Pilot Study of Raltegravir Lipodystrophy IISP
Primary Purpose
HIV Infection
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Raltegravir
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infection focused on measuring NRTI-regimen, Raltegravir, Elvitegravir, HIV-1 integrase inhibitor, Fat Waste
Eligibility Criteria
Inclusion Criteria:
- HIV-1 positive
- Any patient on a boosted PI plus 2 NRTIs.
- Visual evidence peripheral fat wasting
- HIV-1 viral load fully suppressed at least 9mths.
Exclusion Criteria:
- Historical resistance to PI patient receiving
- No prior exposure to raltegravir, elvitegravir, other HIV-1 integrase inhibitor.
- No contraindications to serial MRI scanning.
- No contraindications to utilization of raltegravir.
- Not currently receiving any medications drug-drug interaction w/ raltegravir.
Sites / Locations
- VA Long Beach Healthcare SystemRecruiting
Outcomes
Primary Outcome Measures
Determine if the substitution of raltegravir for 2 NRTI's in patients with evidence of peripheral lipoatrophy and who have sustained HIV virological suppression will result in evidence of an increased in volume of peripheral fat within one year.
Secondary Outcome Measures
Determining whether the patients will continue to have sustained virological suppression upon switching to a raltegravir-based regimen.
Determining what, if any, adverse effects the patients may develop..
Full Information
NCT ID
NCT01164605
First Posted
July 14, 2010
Last Updated
May 16, 2012
Sponsor
Southern California Institute for Research and Education
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01164605
Brief Title
Pilot Study of Raltegravir Lipodystrophy IISP
Official Title
Pilot Study on the Efficacy of a Two Drug, Raltegravir-based Regimen,(NRTI) Sparing Antiretroviral Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Southern California Institute for Research and Education
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The substitution of raltegravir for the NRTIs will result in some reversal of the long term adverse effect of lipodystrophy (specifically peripheral lipoatrophy) that is associated with the chronic use of NRTIs. Changing the HAART regimen in patients with a sustained virological response from a PI plus NRTI to a regimen of the PI plus raltegravir will likely result in continued virologic efficacy.
Detailed Description
A prospective, non-controlled, non-randomized, single center study of a treatment regimen of a protease inhibitor or a non-nucleoside reverse transcriptase inhibitor in combination with raltegravir in patients with HIV-1 infection who have been, and continue to be, fully controlled on a standard HAART regimen of a PI or an NNRTI plus 2 NRTIs, and the effect of the change in regimen on peripheral fat distribution.
This pilot study will contain 30 patients who will be followed over a period of one year starting from the date of the medication change from an NRTI-based regimen to a raltegravir-based NRTI-sparing regimen. Potential changes in fat distribution (fat content as assessed by fat volume) will be measured with serial MRI's of the thighs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
NRTI-regimen, Raltegravir, Elvitegravir, HIV-1 integrase inhibitor, Fat Waste
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Raltegravir
Intervention Description
60 tablets (30-day supply)
Primary Outcome Measure Information:
Title
Determine if the substitution of raltegravir for 2 NRTI's in patients with evidence of peripheral lipoatrophy and who have sustained HIV virological suppression will result in evidence of an increased in volume of peripheral fat within one year.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Determining whether the patients will continue to have sustained virological suppression upon switching to a raltegravir-based regimen.
Time Frame
eighteen months
Title
Determining what, if any, adverse effects the patients may develop..
Time Frame
eighteen months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HIV-1 positive
Any patient on a boosted PI plus 2 NRTIs.
Visual evidence peripheral fat wasting
HIV-1 viral load fully suppressed at least 9mths.
Exclusion Criteria:
Historical resistance to PI patient receiving
No prior exposure to raltegravir, elvitegravir, other HIV-1 integrase inhibitor.
No contraindications to serial MRI scanning.
No contraindications to utilization of raltegravir.
Not currently receiving any medications drug-drug interaction w/ raltegravir.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen M Berman, M.D.,Ph.D.
Phone
(562) 826-8000
Ext
2841
Email
stephen.berman2@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Judy A Gerken, NP
Phone
(562) 826-8000
Ext
5452
Email
judy.gerken@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen M Berman, M.D., Ph.D.
Organizational Affiliation
Southern California Institute for Research and Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Long Beach Healthcare System
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
17760732
Citation
Bickel M, Eisen J, Stephan C, Crespi CM, Lutz T, Klauke S, Vogl TJ, Jacobi V, Yang OO, Staszewski S, Zangos S. A standardized, comprehensive magnetic resonance imaging protocol for rapid and precise quantification of HIV-1-associated lipodystrophy. HIV Med. 2007 Oct;8(7):413-9. doi: 10.1111/j.1468-1293.2007.00487.x.
Results Reference
background
Citation
Efficacy, safety and tolerability of dual therapy with raltegravir and atazanavir in antiretroviral experienced patients. D. Ripamonti, F. Maggiolo, E. Bombana, et al. Presented at the 5th IAS Conference on HIV Pathogenesis, Treatment and Prevention, July 19-22, 2010, Cape Town, South Africa.
Results Reference
background
Citation
Raltegravir without a protease inhibitor is highly efficacious in heavily pre-treated individuals. D. Skiest, C. Cohen, D. Barker, M. Gottlieb, et al. Presented at the 5th IAS Conference on HIV Pathogenesis, Treatment and Prevention, July 19-22, 2010, Cape Town, South Africa.
Results Reference
background
PubMed Identifier
20085491
Citation
Steigbigel RT, Cooper DA, Teppler H, Eron JJ, Gatell JM, Kumar PN, Rockstroh JK, Schechter M, Katlama C, Markowitz M, Yeni P, Loutfy MR, Lazzarin A, Lennox JL, Clotet B, Zhao J, Wan H, Rhodes RR, Strohmaier KM, Barnard RJ, Isaacs RD, Nguyen BY; BENCHMRK Study Teamsa. Long-term efficacy and safety of Raltegravir combined with optimized background therapy in treatment-experienced patients with drug-resistant HIV infection: week 96 results of the BENCHMRK 1 and 2 Phase III trials. Clin Infect Dis. 2010 Feb 15;50(4):605-12. doi: 10.1086/650002.
Results Reference
background
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Pilot Study of Raltegravir Lipodystrophy IISP
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