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Efficacy and Safety of Concomitant Use of Nevirapine and Rifampicin With HIV-TB ("NVP")
This study has been completed.
Sponsor:
All India Institute of Medical Sciences, New Delhi
Collaborator:
National AIDS Control Organisation
Information provided by (Responsible Party):
S.K.SHARMA, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT01805258
First received: March 1, 2013
Last updated: March 25, 2013
Last verified: March 2013
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
| HIV/TB Co-infection | Drug: Nevirapine Drug: Efavirenz | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Efficacy and Safety of Concomitant Use of Nevirapine and Rifampicin in Antiretroviral Naive Patients Co-infected With HIV and Tuberculosis in India. |
Resource links provided by NLM:
Further study details as provided by S.K.SHARMA, All India Institute of Medical Sciences, New Delhi:
Primary Outcome Measures:
- Virological suppression at 48 weeks. [ Time Frame: 5 years ]
All patients underwent a detailed physical examination. Their body weight and height will be measured and their body mass index (BMI) was calculated. Haemoglobin, complete blood counts, erythrocyte sedimentation rate, fasting blood glucose, renal function tests, liver function tests, serum albumin, serum uric acid and routine urinalysis will be done for all patients.
Patients will be assessed at day 14 after the start of ART, then at day 28, 42 and every 4 weeks thereafter through 48 weeks. A complete haemogram, liver and kidney function tests will be obtained at all these visits. CD4 counts will be measured at 8 weeks, 24 weeks and 48 weeks after the start of ART. HIV plasma viral load will be measured at baseline, at 24 weeks and at the end of 48 weeks only in the cases. Trough nevirapine concentrations were assessed at day 14, day 28, day 42 and day 180, 12 hours after the evening dose of nevirapine.
Secondary Outcome Measures:
- Number of Participants with Adverse Events especially Hepatotoxicity as a measure of Safety. [ Time Frame: 5 years ]Drug associated toxicities specially hepatitis were assessed in the subjects by performing liver function tests every 4 weeks during follow-up.
| Enrollment: | 135 |
| Study Start Date: | June 2007 |
| Study Completion Date: | February 2013 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intervention 2: Nevirapine
HIV and Tuberculosis co-infected patients on standard dose nevirapine (Intervention) based ART and Rifampicin based ATT.
|
Drug: Nevirapine
The regimen containing Nevirapine: 3TC/ZDV 150/300 mg 1 tablet BID + NEVIRAPINE 200 mg qD for 2 weeks then 200mg BID
Other Name: NEV-Nevirapine
|
|
Active Comparator: Intervention 2: Efavirenz
HIV and Tuberculosis co-infected patients on standard dose Efavirenz(Intervention)based ART and Rifampicin based ATT.
|
Drug: Efavirenz
The regimen containing Efavirenz: 3TC/ZDV 150/300 mg 1 tablet BID + EFAVIRENZ 600 mg qD
Other Name: EFV: Efavirenz
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01805258
Please refer to this study by its ClinicalTrials.gov identifier: NCT01805258
Locations
| India | |
| All India Institute of Medical Sciences | |
| New Delhi, India, 110029 | |
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
National AIDS Control Organisation
Investigators
| Principal Investigator: | Surendra K Sharma, MD, Ph.D | All India Institute of Medical Science, New Delhi |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | S.K.SHARMA, Professor and Head, All India Institute of Medical Sciences, New Delhi |
| ClinicalTrials.gov Identifier: | NCT01805258 History of Changes |
| Other Study ID Numbers: |
SKS/NACO-1/2006-07 |
| Study First Received: | March 1, 2013 |
| Last Updated: | March 25, 2013 |
Keywords provided by S.K.SHARMA, All India Institute of Medical Sciences, New Delhi:
|
India Nevirapine Rifampicin |
Efavirenz HIV TB |
Additional relevant MeSH terms:
|
Coinfection Infection Virus Diseases Parasitic Diseases Efavirenz Nevirapine Rifampin Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents Leprostatic Agents Cytochrome P-450 CYP2C8 Inducers Cytochrome P-450 CYP2C19 Inducers Cytochrome P-450 CYP2C9 Inducers Anti-HIV Agents |
ClinicalTrials.gov processed this record on June 22, 2017