Back to resultsSimplification From Protease Inhibitors to Raltegravir (ODIS)
Primary Purpose
HIV Infections
Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Raltegravir (Use RAL as a simplification strategy)
Raltegravir (Use RAL as a simplification strategy)
Raltegravir (Use RAL as a simplification strategy)
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Simplification from protease inhibitors to raltegravir, Treatment Experienced, HIV-1 Infections
Eligibility 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
Sites / Locations
- Hospital Carlos IIIRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
RAL QD 800 mg/24 hs
RAL BID 400 mg/12 hs
RAL BID to QD
Arm Description
Outcomes
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)
Secondary Outcome Measures
CD4 gains, lipid profile, adverse events,
Drug resistance mutations
Raltegravir through plasma levels and correlation with virological failure
Full Information
NCT ID
NCT00941083
First Posted
July 14, 2009
Last Updated
September 9, 2009
Sponsor
Hospital Carlos III, Madrid
1. Study Identification
Unique Protocol Identification Number
NCT00941083
Brief Title
Simplification From Protease Inhibitors to Raltegravir
Acronym
ODIS
Official Title
Pilot, Open-label, Randomized, Single-center Study to Asses a Simplification Strategy From Protease Inhibitors to Raltegravir: Once Daily Isentress (ODIS)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Carlos III, Madrid
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Simplification from protease inhibitors to raltegravir, Treatment Experienced, HIV-1 Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RAL QD 800 mg/24 hs
Arm Type
Experimental
Arm Title
RAL BID 400 mg/12 hs
Arm Type
Active Comparator
Arm Title
RAL BID to QD
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Raltegravir (Use RAL as a simplification strategy)
Intervention Description
RAL QD: RAL 800 mg/24 hs
Intervention Type
Drug
Intervention Name(s)
Raltegravir (Use RAL as a simplification strategy)
Intervention Description
RAL BID 400 mg/12 hs
Intervention Type
Drug
Intervention Name(s)
Raltegravir (Use RAL as a simplification strategy)
Intervention Description
RAL BID to QD
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
CD4 gains, lipid profile, adverse events,
Time Frame
24 weeks
Title
Drug resistance mutations
Time Frame
24 weeks
Title
Raltegravir through plasma levels and correlation with virological failure
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vicente Soriano, Dr
Organizational Affiliation
Hospital Carlos III
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Carlos III
City
Madrid
ZIP/Postal Code
28029
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vicente Soriano, PhD
Phone
+34914532536
Email
vsoriano@dragonet.es
First Name & Middle Initial & Last Name & Degree
Vicente Soriano, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
20974575
Citation
Vispo E, Barreiro P, Maida I, Mena A, Blanco F, Rodriguez-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.
Results Reference
derived
Learn more about this trial
Simplification From Protease Inhibitors to Raltegravir
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