Efficacy and Safety of Concomitant Use of Nevirapine and Rifampicin With HIV-TB ("NVP")
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Endpoint Classification: Safety/Efficacy Study 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. |
- 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.
- Number of Participants with Adverse Events especially Hepatotoxicity as a measure of Safety. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| India | |
| All India Institute of Medical Sciences | |
| New Delhi, India, 110029 | |
| Principal Investigator: | Surendra K Sharma, MD, Ph.D | All India Institute of Medical Science, New Delhi |
More Information
No publications provided
| 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 |
| Health Authority: | India: Ministry of Health |
Keywords provided by All India Institute of Medical Sciences, New Delhi:
|
India Nevirapine Rifampicin |
Efavirenz HIV TB |
Additional relevant MeSH terms:
|
Rifampin Nevirapine Efavirenz Antibiotics, Antitubercular Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antitubercular Agents |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Leprostatic Agents Nucleic Acid Synthesis Inhibitors Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Reverse Transcriptase Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013