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

NCT ID: NCT00402610

Last Updated: 2008-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

332 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-01-31

Study Completion Date

1998-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections Tuberculosis

Keywords

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HIV Tuberculosis Chemoprophylaxis Anergy AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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isoniazid, rifampin + isoniazid, rifampin + pyrazinamide or not treatment

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sociedad Andaluza de Enfermedades Infecciosas

NETWORK

Sponsor Role lead

Principal Investigators

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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

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Hospital Universitario Reina Sofía

Córdoba, , Spain

Site Status

Countries

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Spain

References

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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. doi: 10.1016/s0213-005x(03)72942-5. Spanish.

Reference Type RESULT
PMID: 12809582 (View on PubMed)

Other Identifiers

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FIS 94/0071A

Identifier Type: -

Identifier Source: secondary_id

GAEI 94/0071a

Identifier Type: -

Identifier Source: org_study_id