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An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.

NCT00081588 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 555

Last updated 2014-06-20

No results posted yet for this study

Summary

The primary objective of the TMC114-C215 study is to evaluate the safety and tolerability of TMC114/RTV over time. The secondary objectives are to evaluate the antiviral activity over time and to evaluate the immunological effect over time.

Conditions

  • HIV Infection

Interventions

DRUG

TMC114

600/100 mg tablets of TMC114/rtv BID for 144 weeks or until commercial available

Sponsors & Collaborators

  • Tibotec Pharmaceuticals, Ireland

    lead INDUSTRY

Principal Investigators

  • Tibotec Pharmaceuticals Clinical Trial · Tibotec Pharmaceutical Limited

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-30
Primary Completion
2005-09-30
Completion
2008-12-31

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • France
  • Germany
  • Hungary
  • Portugal
  • Spain
  • United Kingdom

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 NCT00081588 on ClinicalTrials.gov