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A Study to Determine the Antiviral Activity of TMC310911 When Administered With Ritonavir in Treatment-Naive Human Immunodeficiency Virus - Type 1 (HIV-1) Infected Patients

NCT00838162 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2013-06-12

Study results available
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Summary

The purpose of this study is to evaluate the antiviral activity as measured by the change in viral load from baseline in the 14 days following initiation of treatment with 4 different dose regimens of TMC310911 co-administered with ritonavir.

Conditions

  • Human Immunodeficiency Virus Type 1

Interventions

DRUG

TMC310911 75 mg twice daily

TMC310911 75 mg twice daily orally (by mouth) on Days 1 to 14.

DRUG

TMC310911 150 mg twice daily

TMC310911 150 mg twice daily orally (by mouth) on Days 1 to 14

DRUG

TMC310911 300 mg twice daily

TMC310911 300 mg twice daily orally (by mouth) on Days 1 to 14

DRUG

TMC310911 300 mg once daily

TMC310911 300 mg once daily orally (by mouth) on Days 1 to 14

DRUG

Ritonavir 100 mg twice daily

Ritonavir 100 mg twice daily orally (by mouth) on Days 1 to 14

DRUG

Ritonavir 100 mg once daily

Ritonavir 100 mg once daily orally (by mouth) on Days 1 to 14

Sponsors & Collaborators

  • Tibotec Pharmaceuticals, Ireland

    lead INDUSTRY

Principal Investigators

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

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
2009-06-30
Primary Completion
2009-08-31
Completion
2011-02-28

Countries

  • Germany

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 NCT00838162 on ClinicalTrials.gov