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

August 19, 2008
June 15, 2011
March 2008
December 2011   (final data collection date for primary outcome measure)
  • 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 ]
  • Evaluation of signs and symptoms of active tuberculosis as well as general symptoms [ Time Frame: 2,4,6,10,12,16,20,24,36,48,60,72,84,96 wk ] [ Designated as safety issue: Yes ]
  • Measurement of mycobacterial load in body fluids or affected tissues [ Time Frame: 2,4,6,8,12,16,20,24 wk ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00737724 on ClinicalTrials.gov Archive Site
  • 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 ]
  • CD4+ cell count [ Time Frame: 2,4,6 8,10,12,16, 24 wk ] [ Designated as safety issue: No ]
  • Lymphoproliferative response to specific antigens against Mtb [ Time Frame: 2,4,6 8,10,12,16, 24 wk ] [ Designated as safety issue: No ]
  • HIV plasma load; HIV genotype [ Time Frame: 4, 8,12,16, 24 wk ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV
  • AIDS
  • Tuberculosis
  • Drug: Simultaneous ARV and antiMTB
    Receives both, simultaneously antiretroviral therapy and antituberculosis therapy
    Other Names:
    • HAART
    • isoniazid
    • Efavirenz
    • Truvada
  • Drug: Deferred RV and antiMTB treatment
    Receives only antituberculosis therapy and 2 months afterwards antiretroviral therapy
    Other Names:
    • HAART
    • isoniazid
    • Efavirenz
    • Truvada
  • Experimental: Group 1
    Receives both, simultaneously antiretroviral therapy and antituberculosis therapy
    Intervention: Drug: Simultaneous ARV and antiMTB
  • Experimental: Group 2
    Receives only antituberculosis therapy, and 2 months afterwards antiretroviral therapy
    Intervention: Drug: Deferred RV and antiMTB treatment

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Gustavo Reyes-Terán, MD (+52 55) 56667985 reyesteran@cieni.org.mx
Contact: Akio Murakami, MD (+52 55) 56667985 akio.murakami@cieni.org.mx
Mexico
 
NCT00737724
C43-06
Yes
Dr. Gustavo Reyes Terán, MD, Instituto Nacional de Enfermedades Respiratorias
Instituto Nacional de Enfermedades Respiratorias
Consorcio de Investigación sobre VIH/SIDA/TB (CISIDAT).
Principal Investigator: Gustavo Reyes-Terán, MD Instituto Nacional de Enfermedades Respiratorias
Instituto Nacional de Enfermedades Respiratorias
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP