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Evaluation of Three Regimens of Chemoprophylaxis for Tuberculosis in Patients co-Infected by HIV and Mycobacterium Tuberculosis

This study has been completed.
Sponsor:
Information provided by:
Sociedad Andaluza de Enfermedades Infecciosas
ClinicalTrials.gov Identifier:
NCT00402454
First received: November 18, 2006
Last updated: January 9, 2007
Last verified: November 2006
History of Changes
  Purpose

To evaluate adherence and safety of three regimens of chemoprophylaxis for tuberculosis (TB) in HIV-infected patients with positive tuberculin skin test.


Condition Intervention Phase
HIV Infections
 Drug: isoniazid, rifampin + isoniazid or rifampin + pyrazinamide
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of Three Regimens of Chemoprophylaxis for Tuberculosis in Patients co-Infected by HIV and Mycobacterium Tuberculosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sociedad Andaluza de Enfermedades Infecciosas:

Primary Outcome Measures:
  • Development of Tuberculosis
  • Suspension of chemoprophylaxis due to adverse effects

Secondary Outcome Measures:
  • Suspension of chemoprophylaxis due tovoluntary withdrawal
  • Mortality.

Estimated Enrollment: 300
Study Start Date: January 1994
Estimated Study Completion Date: December 1998
Detailed Description:

DESINGS: We performed a randomised, comparative and open clinical assay carried out in 316 HIV-infected patients. The patients were randomly assigned to one of three regimens, 108 to isoniazid for six months (6H), 103 to rifampin and isoniazid for three months (3RH), and 105 to pyrazinamide and rifampin for two months (2RZ).

RESULTS: The TB rates (cases per 100 persons/year) in the three treatment groups were 3.4 in 6H, 4.5 in 3RH and 1.9 in 2RZ. The relative risk for TB with 6H as compared with 2RZ was 1.76, and with 3RH, 2.34. Twenty-seven percent of the patients voluntarily abandoned chemoprophylaxis and 9.7% were withdrawn due to adverse side-effects. Seven patients were withdraw due to hepatotoxicity (5 in 6H, 2 in 3RH and 0 in 2RZ). No appreciable differences were found among the three regimens.

CONCLUSION: In our study the 2RZ regimen was as safe as the 6H and 3RH regimens. We have nor observed a higher incidence of hepatotoxicity in patients who received 2RZ.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV infection confirmed by ELISA and Western blot
  • Age between 18 and 65 years
  • Life expectancy greater than two years
  • Reactivity to PPD > 5 mm

Exclusion Criteria:

  • Presence of active tuberculosis
  • Background of previous antituberculosis therapy or chemoprophylaxis
  • Presence of symptoms or signs suggesting pulmonary or extra-pulmonary tuberculosis
  • History of hypersensitivity to the drugs used in the study (isoniazid, rifampin or pyrazinamide)
  • Aspartate-aminotransferase and/or alanine-aminotransferase plasma concentrations more than or equal to four times their normal values, total bilirubin more than 2 mg/ml, and/or creatinine more than 2 mg/ml
  • Pregnancy
  • Undergoing treatment incompatible with any of the drugs used in the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00402454

Locations
Spain
Hospital Universitario Reina Sofía
Córdoba, Spain, 14002
Sponsors and Collaborators
Sociedad Andaluza de Enfermedades Infecciosas
Investigators
Study Chair: Antonio Rivero, MD PhD Hospital Universitario Reina Sofía, Córdoba, Spain
Principal Investigator: Luis Lopez-Crtés, MD, PhD Hospital Universitario Virgen del Rocío, Sevilla, Spain
Principal Investigator: Rafael Castillo, MD 3 Sección de Enfermedades Infecciosas. Hospital Clínico Universitario San Cecilio. Avda. Dr. Oloriz 16. 18012 Granada
Principal Investigator: José Verdejo, MD Servicio de Enfermedades Infecciosas. Hospital Carlos III. Sinesio Delgado 10. 28029 Madrid
Principal Investigator: Miguel Angel García, MD Sección de Enfermedades Infecciosas. Hospital Carlos Haya. Avda. Carlos Haya s/n. 29010 Málaga.
Principal Investigator: Felipes Diez, MD Servicio de Medicina Interna. Hospital Torrecárdenas. Paraje de Torrecárdenas s/n. 04009 Almería.
Principal Investigator: Jose Carlos Escribano, MD Sección de Enfermedades Infecciosas. Hospital Universitario Puerta del Mar. Avda. Ana de Viya, 21. 11009 Cádiz. Spain
Principal Investigator: Jesús Canueto, MD Sección de Enfermedades Infecciosas. Hospital Punta Europa de Algeciras. Ctra de Getares s/n. 11207 Algeciras (Cádiz)., Spain
Principal Investigator: Manuel Marquez, MD Unidad de Enfermedades Infecciosas. Hospital Universitario Virgen de la Victoria, Campus Universitario Teatinos s/n. 29010 Málaga.
Principal Investigator: Juan Jose Hernandez, MD Unidad de Enfermedades Infecciosas. Hospital Ciudad de Jaén, Avda del Ejército Español, 10. 23007 Jaén, Spain.
Principal Investigator: Juan Pasquau, MD Sección de Enfermedades Infecciosas. Hospital Universitario Virgen de las Nieves. Avda de las Fuerzas Armadas, 2. 18014 Granada, Spain.
Principal Investigator: Fernando Lozano, MD PhD Sección de Enfermedades Infecciosas. Hospital Universitario Virgen de Valme. Ctra. de Cádiz s/n. 41012 Sevilla, Spain
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00402454     History of Changes
Other Study ID Numbers: GAEI 94/0071B, FIS 94/0071B
Study First Received: November 18, 2006
Last Updated: January 9, 2007
Health Authority: Spain: Ministry of Health

Keywords provided by Sociedad Andaluza de Enfermedades Infecciosas:
HIV
Tuberculosis
Prophylaxis
AIDS

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Mycobacterium Infections
Tuberculosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
 Bacterial Infections
Isoniazid
Pyrazinamide
Rifampin
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Lipid Regulating Agents
Antibiotics, Antitubercular

ClinicalTrials.gov processed this record on March 03, 2013