Efficacy of Simultaneous Versus Sequential Antiretroviral Therapy and Antituberculosis Treatment in Patients With AIDS and Active Tuberculosis. Open, Randomized and Controlled, Multisite Clinical Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Simultaneous ARV and antiMTB
- Conditions
- HIV
- Sponsor
- Instituto Nacional de Enfermedades Respiratorias
- Enrollment
- 63
- Locations
- 2
- Primary Endpoint
- Time to remission of signs and symptoms of active tuberculosis as well as general symptoms.
- Status
- Terminated
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of this study is to evaluate and compare the efficacy of immediate antiretroviral therapy versus 2 month deferred anti-Tb therapy upon the clinical course of tuberculosis and HIV infection in patients with AIDS and active tuberculosis.
Detailed Description
AIDS and tuberculosis are two international and national priority public health problems. The best time for starting antiretroviral therapy in patients with AIDS and active tuberculosis is not clear, despite of the guidelines regarding CD4+ count. The debate surrounding this issue is mainly due to the difficulty among adherence of anti-MTb and anti-HIV treatment, the pharmacological interaction, the adverse events related to drugs and the risk of inflammatory reconstitution syndrome, especially in patients with advanced HIV infection. Moreover, there is great debate upon the lack of knowledge of the degree of immune reconstitution throughout time against Mtb induced by the anti-HIV therapy.
Investigators
Gustavo Reyes-Teran
Principal Investigator
Instituto Nacional de Enfermedades Respiratorias
Eligibility Criteria
Inclusion Criteria
- •HIV infected
- •\< 200 CD4+ cells/mL
- •Active pulmonary tuberculosis (with or without extrapulmonary involvement)
Exclusion Criteria
- •Meningeal tuberculosis
- •Unable to attend 96 wk follow-up
Arms & Interventions
Group 1
Receives both, simultaneously antiretroviral therapy and antituberculosis therapy
Intervention: Simultaneous ARV and antiMTB
Group 2
Receives only antituberculosis therapy, and 2 months afterwards antiretroviral therapy
Intervention: Deferred RV and antiMTB treatment
Outcomes
Primary Outcomes
Time to remission of signs and symptoms of active tuberculosis as well as general symptoms.
Time Frame: 96 wk
Time to negative measurement of mycobacterial load in body fluids or affected tissues
Time Frame: 24 wk
Secondary Outcomes
- CD4+ cell count increase(24 wk)
- Lymphoproliferative response to specific antigens against Mtb(24 wk)
- Time to undetectable HIV plasma load; HIV genotype(24 wk)