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

This study has been completed.
Sponsor:
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
  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:


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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HIV infection, documented by ELISA test
  2. Adult patients
  3. Patients co-infected with HIV and Tuberculosis
  4. Concomitant use of Nevirapine and Rifampicin in patients co-infected with HIV and Tuberculosis
  5. ART Naïve patients

Exclusion Criteria:

  1. Allergy/hypersensitivity to any study drug(s).
  2. Prior history of documented drug-resistant TB.
  3. Pregnancy
  4. Patients with alanine aminotransferase or aspartate aminotransferase levels more than five times the upper limit of normal.
  5. Chronic liver disease due to cirrhosis of liver, hepatitis B & C virus infection.
  6. Chronic alcoholic.
  7. Non-complaint patients.
  8. Migrant patients.
  9. Serious form of pulmonary or extrapulmonary tuberculosis e.g. severe haemoptysis and unconscious patients
  10. Concomitant diabetes mellitus.
  11. Epilepsy
  12. Patients on other immunosuppressive therapy.
  13. 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

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

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:
Coinfection
Infection
Virus Diseases
Parasitic Diseases
Rifampin
Efavirenz
Nevirapine
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
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on October 01, 2014