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Simplification From Protease Inhibitors to Raltegravir (ODIS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by Hospital Carlos III, Madrid.
Recruitment status was:  Recruiting
Information provided by:
Hospital Carlos III, Madrid Identifier:
First received: July 14, 2009
Last updated: September 9, 2009
Last verified: September 2009
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
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)

Resource links provided by NLM:

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 ]

Secondary Outcome Measures:
  • 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 ]

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)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00941083

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hospital Carlos III, Vicente Soriano Identifier: NCT00941083     History of Changes
Other Study ID Numbers: HC0509
Study First Received: July 14, 2009
Last Updated: September 9, 2009

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

Additional relevant MeSH terms:
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
Protease Inhibitors
HIV 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 processed this record on September 21, 2017