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Studies

Interventional Recruiting Phase 3

NCT06497465 on ClinicalTrials.gov

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

Official title: 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

  • Sponsor: Johns Hopkins Hospital
  • Collaborators: ViiV Healthcare
  • Enrollment: 150 (Estimated)
  • Study start: 2025-09-18 (Actual)
  • Primary completion: 2028-01-31 (Estimated)
  • Study completion: 2029-01-31 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: 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
  • Masking: None
  • PrimaryPurpose: Treatment

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

Intervention / Treatment

  • Drug: Dolutegravir 50mg Tab
  • Drug: Dolutegravir/Lamivudine 50 MG-300mg Oral Tablet [DOVATO]
  • Drug: Dolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC)

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

Countries

Brazil

Locations and Investigators

  • Instituto Tropical de Doenças Infecciosas Manaus, Manaus, Brazil (Recruiting)
    • Marcus Lacerda, MD, PhD
    • Marcelo Cordeiro,,MD, PhD
    • Marcus Lacerda, MD,PhD (Principal Investigator)
  • Universidade Federal da Bahia, Salvador, Brazil (Recruiting)
  • FIOCruz, Rio de Janeiro, Brazil (Recruiting)
    • Valeria Rolla, MD
    • Aline Benjamin, PhD
    • Valeria Rolla, MD (Principal Investigator)
  • Hospital Geral de Nova Iguaçu, Rio de Janeiro, Brazil (Recruiting)
    • Aline Ramalho, MD
    • Aline Ramalho, MD (Principal Investigator)
  • CePClin - Center for Studies and Research in Infectious Diseases Ltda, Natal, Brazil (Recruiting)
    • Mônica Bay B Bay, MD
    • Sibele F Araújo

Study Officials