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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
History of Changes
  Purpose

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 Intervention Phase
HIV Infections
 Drug: Raltegravir (Use RAL as a simplification strategy)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Hospital Carlos III, Madrid:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 240
Study Start Date: January 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
RAL BID to QD

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941083

Locations
Spain
Hospital Carlos III Recruiting
Madrid, Spain, 28029
Contact: Vicente Soriano, PhD     +34914532536     vsoriano@dragonet.es    
Principal Investigator: Vicente Soriano, PhD            
Sponsors and Collaborators
Hospital Carlos III, Madrid
Investigators
Principal Investigator: Vicente Soriano, Dr Hospital Carlos III
  More Information

No publications provided by Hospital Carlos III, Madrid

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hospital Carlos III, Vicente Soriano
ClinicalTrials.gov Identifier: NCT00941083     History of Changes
Other Study ID Numbers: HC0509
Study First Received: July 14, 2009
Last Updated: September 9, 2009
Health Authority: Spain: Ministry of Health

Keywords provided by Hospital Carlos III, Madrid:
Simplification from protease inhibitors to raltegravir
Treatment Experienced
HIV-1 Infections

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013