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Simplification From Protease Inhibitors to Raltegravir

NCT00941083 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2009-09-10

No results posted yet for this study

Summary

A switch from protease inhibitors (PIs) to raltegravir (RAL) will be effective virologically and immunologically. Moreover, it will be associated with significant improvements in the lipid profile in HIV patients with undetectable viremia on PIs. In this setting, RAL once a day (QD) will perform as well as RAL twice a day (BID).

Conditions

  • HIV Infections

Interventions

DRUG

Raltegravir (Use RAL as a simplification strategy)

RAL QD: RAL 800 mg/24 hs

DRUG

Raltegravir (Use RAL as a simplification strategy)

RAL BID 400 mg/12 hs

DRUG

Raltegravir (Use RAL as a simplification strategy)

RAL BID to QD

Sponsors & Collaborators

  • Hospital Carlos III, Madrid

    lead OTHER

Principal Investigators

  • Vicente Soriano, Dr · Hospital Carlos III

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-12-31
Completion
2009-12-31

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 NCT00941083 on ClinicalTrials.gov