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A Study of TMC278 in Human Immunodeficiency Virus Type 1 Infected Patients, Who Are Not Treated With Antiretroviral Medicines

NCT00110305 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 368

Last updated 2014-06-25

Study results available
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Summary

The purpose of this study is to evaluate the dose-response relationship of antiviral activity after 48 weeks treatment with 3 different dose regimens of TMC278.

Conditions

  • Human Immunodeficiency Virus Type 1

Interventions

DRUG

TMC278 25 mg

TMC278 25 mg tablet will be administered once daily.

DRUG

TMC278 75 mg

TMC278 75 mg (1 X 25 mg + 1 X 50 mg) tablets will be administered once daily.

DRUG

TMC278 150 mg

TMC278 150 mg (1 X 50 mg + 1 X 100 mg) tablets will be administered once daily.

DRUG

Efavirenz

Efavirenz 600 mg (1 x 600 mg tablet or 3 x 200 mg capsules, depending on formulation locally available) will be administered once daily.

DRUG

Non-nucleoside reverse transcriptase inhibitor (NRTIs)

Investigator selected 2 NRTIs: (1) Zidovudine and lamivudine (Combivir) and (2) tenofovir disoproxil fumarate and emtricitabine (Truvada) will be administered as per the package inserts, along with the TMC278 during the study period.

Sponsors & Collaborators

  • Tibotec Pharmaceuticals, Ireland

    lead INDUSTRY

Principal Investigators

  • Tibotec Pharmaceuticals, Ireland Clinical Trial · Tibotec Pharmaceuticals, Ireland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States
  • Argentina
  • Austria
  • Brazil
  • China
  • France
  • Germany
  • Mexico
  • Puerto Rico
  • Russia
  • South Africa
  • Thailand
  • Uganda
  • 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 NCT00110305 on ClinicalTrials.gov