At a glance
ClinicalIndex Comparison Record- ✓HIV-infected persons
- ✓Confirmed or probable tuberculosis
- ✓CD4 count less than 250 cells/mm³ within 30 days of study entry
- ✓Early stage of TB treatment (1-14 cumulative days of rifampin- or rifamycin-based therapy initiated within 28 days)
- ✕Prior antiretroviral therapy (ART) for more than 7 cumulative days, except for occupational exposure or perinatal/pregnancy use
- ✕History of multidrug-resistant tuberculosis
- ✕Allergy or sensitivity to study drugs or their formulations
- ✕Investigational therapy or chemotherapy within 30 days prior to study entry
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Strategy Study of Immediate Versus Deferred Initiation of Antiretroviral Therapy for AIDS Disease-Free Survival in HIV-Infected Persons Treated for Tuberculosis With CD4 Less Than 250 Cells/mm^3
In Brief
A Phase 4 clinical trial evaluating Strategy: Immediate ART and Strategy: Deferred ART for HIV Infection and Tuberculosis. Completed, enrolled 809 participants across 26 sites in 13 countries.
Detailed 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.
Study Details
Timeline
Interventions
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.