Dolutegravir/Lamivudine Dual Therapy for ART-naïve People With HIV and TB Receiving Rifampin-based TB Treatment
NCT Number: NCT06497465
Acronym: DOVETAIL
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Tuberculosis|HIV
Interventions: DRUG: Dolutegravir 50mg Tab|DRUG: Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO]|DRUG: Dolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC)
Sponsor: Johns Hopkins University
Collaborators: ViiV Healthcare
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01-31
Completion Date: 2029-01-31
Locations: Instituto Tropical de Doenças Infecciosas Manaus, Manaus, AM, 69040-000, Brazil|Universidade Federal da Bahia, Salvador, BA, 40110-160, Brazil|FIOCruz, Rio De Janeiro, RJ, 21040-360, Brazil|Hospital Geral de Nova Iguaçu, Rio De Janeiro, RJ, 26210-190, Brazil|Universidade Federal do Rio Grande do Norte, Natal, RN, 59037-170, Brazil|Fundação Universidade de Caxias do Sul, Caxias Do Sul, RS, Brazil|Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, 90035-903, Brazil|Faculdade de Medicina de Botucatu/Unesp, Botucatu, SP, 18618-687, Brazil

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

Primary Outcome Measures: 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 Outcome Measures: 1.3.1 Number of patients with HIV-1 virologic suppression (via FDA snapshot algorithm) at 48 weeks, in each arm, To compare the proportion in each arm above DTG protein adjusted 90% inhibitory concentration (IC90) (64 ng/mL) at each PK sampling., 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), To compare the proportion 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, To compare the changes from baseline over 28 weeks and 48 weeks of HIV treatment by the arm., 28 weeks, 48 weeks|1.3.4 Proportion of participants with DTG Cmin above target DTG trough of 158 ng/mL, 1-To estimate the pharmacokinetics (PK) of DTG when given twice daily as a 50 mg/ 300 mg DTG/3TC FDC with rifampicin (RIF)-containing TB treatment, X DTG 50 mg/ 3TC 300 mg FDC given once daily without RIF among the same participants after completing TB treatment., 2years|1.3.4 Concentration of the PK of DTG, Concentration of DTG when given twice daily as a 50 mg/ 300 mg DTG/3TC FDC with RIF-containing TB treatment, X DTG 50 mg/ 3TC 300 mg FDC given once daily without RIF among the same participants after completing TB treatment., 2years|1.3.5 Compare Grade 3 or 4 adverse events, by arm, To compare the Grade 3 \& 4 adverse events by arm, 2 years