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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01805258
Recruitment Status : Completed
First Posted : March 6, 2013
Last Update Posted : March 26, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
HIV/TB Co-infection Drug: Nevirapine Drug: Efavirenz Phase 3

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : June 2007
Primary Completion Date : December 2012
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Virological suppression at 48 weeks. [ Time Frame: 5 years ]

    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 :
  1. Number of Participants with Adverse Events especially Hepatotoxicity as a measure of Safety. [ Time Frame: 5 years ]
    Drug associated toxicities specially hepatitis were assessed in the subjects by performing liver function tests every 4 weeks during follow-up.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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):
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
First Posted: March 6, 2013    Key Record Dates
Last Update Posted: March 26, 2013
Last Verified: March 2013

Keywords provided by S.K.SHARMA, 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
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Leprostatic Agents
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Anti-HIV Agents