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

National Institute of Respiratory Diseases (INER)

Status: Terminated

Conditions: AIDS; Tuberculosis; HIV

Treatments: Drug: Deferred RV and antiMTB treatment; Drug: Simultaneous ARV and antiMTB

Study type: Interventional

Funder types: Other

Identifiers

NCT00737724

C43-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 2 patient groups

Group 1

Experimental group

Description:

Receives both, simultaneously antiretroviral therapy and antituberculosis therapy

Treatment:

Drug: Simultaneous ARV and antiMTB

Group 2

Experimental group

Description:

Receives only antituberculosis therapy, and 2 months afterwards antiretroviral therapy

Treatment:

Drug: Deferred RV and antiMTB treatment