Clinical trial NCT00737724: Simultaneous Versus Sequential Antiretroviral Therapy (ARV) Therapy and Mycobacterium Tuberculosis (MTB) Treatment
Official title: Efficacy of Simultaneous Versus Sequential Antiretroviral Therapy and Antituberculosis Treatment in Patients With AIDS and Active Tuberculosis. Open, Randomized and Controlled, Multisite Clinical Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: HIV
AIDS
Tuberculosis
Keywords: Enzyme-Linked ImmunoSpot
Deferred treatment
Immune Recovery Inflammatory Syndrome
Lead sponsor: Instituto Nacional de Enfermedades Respiratorias
Sponsor class: OTHER_GOV
Collaborators: name: Consorcio de Investigación sobre VIH/SIDA/TB (CISIDAT).
First posted: 2008-08-20
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to remission of signs and symptoms of active tuberculosis as well as general symptoms.
timeFrame: 96 wk
measure: Time to negative measurement of mycobacterial load in body fluids or affected tissues
timeFrame: 24 wk
Secondary outcomes:
measure: CD4+ cell count increase
timeFrame: 24 wk
measure: Lymphoproliferative response to specific antigens against Mtb
timeFrame: 24 wk
measure: Time to undetectable HIV plasma load; HIV genotype
timeFrame: 24 wk
Other outcomes:
Locations:
city: Mexico city
country: Mexico
facility: Centro de Investigaciones en Enfermedades Infecciosas
state: DF
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara Fray Antonio Alcalde
state: Jalisco
Study officials:
affiliation: Instituto Nacional de Enfermedades Respiratorias
name: Gustavo Reyes-Terán, MD
role: PRINCIPAL_INVESTIGATOR
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