A Randomized Trial of Three Regimens to Prevent Tuberculosis in HIV-Infected Patients With Anergy
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ClinicalTrials.gov Identifier: NCT00402610 |
Recruitment Status
:
Completed
First Posted
: November 22, 2006
Last Update Posted
: October 24, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Tuberculosis | Drug: isoniazid, rifampin + isoniazid, rifampin + pyrazinamide or not treatment | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 332 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | A Randomized Trial of Three Regimens to Prevent Tuberculosis in HIV-Infected Patients With Anergy |
Study Start Date : | January 1994 |
Study Completion Date : | December 1998 |
- Development of tuberculosis
- Suspension of chemoprophylaxis due to adverse effects
- Mortality

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00402610
Spain | |
Hospital Universitario Reina Sofía | |
Córdoba, Spain, 14002 |
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 |
Publications of Results:
ClinicalTrials.gov Identifier: | NCT00402610 History of Changes |
Other Study ID Numbers: |
GAEI 94/0071a FIS 94/0071A |
First Posted: | November 22, 2006 Key Record Dates |
Last Update Posted: | October 24, 2008 |
Last Verified: | November 2006 |
Keywords provided by Sociedad Andaluza de Enfermedades Infecciosas:
HIV Tuberculosis Chemoprophylaxis Anergy AIDS |
Additional relevant MeSH terms:
HIV Infections Tuberculosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Rifampin |
Isoniazid Pyrazinamide Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Leprostatic Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP2C8 Inducers Cytochrome P-450 CYP2C19 Inducers Cytochrome P-450 CYP2C9 Inducers |