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TMC114-C202: A Study of Safety, Efficacy, and Tolerability of TMC114 and Low Dose Ritonavir in HIV-1 Infected Patients

NCT00071097 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2016-09-20

No results posted yet for this study

Summary

The purpose of this study is to determine the effectiveness, safety, and tolerability (how well the body stands the drug) of an investigational protease inhibitor (PI) called TMC114 given with low dose ritonavir.

Conditions

  • HIV Infections

Interventions

DRUG

TMC114/rtv

800mg TMC114/100mg rtv once daily

DRUG

TMC114/rtv

400mg TMC114/100mg rtv both twice daily

DRUG

TMC114/rtv

400mg TMC114/100mg rtv once daily

DRUG

TMC114/rtv

600mg TMC114/100mg rtv twice daily

Sponsors & Collaborators

  • Tibotec Pharmaceuticals, Ireland

    lead INDUSTRY

Principal Investigators

  • Tibotec Pharmaceuticals Clinical Trial · Tibotec Pharmaceutical Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2005-02-28
Completion
2007-11-30

Countries

  • United States
  • Argentina

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 NCT00071097 on ClinicalTrials.gov