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Clinical Study to Evaluate the Efficacy and Safety of Lopinavir/Ritonavir Monotherapy Versus Darunavir/Ritonavir Monotherapies as Simplification Switching Strategies of PI/NNRTI-Triple Therapy Based-Regimens

NCT00994344 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2014-02-13

No results posted yet for this study

Summary

The purpose of this study is to determine the non-inferiority in the efficacy of DRV/r (900/100 mg) monotherapy at 48 weeks versus LPV/r (400/100 mg) as simplification strategy in subjects with sustained viral suppression on stable PI or NNRTI-antiretroviral regimens.

Conditions

  • HIV Infections

Interventions

DRUG

Darunavir/ritonavir

Darunavir/ritonavir 800/100 mg once daily

DRUG

Lopinavir/ritonavir

Lopinavir/ritonavir 400/100 mg twice daily

Sponsors & Collaborators

  • Germans Trias i Pujol Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Spain

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 NCT00994344 on ClinicalTrials.gov