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Efficacy Safety Study Comparing 2 Doses of NVP After Initiating Rifampin-containing TB Therapy

NCT00476853 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2020-07-17

No results posted yet for this study

Summary

A 48 week, randomized, open-label, two arm study to compare the efficacy, safety and tolerability of HAART containing nevirapine 400 mg/day versus nevirapine 600 mg/day in HIV-1 infected patients started at 2-6 weeks after initiating rifampicin containing antituberculosis therapy.

Conditions

Interventions

DRUG

HAART containing nevirapine

Initially NVP 200 mg BID (400 mg per day) was compared to 400 mg BID and 200 mg OD NVP (600 mg per day). 400 mg/day versus 600 mg/day.

Sponsors & Collaborators

  • other sponsors:Japanese MOPH

    collaborator UNKNOWN

  • Labor and Welfare

    collaborator UNKNOWN

  • Thai MOPH

    collaborator UNKNOWN

  • Thai GPO

    collaborator UNKNOWN

  • Bamrasnaradura Infectious Diseases Institute

    collaborator OTHER_GOV

  • Chiang Rai Hospital

    collaborator OTHER

  • King Chulalongkorn Memorial Hospital

    collaborator OTHER

  • Central General Chest Institute

    collaborator UNKNOWN

  • The Research Institute of Tuberculosis (Japan)

    collaborator UNKNOWN

  • The HIV Netherlands Australia Thailand Research Collaboration

    lead OTHER

Principal Investigators

  • Anchalee Avihingsanon, MD · The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

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
2005-10-31
Primary Completion
2008-09-30
Completion
2009-12-31

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Diseases

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 NCT00476853 on ClinicalTrials.gov