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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

November 18, 2006
January 9, 2007
January 1994
Not Provided
  • Development of Tuberculosis
  • Suspension of chemoprophylaxis due to adverse effects
Same as current
Complete list of historical versions of study NCT00402454 on ClinicalTrials.gov Archive Site
  • Suspension of chemoprophylaxis due tovoluntary withdrawal
  • Mortality.
Same as current
Not Provided
Not Provided
 
Evaluation of Three Regimens of Chemoprophylaxis for Tuberculosis in Patients co-Infected by HIV and Mycobacterium Tuberculosis
Evaluation of Three Regimens of Chemoprophylaxis for Tuberculosis in Patients co-Infected by HIV and Mycobacterium Tuberculosis

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

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 Twenty-seven percent of the patients voluntarily abandoned chemoprophylaxis and 9.7% were withdrawn due to adverse side-effects.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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
Drug: isoniazid, rifampin + isoniazid or rifampin + pyrazinamide
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
December 1998
Not Provided

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00402454
GAEI 94/0071B, FIS 94/0071B
Not Provided
Not Provided
Sociedad Andaluza de Enfermedades Infecciosas
Not Provided
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
Sociedad Andaluza de Enfermedades Infecciosas
November 2006

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