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

NCT01805258 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2013-03-26

No results posted yet for this study

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

Interventions

DRUG

Nevirapine

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

DRUG

Efavirenz

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

Sponsors & Collaborators

  • National AIDS Control Organisation

    collaborator OTHER

  • All India Institute of Medical Sciences

    lead OTHER

Principal Investigators

  • Surendra K Sharma, MD, Ph.D · All India Institute of Medical Science, New Delhi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2012-12-31
Completion
2013-02-28

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01805258 on ClinicalTrials.gov