We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
(Other published trials showed definitive expected superiority of Group 1)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00737724
First Posted: August 20, 2008
Last Update Posted: March 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Consorcio de Investigación sobre VIH/SIDA/TB (CISIDAT).
Information provided by (Responsible Party):
Gustavo Reyes-Teran, Instituto Nacional de Enfermedades Respiratorias
  Purpose
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.

Condition Intervention
HIV AIDS Tuberculosis Drug: Simultaneous ARV and antiMTB Drug: Deferred RV and antiMTB treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: 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.

Resource links provided by NLM:


Further study details as provided by Gustavo Reyes-Teran, Instituto Nacional de Enfermedades Respiratorias:

Primary Outcome Measures:
  • Time to remission of signs and symptoms of active tuberculosis as well as general symptoms. [ Time Frame: 96 wk ]
  • Time to negative measurement of mycobacterial load in body fluids or affected tissues [ Time Frame: 24 wk ]

Secondary Outcome Measures:
  • CD4+ cell count increase [ Time Frame: 24 wk ]
  • Lymphoproliferative response to specific antigens against Mtb [ Time Frame: 24 wk ]
  • Time to undetectable HIV plasma load; HIV genotype [ Time Frame: 24 wk ]

Enrollment: 63
Study Start Date: March 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Receives both, simultaneously antiretroviral therapy and antituberculosis therapy
Drug: Simultaneous ARV and antiMTB
Receives both, simultaneously antiretroviral therapy and antituberculosis therapy
Other Names:
  • HAART
  • isoniazid
  • Efavirenz
  • Truvada
Experimental: Group 2
Receives only antituberculosis therapy, and 2 months afterwards antiretroviral therapy
Drug: Deferred RV and antiMTB treatment
Receives only antituberculosis therapy and 2 months afterwards antiretroviral therapy
Other Names:
  • HAART
  • isoniazid
  • Efavirenz
  • Truvada

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00737724


Locations
Mexico
Centro de Investigaciones en Enfermedades Infecciosas
Mexico city, DF, Mexico, 14080
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico, 45235
Sponsors and Collaborators
Instituto Nacional de Enfermedades Respiratorias
Consorcio de Investigación sobre VIH/SIDA/TB (CISIDAT).
Investigators
Principal Investigator: Gustavo Reyes-Terán, MD Instituto Nacional de Enfermedades Respiratorias
  More Information

Additional Information:
Publications:

Responsible Party: Gustavo Reyes-Teran, Principal Investigator, Instituto Nacional de Enfermedades Respiratorias
ClinicalTrials.gov Identifier: NCT00737724     History of Changes
Other Study ID Numbers: C43-06
First Submitted: August 19, 2008
First Posted: August 20, 2008
Last Update Posted: March 26, 2015
Last Verified: March 2015

Keywords provided by Gustavo Reyes-Teran, Instituto Nacional de Enfermedades Respiratorias:
Enzyme-Linked ImmunoSpot
Deferred treatment
Immune Recovery Inflammatory Syndrome

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Efavirenz
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Isoniazid
Antitubercular Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers
Anti-Bacterial Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Anti-HIV Agents