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Treatment Simplification by Darunavir/Ritonavir 800/100 mg Once a Day Versus a Triple Combination Therapy With Darunavir/Ritonavir

NCT00458302 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2012-12-19

Study results available
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Summary

The purpose of the study is to compare the efficacy, safety and tolerability of darunavir/ritonavir 800/100 mg once a day (O.D.) as a monotherapy versus a triple combination therapy containing 2 nucleosides and darunavir/ritonavir in 250 HIV-1 infected patients who have been on Highly Active Antiretroviral Therapy (HAART) and have plasma viral load below 50 copies/ml for at least 24 weeks.

Conditions

  • HIV Infections
  • AIDS Virus
  • Human Immunodeficiency Virus
  • Acquired Immunodeficiency Syndrome Virus

Interventions

DRUG

darunavir (DRV, TMC114)

800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks

DRUG

darunavir (DRV, TMC114)

800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks

Sponsors & Collaborators

  • Janssen-Cilag International NV

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag International NV Clinical Trial · Janssen-Cilag International NV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2009-02-28
Completion
2011-01-31

Countries

  • Austria
  • Belgium
  • Denmark
  • Germany
  • Hungary
  • Israel
  • Portugal
  • Russia
  • Spain
  • Switzerland
  • 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 NCT00458302 on ClinicalTrials.gov