Trials / Terminated
TerminatedNCT00737724
Simultaneous Versus Sequential Antiretroviral Therapy (ARV) Therapy and Mycobacterium Tuberculosis (MTB) Treatment
Efficacy of Simultaneous Versus Sequential Antiretroviral Therapy and Antituberculosis Treatment in Patients With AIDS and Active Tuberculosis. Open, Randomized and Controlled, Multisite Clinical Trial.
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 63 (actual)
- Sponsor
- Instituto Nacional de Enfermedades Respiratorias · Other Government
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Simultaneous ARV and antiMTB | Receives both, simultaneously antiretroviral therapy and antituberculosis therapy |
| DRUG | Deferred RV and antiMTB treatment | Receives only antituberculosis therapy and 2 months afterwards antiretroviral therapy |
Timeline
- Start date
- 2008-03-01
- Primary completion
- 2011-02-01
- Completion
- 2011-02-01
- First posted
- 2008-08-20
- Last updated
- 2015-03-26
Locations
2 sites across 1 country: Mexico
Source: ClinicalTrials.gov record NCT00737724. Inclusion in this directory is not an endorsement.