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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Instituto Nacional de Enfermedades Respiratorias.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Consorcio de Investigación sobre VIH/SIDA/TB (CISIDAT).
Information provided by:
Instituto Nacional de Enfermedades Respiratorias
ClinicalTrials.gov Identifier:
NCT00737724
First received: August 19, 2008
Last updated: June 15, 2011
Last verified: August 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: Yes ]
  • Time to negative measurement of mycobacterial load in body fluids or affected tissues [ Time Frame: 24 wk ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CD4+ cell count increase [ Time Frame: 24 wk ] [ Designated as safety issue: No ]
  • Lymphoproliferative response to specific antigens against Mtb [ Time Frame: 24 wk ] [ Designated as safety issue: No ]
  • Time to undetectable HIV plasma load; HIV genotype [ Time Frame: 24 wk ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: March 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737724

Contacts
Contact: Gustavo Reyes-Terán, MD (+52 55) 56667985 reyesteran@cieni.org.mx
Contact: Akio Murakami, MD (+52 55) 56667985 akio.murakami@cieni.org.mx

Locations
Mexico
Centro de Investigaciones en Enfermedades Infecciosas Recruiting
Mexico city, DF, Mexico, 14080
Principal Investigator: Gustavo Reyes-Terán, MD         
Sub-Investigator: Karla Romero, MD         
Sub-Investigator: Ricardo Vega-Barrientos, MD         
Sub-Investigator: Christopher E Ormsby, MSc         
Sub-Investigator: Akio Murakami, MD         
Hospital Civil de Guadalajara Fray Antonio Alcalde Active, not recruiting
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: Dr. Gustavo Reyes Terán, MD, Instituto Nacional de Enfermedades Respiratorias
ClinicalTrials.gov Identifier: NCT00737724     History of Changes
Other Study ID Numbers: C43-06
Study First Received: August 19, 2008
Last Updated: June 15, 2011
Health Authority: Mexico: Ethics Committee

Keywords provided by Instituto Nacional de Enfermedades Respiratorias:
ELISPOT
Deferred treatment
Immune Recovery Inflammatory Syndrome

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Efavirenz
Isoniazid
Antitubercular Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-Bacterial Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents

ClinicalTrials.gov processed this record on October 02, 2014