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

This study has been completed.
Sponsor:
Information provided by:
Sociedad Andaluza de Enfermedades Infecciosas
ClinicalTrials.gov Identifier:
NCT00402610
First received: November 18, 2006
Last updated: October 23, 2008
Last verified: November 2006

November 18, 2006
October 23, 2008
January 1994
Not Provided
Development of tuberculosis
Same as current
Complete list of historical versions of study NCT00402610 on ClinicalTrials.gov Archive Site
  • Suspension of chemoprophylaxis due to adverse effects
  • Mortality
Same as current
Not Provided
Not Provided
 
A Randomized Trial of Three Regimens to Prevent Tuberculosis in HIV-Infected Patients With Anergy
A Randomized Trial of Three Regimens to Prevent Tuberculosis in HIV-Infected Patients With Anergy

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV Infections
  • Tuberculosis
Drug: isoniazid, rifampin + isoniazid, rifampin + pyrazinamide or not treatment
Not Provided
Rivero A, Lopez-Cortes L, Castillo R, Lozano F, Garcia MA, Diez F, Escribano JC, Canueto J, Pasquau J, Hernandez JJ, Polo R, Martinez-Marcos FJ, Kindelan JM, Rey R; Grupo Andaluz para el estudio de las Enfermedades Infecciosas (GAEI). [Randomized trial of three regimens to prevent tuberculosis in HIV-infected patients with anergy] Enferm Infecc Microbiol Clin. 2003 Jun-Jul;21(6):287-92. Spanish.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
332
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
  • 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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00402610
GAEI 94/0071a, FIS 94/0071A
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