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| Sponsor: | Sociedad Andaluza de Enfermedades Infecciosas |
|---|---|
| Information provided by: | Sociedad Andaluza de Enfermedades Infecciosas |
| ClinicalTrials.gov Identifier: | NCT00402610 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Tuberculosis |
Drug: isoniazid, rifampin + isoniazid, rifampin + pyrazinamide or not treatment |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized Trial of Three Regimens to Prevent Tuberculosis in HIV-Infected Patients With Anergy |
| Estimated Enrollment: | 332 |
| Study Start Date: | January 1994 |
| Estimated Study Completion Date: | December 1998 |
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | GAEI 94/0071a, FIS 94/0071A |
| Study First Received: | November 18, 2006 |
| Last Updated: | October 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00402610 History of Changes |
| Health Authority: | Spain: Ministry of Health |
|
HIV Tuberculosis Chemoprophylaxis Anergy AIDS |
|
Bacterial Infections Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Anti-Bacterial Agents Rifampin Gram-Positive Bacterial Infections Therapeutic Uses Tuberculosis Retroviridae Infections Nucleic Acid Synthesis Inhibitors Isoniazid |
RNA Virus Infections Immune System Diseases Antilipemic Agents Acquired Immunodeficiency Syndrome Enzyme Inhibitors Pyrazinamide Immunologic Deficiency Syndromes Actinomycetales Infections Pharmacologic Actions Antibiotics, Antitubercular Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Mycobacterium Infections |