Status:
COMPLETED
Efficacy and Safety of Concomitant Use of Nevirapine and Rifampicin With HIV-TB
Lead Sponsor:
All India Institute of Medical Sciences
Collaborating Sponsors:
National AIDS Control Organisation
Conditions:
HIV/TB Co-infection
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief 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...
Detailed Description
Drug interactions complicate concurrent treatment of HIV and Mycobacterium tuberculosis co-infection. Drug therapy for HIV and tuberculosis each consists of combined regimens with three or four drugs....
Eligibility Criteria
Inclusion
- HIV infection, documented by ELISA test
- Adult patients
- Patients co-infected with HIV and Tuberculosis
- Concomitant use of Nevirapine and Rifampicin in patients co-infected with HIV and Tuberculosis
- ART Naïve patients
Exclusion
- Allergy/hypersensitivity to any study drug(s).
- Prior history of documented drug-resistant TB.
- Pregnancy
- Patients with alanine aminotransferase or aspartate aminotransferase levels more than five times the upper limit of normal.
- Chronic liver disease due to cirrhosis of liver, hepatitis B \& C virus infection.
- Chronic alcoholic.
- Non-complaint patients.
- Migrant patients.
- Serious form of pulmonary or extrapulmonary tuberculosis e.g. severe haemoptysis and unconscious patients
- Concomitant diabetes mellitus.
- Epilepsy
- Patients on other immunosuppressive therapy.
- Malignancy other than Kaposi's Sarcoma requiring therapy.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT01805258
Start Date
June 1 2007
End Date
February 1 2013
Last Update
March 26 2013
Active Locations (1)
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1
All India Institute of Medical Sciences
New Delhi, New Delhi, India, 110029