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

NCT ID: NCT00402454

Last Updated: 2007-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1994-01-31
• Study Completion Date: 1998-12-31

Brief Summary

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

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 Twenty-seven percent of the patients voluntarily abandoned chemoprophylaxis and 9.7% were withdrawn due to adverse side-effects.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

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

isoniazid, rifampin + isoniazid or rifampin + pyrazinamide

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sociedad Andaluza de Enfermedades Infecciosas

NETWORK

Sponsor Role: lead

Principal Investigators

Antonio Rivero, MD PhD

Role: STUDY_CHAIR

Hospital Universitario Reina Sofía, Córdoba, Spain

Luis Lopez-Crtés, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen del Rocío, Sevilla, Spain

Rafael Castillo, MD

Role: PRINCIPAL_INVESTIGATOR

3 Sección de Enfermedades Infecciosas. Hospital Clínico Universitario San Cecilio. Avda. Dr. Oloriz 16. 18012 Granada

José Verdejo, MD

Role: PRINCIPAL_INVESTIGATOR

Servicio de Enfermedades Infecciosas. Hospital Carlos III. Sinesio Delgado 10. 28029 Madrid

Miguel Angel García, MD

Role: PRINCIPAL_INVESTIGATOR

Sección de Enfermedades Infecciosas. Hospital Carlos Haya. Avda. Carlos Haya s/n. 29010 Málaga.

Felipes Diez, MD

Role: PRINCIPAL_INVESTIGATOR

Servicio de Medicina Interna. Hospital Torrecárdenas. Paraje de Torrecárdenas s/n. 04009 Almería.

Jose Carlos Escribano, MD

Role: PRINCIPAL_INVESTIGATOR

Sección de Enfermedades Infecciosas. Hospital Universitario Puerta del Mar. Avda. Ana de Viya, 21. 11009 Cádiz. Spain

Jesús Canueto, MD

Role: PRINCIPAL_INVESTIGATOR

Sección de Enfermedades Infecciosas. Hospital Punta Europa de Algeciras. Ctra de Getares s/n. 11207 Algeciras (Cádiz)., Spain

Manuel Marquez, MD

Role: PRINCIPAL_INVESTIGATOR

Unidad de Enfermedades Infecciosas. Hospital Universitario Virgen de la Victoria, Campus Universitario Teatinos s/n. 29010 Málaga.

Juan Jose Hernandez, MD

Role: PRINCIPAL_INVESTIGATOR

Unidad de Enfermedades Infecciosas. Hospital Ciudad de Jaén, Avda del Ejército Español, 10. 23007 Jaén, Spain.

Juan Pasquau, MD

Role: PRINCIPAL_INVESTIGATOR

Sección de Enfermedades Infecciosas. Hospital Universitario Virgen de las Nieves. Avda de las Fuerzas Armadas, 2. 18014 Granada, Spain.

Fernando Lozano, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Sección de Enfermedades Infecciosas. Hospital Universitario Virgen de Valme. Ctra. de Cádiz s/n. 41012 Sevilla, Spain

Locations

Hospital Universitario Reina Sofía

Córdoba, , Spain

Countries

Spain

Other Identifiers

FIS 94/0071B

Identifier Type: -

Identifier Source: secondary_id

GAEI 94/0071B

Identifier Type: -

Identifier Source: org_study_id