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Efficacy Study of Substitution of Darunavir/Ritonavir (DRV/r) for Dual-boosted Protease Inhibitors

NCT00543101 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-07-21

Study results available
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Summary

This study will evaluate patients who have achieved virologic suppression (\< 400 copies/mL) on any dual protease inhibitor (PI) combination, to determine whether patients can substitute both PIs with the single boosted PI darunavir given 600/100 ritonavir (RTV) twice daily (BID) and maintain comparable virologic suppression (% \< 50 c/mL) for 24 weeks.

Conditions

  • HIV Infections

Interventions

DRUG

Darunavir (DRV/r)

Switch to DRV/r at a dose of 600/100 BID for 48 weeks

DRUG

continue on current dual boosted PI

Continue on current dual boosted PI until week 24. At week 24, participants will be allowed to cross over to the DRV/r arm provided that they have maintained virologic suppression (\< 400 copies/ml) for the first 24-weeks of the study and be followed for an additional 24 weeks

Sponsors & Collaborators

  • Community Research Initiative of New England

    lead OTHER

Principal Investigators

  • Calvin J Cohen, MD, MSc · CRI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • United States

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 NCT00543101 on ClinicalTrials.gov