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A Randomized Trial of Three Regimens to Prevent Tuberculosis in HIV-Infected Patients With Anergy

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; Tuberculosis

Intervention: isoniazid, rifampin + isoniazid, rifampin + pyrazinamide or not treatment (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

INTRODUCTION. To evaluate the efficacy of three regimens of prophylactic therapy for tuberculosis in HIV-infected patients with anergy. METHODS. Prospective, multi-center, randomized, comparative, and open clinical trial. Anergy was defined as absence of induration in response to three antigens (PPD, Candida albicans and parotiditis antigen) applied by the Mantoux method. Patients were randomized into one of the following prophylactic treatment groups: isoniazid for six months (6H), rifampin plus isoniazid for three months (3RH), rifampin plus pyrazinamide for two months (2RZ) or no treatment (NT). After completion of treatment, patients were followed up for two years.

Clinical Details

Official title: A Randomized Trial of Three Regimens to Prevent Tuberculosis in HIV-Infected Patients With Anergy

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

Primary outcome: Development of tuberculosis

Secondary outcome:

Suspension of chemoprophylaxis due to adverse effects

Mortality

Detailed description: This study is a controlled, open, randomized, multi-center clinical trial. The study was authorized by the Clinical Research Ethics Committee of all participating centers and informed written consent was obtained from all the patients included. The cutaneous anergy was defined by the absence of a reaction (0 mm) to skin reactivity tests with tuberculin, Candida albicans, and parotiditis antigens 72 hours after inoculation. The patients were randomzed into one of the following four groups: isoniazid for 6 months (6H), rifampin plus isoniazid for 3 months (3RH), rifampin plus pyrazinamide for 2 months (2RZ) or no treatment (NT). All of the participating subjects underwent a basal study that included clinical and epidemiological history, chest x-ray, hemogram, analysis of serum creatinine concentrations, uric acid, AST, ALT, alkaline phosphatase, and total bilirubin, as well as a CD4+ T-lymphocyte count. During prophylactic treatment, patients were evaluated every 15 days for the first two months and monthly thereafter. At each check-up it was determined whether or not the patient was following the treatment properly and whether there were any adverse effects. Therapeutic completion was defined as taking at least 80% of the total prescribed dosages. Chemoprophylaxis was discontinued whenever a patient requested to do so or for any of the following reasons: appearance of Grade 3 or 4 side effects that could be attributed to the drugs used in the study; increases in AST and/or ALT values of three times or more their basal values; development of TB; or diagnosis of any disease that made interruption of the treatment advisable.

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

- Cutaneous anergy defined by the absence of a reaction (0 mm) to skin reactivity tests

with tuberculin, Candida albicans, and parotiditis antigens 72 hours after inoculation. 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: October 23, 2008

Page last updated: August 23, 2015

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