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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00737724

Enrollment

Registered

2008-08-20

Start date

2008-03-31

Completion date

2011-02-28

Last updated

2015-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIDS, HIV, Tuberculosis

Keywords

Enzyme-Linked ImmunoSpot, Deferred treatment, Immune Recovery Inflammatory Syndrome

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.

Interventions

DRUGSimultaneous ARV and antiMTB

Receives both, simultaneously antiretroviral therapy and antituberculosis therapy

DRUGDeferred RV and antiMTB treatment

Receives only antituberculosis therapy and 2 months afterwards antiretroviral therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026