Trial record 15 of 34 for: " August 13, 2008":" September 12, 2008"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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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

History of Changes

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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS Tuberculosis

Drug Information available for: Isoniazid Efavirenz Truvada

U.S. FDA Resources

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

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:

Website of the sponsoring center This link exits the ClinicalTrials.gov site

Consortium for HIV/TB Research in Mexico This link exits the ClinicalTrials.gov site

Publications:

Raviglione MC, Narain JP, Kochi A. HIV-associated tuberculosis in developing countries: clinical features, diagnosis, and treatment. Bull World Health Organ. 1992;70(4):515-26. Review.

De Cock KM, Soro B, Coulibaly IM, Lucas SB. Tuberculosis and HIV infection in sub-Saharan Africa. JAMA. 1992 Sep 23-30;268(12):1581-7. Review.

Whalen C, Horsburgh CR, Hom D, Lahart C, Simberkoff M, Ellner J. Accelerated course of human immunodeficiency virus infection after tuberculosis. Am J Respir Crit Care Med. 1995 Jan;151(1):129-35.

Goletti D, Weissman D, Jackson RW, Graham NM, Vlahov D, Klein RS, Munsiff SS, Ortona L, Cauda R, Fauci AS. Effect of Mycobacterium tuberculosis on HIV replication. Role of immune activation. J Immunol. 1996 Aug 1;157(3):1271-8.

Chaisson RE, Clermont HC, Holt EA, Cantave M, Johnson MP, Atkinson J, Davis H, Boulos R, Quinn TC, Halsey NA. Six-month supervised intermittent tuberculosis therapy in Haitian patients with and without HIV infection. Am J Respir Crit Care Med. 1996 Oct;154(4 Pt 1):1034-8.

Small PM, Schecter GF, Goodman PC, Sande MA, Chaisson RE, Hopewell PC. Treatment of tuberculosis in patients with advanced human immunodeficiency virus infection. N Engl J Med. 1991 Jan 31;324(5):289-94.

Burman WJ, Jones BE. Treatment of HIV-related tuberculosis in the era of effective antiretroviral therapy. Am J Respir Crit Care Med. 2001 Jul 1;164(1):7-12. Review. No abstract available.

Dean GL, Edwards SG, Ives NJ, Matthews G, Fox EF, Navaratne L, Fisher M, Taylor GP, Miller R, Taylor CB, de Ruiter A, Pozniak AL. Treatment of tuberculosis in HIV-infected persons in the era of highly active antiretroviral therapy. AIDS. 2002 Jan 4;16(1):75-83.

Narita M, Ashkin D, Hollender ES, Pitchenik AE. Paradoxical worsening of tuberculosis following antiretroviral therapy in patients with AIDS. Am J Respir Crit Care Med. 1998 Jul;158(1):157-61.

Lawn SD, Bekker LG, Wood R. How effectively does HAART restore immune responses to Mycobacterium tuberculosis? Implications for tuberculosis control. AIDS. 2005 Jul 22;19(11):1113-24.

de Jong BC, Israelski DM, Corbett EL, Small PM. Clinical management of tuberculosis in the context of HIV infection. Annu Rev Med. 2004;55:283-301.

Orlovic D, Smego RA Jr. Paradoxical tuberculous reactions in HIV-infected patients. Int J Tuberc Lung Dis. 2001 Apr;5(4):370-5. Review.

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:

Acquired Immunodeficiency Syndrome
HIV Infections
Tuberculosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections

Bacterial Infections
Antitubercular Agents
Isoniazid
Efavirenz
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013

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