Efficacy and Safety of Concomitant Use of Nevirapine and Rifampicin With HIV-TB

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the efficacy and safety of Nevarapine and Rifampicin vs Efavirenz and Rifampicin in antiretroviral naive patients co-infected with HIV and TB and to investigate whether Rifampicin co-administration in clinical practice leads to a clinically relevant decrease of Nevirapine plasma concentrations in Indian patients co-infected with HIV and Tuberculosis and to characterize drug-associated toxicities (especially hepatic).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: All India Institute of Medical Sciences, New Delhi
• Collaborator: National AIDS Control Organisation
• Treatments: Efavirenz; Nevirapine; Rifampin

Criteria

Inclusion Criteria:

1. HIV infection, documented by ELISA test

2. Adult patients

3. Patients co-infected with HIV and Tuberculosis

4. Concomitant use of Nevirapine and Rifampicin in patients co-infected with HIV and Tuberculosis

5. ART Naïve patients

Exclusion Criteria:

1. Allergy/hypersensitivity to any study drug(s).

2. Prior history of documented drug-resistant TB.

3. Pregnancy

4. Patients with alanine aminotransferase or aspartate aminotransferase levels more than five times the upper limit of normal.

5. Chronic liver disease due to cirrhosis of liver, hepatitis B & C virus infection.

6. Chronic alcoholic.

7. Non-complaint patients.

8. Migrant patients.

9. Serious form of pulmonary or extrapulmonary tuberculosis e.g. severe haemoptysis and unconscious patients

10. Concomitant diabetes mellitus.

11. Epilepsy

12. Patients on other immunosuppressive therapy.

13. Malignancy other than Kaposi's Sarcoma requiring therapy.