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

NCT00402610 | Completed Phase 4

• 2 other identifiers: GAEI 94/0071aFIS 94/0071A
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections; Tuberculosis

Keywords

HIV; Tuberculosis; Chemoprophylaxis; Anergy; AIDS

Outcome Measures

Primary Outcomes (1)

• Development of tuberculosis

Secondary Outcomes (2)

• Suspension of chemoprophylaxis due to adverse effects

• Mortality

Interventions

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sociedad Andaluza de Enfermedades Infecciosas: lead

Study Sites (1)

Hospital Universitario Reina Sofía

Córdoba, 14002, Spain

Location

Related Publications (1)

• 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.

  PMID: 12809582 RESULT

MeSH Terms

Conditions

HIV Infections; Tuberculosis; Acquired Immunodeficiency Syndrome

Interventions

Isoniazid; Rifampin; Pyrazinamide

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Pyrazines

Study Officials

• Antonio Rivero, MD PhD

  Hospital Universitario Reina Sofía, Córdoba, Spain

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: November 18, 2006
• First Posted: November 22, 2006
• Study Start: January 1, 1994
• Study Completion: December 1, 1998
• Last Updated: October 24, 2008

Record last verified: 2006-11

Locations

ES (1)