Simultaneous Versus Sequential Antiretroviral Therapy (ARV) Therapy and Mycobacterium Tuberculosis (MTB) Treatment

Not Applicable

Terminated

• Conditions: AIDS; HIV; Tuberculosis
• Interventions: Drug: Simultaneous ARV and antiMTB; Drug: Deferred RV and antiMTB treatment

• Registration Number: NCT00737724
• Lead Sponsor: Instituto Nacional de Enfermedades Respiratorias

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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-08-19
• Study First Submitted QC: 2008-08-19
• Study First Posted: 2008-08-20
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Simultaneous ARV and antiMTB	Receives both, simultaneously antiretroviral therapy and antituberculosis therapy
Group 2	Deferred RV and antiMTB treatment	Receives only antituberculosis therapy, and 2 months afterwards antiretroviral therapy

Primary Outcome Measures

Name	Time	Method
Time to remission of signs and symptoms of active tuberculosis as well as general symptoms.	96 wk
Time to negative measurement of mycobacterial load in body fluids or affected tissues	24 wk

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Centro de Investigaciones en Enfermedades Infecciosas; 🇲🇽 Mexico city, DF, Mexico

Hospital Civil de Guadalajara Fray Antonio Alcalde; 🇲🇽 Guadalajara, Jalisco, Mexico