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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01805258 |
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Date of registration:
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01/03/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of Concomitant Use of Nevirapine and Rifampicin With HIV-TB
"NVP" |
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Scientific title:
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Efficacy and Safety of Concomitant Use of Nevirapine and Rifampicin in Antiretroviral Naive Patients Co-infected With HIV and Tuberculosis in India. |
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Date of first enrolment:
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June 2007 |
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Target sample size:
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135 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01805258 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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India
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Contacts
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Name:
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Surendra K Sharma, MD, Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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All India Institute of Medical Science, New Delhi |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV/TB Co-infection
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Intervention(s)
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Drug: Nevirapine
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Drug: Efavirenz
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Primary Outcome(s)
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Virological suppression at 48 weeks.
[Time Frame: 5 years]
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Secondary Outcome(s)
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Number of Participants with Adverse Events especially Hepatotoxicity as a measure of Safety.
[Time Frame: 5 years]
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Secondary ID(s)
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SKS/NACO-1/2006-07
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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