Simplification From Protease Inhibitors to Raltegravir (ODIS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Hospital Carlos III, Madrid.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Carlos III, Madrid
ClinicalTrials.gov Identifier:
NCT00941083
First received: July 14, 2009
Last updated: September 9, 2009
Last verified: September 2009

July 14, 2009
September 9, 2009
January 2009
December 2009   (final data collection date for primary outcome measure)
Proportion of patients with plasma HIV-RNA < 50 copies/ml at week 24 in each arm (RAL QD, RAL BID, RAL BID to QD) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00941083 on ClinicalTrials.gov Archive Site
  • CD4 gains, lipid profile, adverse events, [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Drug resistance mutations [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Raltegravir through plasma levels and correlation with virological failure [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Simplification From Protease Inhibitors to Raltegravir
Pilot, Open-label, Randomized, Single-center Study to Asses a Simplification Strategy From Protease Inhibitors to Raltegravir: Once Daily Isentress (ODIS)

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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • 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
  • Experimental: RAL QD 800 mg/24 hs
    Intervention: Drug: Raltegravir (Use RAL as a simplification strategy)
  • Active Comparator: RAL BID 400 mg/12 hs
    Intervention: Drug: Raltegravir (Use RAL as a simplification strategy)
  • Experimental: RAL BID to QD
    Intervention: Drug: Raltegravir (Use RAL as a simplification strategy)
Vispo E, Barreiro P, Maida I, Mena A, Blanco F, Rodríguez-Novoa S, Morello J, Jimenez-Nacher I, Gonzalez-Lahoz J, Soriano V. Simplification from protease inhibitors to once- or twice-daily raltegravir: the ODIS trial. HIV Clin Trials. 2010 Jul-Aug;11(4):197-204.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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
Both
18 Years and older
No
Spain
 
NCT00941083
HC0509
Yes
Hospital Carlos III, Vicente Soriano
Hospital Carlos III, Madrid
Not Provided
Principal Investigator: Vicente Soriano, Dr Hospital Carlos III
Hospital Carlos III, Madrid
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP