Efficacy and Safety of Concomitant Use of Nevirapine and Rifampicin With HIV-TB ("NVP")
This study has been completed.
National AIDS Control Organisation
Information provided by (Responsible Party):
S.K.SHARMA, All India Institute of Medical Sciences, New Delhi
First received: March 1, 2013
Last updated: March 25, 2013
Last verified: March 2013
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).
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||Efficacy and Safety of Concomitant Use of Nevirapine and Rifampicin in Antiretroviral Naive Patients Co-infected With HIV and Tuberculosis in India.
Primary Outcome Measures:
- Virological suppression at 48 weeks. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
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:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2012 (Final data collection date for primary outcome measure)
Experimental: Intervention 2: Nevirapine
HIV and Tuberculosis co-infected patients on standard dose nevirapine (Intervention) based ART and Rifampicin based ATT.
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.
The regimen containing Efavirenz: 3TC/ZDV 150/300 mg 1 tablet BID + EFAVIRENZ 600 mg qD
Other Name: EFV: Efavirenz
|Ages Eligible for Study:
||18 Years to 60 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- Allergy/hypersensitivity to any study drug(s).
- Prior history of documented drug-resistant TB.
- 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.
- Patients on other immunosuppressive therapy.
- Malignancy other than Kaposi's Sarcoma requiring therapy.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01805258
|All India Institute of Medical Sciences
|New Delhi, India, 110029 |
All India Institute of Medical Sciences, New Delhi
National AIDS Control Organisation
||Surendra K Sharma, MD, Ph.D
||All India Institute of Medical Science, New Delhi
No publications provided by All India Institute of Medical Sciences, New Delhi
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Sinha S, Raghunandan P, Chandrashekhar R, Sharma SK, Kumar S, Dhooria S, Ekka M, Velpandian T, Ranjan S, Ahmad H, Samantaray JC, Venkatesh S, Rewari BB, Khan NH, Pandey RM. Nevirapine versus efavirenz-based antiretroviral therapy regimens in antiretroviral-naive patients with HIV and tuberculosis infections in India: a pilot study. BMC Infect Dis. 2013 Oct 17;13:482. doi: 10.1186/1471-2334-13-482.
||S.K.SHARMA, Professor and Head, All India Institute of Medical Sciences, New Delhi
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 1, 2013
||March 25, 2013
||India: Ministry of Health
Keywords provided by All India Institute of Medical Sciences, New Delhi:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on February 10, 2016
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Reverse Transcriptase Inhibitors