Efficacy and Safety of Concomitant Use of Nevirapine and Rifampicin With HIV-TB - Full Text View

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.

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Tuberculosis

Drug Information available for: Rifampin Nevirapine Efavirenz

Genetic and Rare Diseases Information Center resources: Tuberculosis

U.S. FDA Resources

Further study details as provided by All India Institute of Medical Sciences, New Delhi:

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:

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

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Eligibility


Ages Eligible for Study:	18 Years to 60 Years (Adult)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):

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.


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:


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 Anti-HIV Agents Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents Leprostatic Agents Cytochrome P-450 CYP2C8 Inducers Cytochrome P-450 CYP2C19 Inducers Cytochrome P-450 CYP2C9 Inducers

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
Anti-HIV Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Leprostatic Agents
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers

ClinicalTrials.gov processed this record on September 23, 2016

Efficacy and Safety of Concomitant Use of Nevirapine and Rifampicin With HIV-TB ("NVP")