Evaluation of Three Regimens of Chemoprophylaxis for Tuberculosis in Patients co-Infected by HIV and Mycobacterium Tuberculosis - Full Text View

Sponsored by:	Sociedad Andaluza de Enfermedades Infecciosas
Information provided by:	Sociedad Andaluza de Enfermedades Infecciosas
ClinicalTrials.gov Identifier:	NCT00402454

Purpose

To evaluate adherence and safety of three regimens of chemoprophylaxis for tuberculosis (TB) in HIV-infected patients with positive tuberculin skin test.

Condition	Intervention	Phase
HIV Infections	Drug: isoniazid, rifampin + isoniazid or rifampin + pyrazinamide	Phase IV

MedlinePlus related topics: AIDS Tuberculosis

Drug Information available for: Pyrazinamide Isoniazid Rifampin Ftivazide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Three Regimens of Chemoprophylaxis for Tuberculosis in Patients co-Infected by HIV and Mycobacterium Tuberculosis

Further study details as provided by Sociedad Andaluza de Enfermedades Infecciosas:

Primary Outcome Measures:

Development of Tuberculosis
Suspension of chemoprophylaxis due to adverse effects

Secondary Outcome Measures:

Suspension of chemoprophylaxis due tovoluntary withdrawal
Mortality.

Estimated Enrollment:	300
Study Start Date:	January 1994
Estimated Study Completion Date:	December 1998

Detailed Description:

DESINGS: We performed a randomised, comparative and open clinical assay carried out in 316 HIV-infected patients. The patients were randomly assigned to one of three regimens, 108 to isoniazid for six months (6H), 103 to rifampin and isoniazid for three months (3RH), and 105 to pyrazinamide and rifampin for two months (2RZ).

RESULTS: The TB rates (cases per 100 persons/year) in the three treatment groups were 3.4 in 6H, 4.5 in 3RH and 1.9 in 2RZ. The relative risk for TB with 6H as compared with 2RZ was 1.76, and with 3RH, 2.34. Twenty-seven percent of the patients voluntarily abandoned chemoprophylaxis and 9.7% were withdrawn due to adverse side-effects. Seven patients were withdraw due to hepatotoxicity (5 in 6H, 2 in 3RH and 0 in 2RZ). No appreciable differences were found among the three regimens.

CONCLUSION: In our study the 2RZ regimen was as safe as the 6H and 3RH regimens. We have nor observed a higher incidence of hepatotoxicity in patients who received 2RZ.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HIV infection confirmed by ELISA and Western blot
Age between 18 and 65 years
Life expectancy greater than two years
Reactivity to PPD > 5 mm

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402454

Locations

Spain
Hospital Universitario Reina Sofía
Córdoba, Spain, 14002

Sponsors and Collaborators

Sociedad Andaluza de Enfermedades Infecciosas

Investigators

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 94/0071B, FIS 94/0071B
Study First Received:	November 18, 2006
Last Updated:	January 9, 2007
ClinicalTrials.gov Identifier:	NCT00402454
Health Authority:	Spain: Ministry of Health

Keywords provided by Sociedad Andaluza de Enfermedades Infecciosas:

HIV
Tuberculosis
Prophylaxis
AIDS

Study placed in the following topic categories:

Bacterial Infections
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
Pyrazinamide
Immunologic Deficiency Syndromes
Virus Diseases
Rifampin

Gram-Positive Bacterial Infections
HIV Infections
Sexually Transmitted Diseases
Mycobacterium Infections
Tuberculosis
Retroviridae Infections
Isoniazid

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Infection
Actinomycetales Infections

Pharmacologic Actions
Antibiotics, Antitubercular
Anti-Bacterial Agents
Therapeutic Uses
Lentivirus Infections
Antitubercular Agents
Nucleic Acid Synthesis Inhibitors
Fatty Acid Synthesis Inhibitors
Leprostatic Agents

ClinicalTrials.gov processed this record on January 14, 2009