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

NCT00737724 | Terminated DMC

• 1 other identifier: C43-06
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV; AIDS; Tuberculosis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (2)

Group 1

EXPERIMENTAL

Receives both, simultaneously antiretroviral therapy and antituberculosis therapy

Drug: Simultaneous ARV and antiMTB

Group 2

EXPERIMENTAL

Receives only antituberculosis therapy, and 2 months afterwards antiretroviral therapy

Drug: Deferred RV and antiMTB treatment

Interventions

Simultaneous ARV and antiMTB DRUG

Receives both, simultaneously antiretroviral therapy and antituberculosis therapy

Also known as: HAART, isoniazid, Efavirenz, Truvada

Group 1

Deferred RV and antiMTB treatment DRUG

Receives only antituberculosis therapy and 2 months afterwards antiretroviral therapy

Also known as: HAART, isoniazid, Efavirenz, Truvada

Group 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• HIV infected
• \< 200 CD4+ cells/mL
• Active pulmonary tuberculosis (with or without extrapulmonary involvement)

You may not qualify if:

• Meningeal tuberculosis
• Unable to attend 96 wk follow-up

Sponsors & Collaborators

• Instituto Nacional de Enfermedades Respiratorias: lead
• Consorcio de Investigación sobre VIH/SIDA/TB (CISIDAT).: collaborator

Study Sites (2)

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, 45235, Mexico

Location

Centro de Investigaciones en Enfermedades Infecciosas

Mexico City, Mexico City, 14080, Mexico

Location

Related Publications (12)

• 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.

  PMID: 1394786 BACKGROUND

• 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. doi: 10.1001/jama.268.12.1581.

  PMID: 1518113 BACKGROUND

• 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. doi: 10.1164/ajrccm.151.1.7812542.

  PMID: 7812542 BACKGROUND

• 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.

  PMID: 8757635 BACKGROUND

• 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. doi: 10.1164/ajrccm.154.4.8887603.

  PMID: 8887603 BACKGROUND

• 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. doi: 10.1056/NEJM199101313240503.

  PMID: 1898769 BACKGROUND

• 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. doi: 10.1164/ajrccm.164.1.2101133. No abstract available.

  PMID: 11435232 BACKGROUND

• 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. doi: 10.1097/00002030-200201040-00010.

  PMID: 11741165 BACKGROUND

• 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. doi: 10.1164/ajrccm.158.1.9712001.

  PMID: 9655723 BACKGROUND

• 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. doi: 10.1097/01.aids.0000176211.08581.5a.

  PMID: 15990564 BACKGROUND

• 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. doi: 10.1146/annurev.med.55.091902.103753.

  PMID: 14746522 BACKGROUND

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

  PMID: 11334257 BACKGROUND

Related Links

• Consortium for HIV/TB Research in Mexico

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Tuberculosis

Interventions

Antiretroviral Therapy, Highly Active; Isoniazid; efavirenz; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Drug Therapy, Combination; Drug Therapy; Therapeutics; Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Tenofovir; Organophosphonates; Organophosphorus Compounds; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Gustavo Reyes-Terán, MD

  Instituto Nacional de Enfermedades Respiratorias

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 19, 2008
• First Posted: August 20, 2008
• Study Start: March 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: March 26, 2015

Record last verified: 2015-03

Locations

ME (2)