TC) 300 mg fixed dose combination (FDC) tablet (Dovato®) once daily to week 52 Arm 2(n=50): 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 Arm 3(n=50): 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 Dolutegravir (DTG) 50 mg + Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC) FDC tablet once daily to week 52

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 11, 2024
• Study Start: September 18, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

BR (6)