Status:

UNKNOWN

Simplification From Protease Inhibitors to Raltegravir

Lead Sponsor:

Hospital Carlos III, Madrid

Conditions:

HIV Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief 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 ...

Eligibility Criteria

Inclusion

  • HIV1 sero-positive using standard diagnostic criteria
  • Plasma viral HIV-RNA below 50 copies/ml within 180 days prior to randomization
  • On therapy with protease inhibitors both ritonavir-boosted or un-boosted for at least 6 months prior to study entry

Exclusion

  • Pregnancy or breast feeding
  • Prior use of Integrase inhibitors
  • Alcohol or substance abuse if according to the investigator opinion would interfere with compliance
  • UIse of investigational medications within 30 days before study entry or during the trial

Key Trial Info

Start Date :

January 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2009

Estimated Enrollment :

240 Patients enrolled

Trial Details

Trial ID

NCT00941083

Start Date

January 1 2009

End Date

December 1 2009

Last Update

September 10 2009

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Hospital Carlos III

Madrid, Madrid, Spain, 28029