Efficacy and Safety of Concomitant Use of Nevirapine and Rifampicin With HIV-TB ("NVP")
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ClinicalTrials.gov Identifier: NCT01805258 |
Recruitment Status
:
Completed
First Posted
: March 6, 2013
Last Update Posted
: March 26, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV/TB Co-infection | Drug: Nevirapine Drug: Efavirenz | Phase 3 |

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 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | February 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: Intervention 2: Nevirapine
HIV and Tuberculosis co-infected patients on standard dose nevirapine (Intervention) based ART and Rifampicin based ATT.
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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
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Active Comparator: Intervention 2: Efavirenz
HIV and Tuberculosis co-infected patients on standard dose Efavirenz(Intervention)based ART and Rifampicin based ATT.
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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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- 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.
- 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.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
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.

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
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 |
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 |