Immediate Versus Deferred Start of Anti-HIV Therapy in HIV-Infected Adults Being Treated for Tuberculosis
Condition: HIV Infection; Tuberculosis
MeSH terms: Tuberculosis
Intervention: Strategy: Immediate ART; Strategy: Deferred ART
Intervention description: The intervention is the strategy of initiating antiretroviral therapy (ART) after approximately 2 weeks of rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided ART is efavirenz (EFV) 600 mg (1 tablet orally), emtricitabine (FTC) 200 mg (1 capsule orally), and tenofovir disoproxil fumarate (TDF) 300 mg (1 tablet orally) daily. Substitutions with other locally available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals that are compatible with TB treatment may be used at the discretion of the site investigator. The TB treatment will be supplied and monitored by the host country TB control program.; The intervention is the strategy of initiating ART either after 8-12 weeks of RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided ART is EFV 600 mg (1 tablet orally), FTC 200 mg (1 capsule orally), and TDF 300 mg (1 tablet orally) daily. Initiation outside of these windows, on a case by case basis, is permitted at the discretion of the site investigator. Substitutions with other locally available U.S. FDA-approved or tentatively approved antiretrovirals that are compatible with TB treatment may be used at the discretion of the site investigator. The TB treatment will be supplied and monitored by the host country TB control program.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 809.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No
Keywords: Treatment Naive; TB; HIV; Antiretroviral Agents; Strategy Study

Summary:

      The purpose of this study is to determine the best time to begin anti-HIV treatment in
      individuals who have HIV and tuberculosis (TB).

      Study hypothesis: Immediate antiretroviral therapy (ART), initiated after approximately 2
      weeks of TB treatment, will reduce the frequency of other AIDS-defining illnesses and death
      in HIV-infected participants being treated for TB by at least 40% at week 48 when compared to
      deferred ART, initiated at after 8-12 weeks of TB treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-infected.

          -  Confirmed or probable TB (more information on the criterion can be found in the
             protocol).

          -  Chest x-ray within 30 days prior to study entry.

          -  Receipt of 1-14 cumulative days of rifampin- or other rifamycin-based TB treatment
             that was initiated within 28 days prior to study entry.

          -  CD4 count less than 250 cells/mm^3 within 30 days prior to study entry.

          -  Willing to use acceptable methods of contraception while on study drugs and for 6
             weeks after stopping these drugs.

          -  Able to swallow oral medications.

          -  Parent of guardian willing to provide informed consent, if applicable.

          -  Karnofsky performance score =>20 at time of study entry.

        Exclusion Criteria:

          -  ART for longer than 7 cumulative days prior to study entry or treatment for any period
             of time with one or more antiretrovirals. Participants who have taken ART during
             pregnancy or for occupational exposure are not excluded.

          -  Allergy or sensitivity to any of the study drugs or their formulations.

          -  History of multidrug-resistant TB.

          -  Receipt of any investigational therapy or chemotherapy within 30 days prior to study
             entry.

          -  Certain medications.

          -  Breastfeeding.