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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. 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
Information provided by:
Hospital Carlos III, Madrid

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).

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Raltegravir (Use RAL as a simplification strategy) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot, Open-label, Randomized, Single-center Study to Asses a Simplification Strategy From Protease Inhibitors to Raltegravir: Once Daily Isentress (ODIS)
Study Start Date : January 2009
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: RAL QD 800 mg/24 hs Drug: Raltegravir (Use RAL as a simplification strategy)
RAL QD: RAL 800 mg/24 hs

Active Comparator: RAL BID 400 mg/12 hs Drug: Raltegravir (Use RAL as a simplification strategy)
RAL BID 400 mg/12 hs

Experimental: RAL BID to QD Drug: Raltegravir (Use RAL as a simplification strategy)

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. CD4 gains, lipid profile, adverse events, [ Time Frame: 24 weeks ]
  2. Drug resistance mutations [ Time Frame: 24 weeks ]
  3. Raltegravir through plasma levels and correlation with virological failure [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00941083

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Hospital Carlos III Recruiting
Madrid, Spain, 28029
Contact: Vicente Soriano, PhD    +34914532536   
Principal Investigator: Vicente Soriano, PhD         
Sponsors and Collaborators
Hospital Carlos III, Madrid
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Principal Investigator: Vicente Soriano, Dr Hospital Carlos III

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hospital Carlos III, Vicente Soriano Identifier: NCT00941083    
Other Study ID Numbers: HC0509
First Posted: July 17, 2009    Key Record Dates
Last Update Posted: September 10, 2009
Last Verified: September 2009
Keywords provided by Hospital Carlos III, Madrid:
Simplification from protease inhibitors to raltegravir
Treatment Experienced
HIV-1 Infections
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Raltegravir Potassium
HIV Protease Inhibitors
Protease Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action