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

NCT01805258 | Completed Phase 3

• 1 other identifier: SKS/NACO-1/2006-07
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

HIV/TB Co-infection

Keywords

India; Nevirapine; Rifampicin; Efavirenz; HIV; TB

Outcome Measures

Primary Outcomes (1)

• Virological suppression at 48 weeks.

  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.

  5 years

Secondary Outcomes (1)

• Number of Participants with Adverse Events especially Hepatotoxicity as a measure of Safety.

  5 years

Study Arms (2)

Intervention 2: Nevirapine

EXPERIMENTAL

HIV and Tuberculosis co-infected patients on standard dose nevirapine (Intervention) based ART and Rifampicin based ATT.

Drug: Nevirapine

Intervention 2: Efavirenz

ACTIVE COMPARATOR

HIV and Tuberculosis co-infected patients on standard dose Efavirenz(Intervention)based ART and Rifampicin based ATT.

Drug: Efavirenz

Interventions

Nevirapine DRUG

The regimen containing Nevirapine: 3TC/ZDV 150/300 mg 1 tablet BID + NEVIRAPINE 200 mg qD for 2 weeks then 200mg BID

Also known as: NEV-Nevirapine

Intervention 2: Nevirapine

Efavirenz DRUG

The regimen containing Efavirenz: 3TC/ZDV 150/300 mg 1 tablet BID + EFAVIRENZ 600 mg qD

Also known as: EFV: Efavirenz

Intervention 2: Efavirenz

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead
• National AIDS Control Organisation: collaborator

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, New Delhi, 110029, India

Location

Related Publications (2)

• Sinha S, Gupta K, Tripathy S, Dhooria S, Ranjan S, Pandey RM. Nevirapine- versus Efavirenz-based antiretroviral therapy regimens in antiretroviral-naive patients with HIV and Tuberculosis infections in India: a multi-centre study. BMC Infect Dis. 2017 Dec 11;17(1):761. doi: 10.1186/s12879-017-2864-0.

  PMID: 29228918 DERIVED

• 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.

  PMID: 24134449 DERIVED

MeSH Terms

Interventions

Nevirapine; efavirenz

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Surendra K Sharma, MD, Ph.D

  All India Institute of Medical Science, New Delhi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head

Study Record Dates

• First Submitted: March 1, 2013
• First Posted: March 6, 2013
• Study Start: June 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: February 1, 2013
• Last Updated: March 26, 2013

Record last verified: 2013-03

Locations

IN (1)