Back to results

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

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

isoniazid, rifampin + isoniazid or rifampin + pyrazinamide

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV, Tuberculosis, Prophylaxis, AIDS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital Universitario Reina Sofía

Outcomes

Primary Outcome Measures

Development of Tuberculosis

Suspension of chemoprophylaxis due to adverse effects

Secondary Outcome Measures

Suspension of chemoprophylaxis due tovoluntary withdrawal

Mortality.

Full Information

NCT ID

NCT00402454

First Posted

November 18, 2006

Last Updated

January 9, 2007

Sponsor

Sociedad Andaluza de Enfermedades Infecciosas

1. Study Identification

Unique Protocol Identification Number

NCT00402454

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2006

Overall Recruitment Status

Completed

Study Start Date

January 1994 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 1998 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Sociedad Andaluza de Enfermedades Infecciosas

4. Oversight

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

HIV, Tuberculosis, Prophylaxis, AIDS

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

isoniazid, rifampin + isoniazid or rifampin + pyrazinamide

Primary Outcome Measure Information:

Title

Development of Tuberculosis

Title

Suspension of chemoprophylaxis due to adverse effects

Secondary Outcome Measure Information:

Title

Suspension of chemoprophylaxis due tovoluntary withdrawal

Title

Mortality.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials: