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

Information source: Sociedad Andaluza de Enfermedades Infecciosas
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: isoniazid, rifampin + isoniazid or rifampin + pyrazinamide (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sociedad Andaluza de Enfermedades Infecciosas

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

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

Development of Tuberculosis

Suspension of chemoprophylaxis due to adverse effects

Secondary outcome:

Suspension of chemoprophylaxis due tovoluntary withdrawal

Mortality.

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Hospital Universitario Reina Sofía, Córdoba 14002, Spain
Additional Information

Starting date: January 1994
Last updated: January 9, 2007

Page last updated: August 23, 2015

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