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Simplification From Protease Inhibitors to Raltegravir (ODIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00941083
Recruitment Status : Unknown
Verified September 2009 by Hospital Carlos III, Madrid.
Recruitment status was:  Recruiting
First Posted : July 17, 2009
Last Update Posted : September 10, 2009
Sponsor:
Information provided by:
Hospital Carlos III, Madrid

Tracking Information
First Submitted Date  ICMJE July 14, 2009
First Posted Date  ICMJE July 17, 2009
Last Update Posted Date September 10, 2009
Study Start Date  ICMJE January 2009
Estimated Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00941083 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2009)
  • CD4 gains, lipid profile, adverse events, [ Time Frame: 24 weeks ]
  • Drug resistance mutations [ Time Frame: 24 weeks ]
  • Raltegravir through plasma levels and correlation with virological failure [ Time Frame: 24 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Simplification From Protease Inhibitors to Raltegravir
Official Title  ICMJE Pilot, Open-label, Randomized, Single-center Study to Asses a Simplification Strategy From Protease Inhibitors to Raltegravir: Once Daily Isentress (ODIS)
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 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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)
Publications * 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. doi: 10.1310/hct1104-197.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 16, 2009)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2009
Estimated Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00941083
Other Study ID Numbers  ICMJE HC0509
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospital Carlos III, Vicente Soriano
Study Sponsor  ICMJE Hospital Carlos III, Madrid
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vicente Soriano, Dr Hospital Carlos III
PRS Account Hospital Carlos III, Madrid
Verification Date September 2009

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