Status:
UNKNOWN
Pilot Study of Raltegravir Lipodystrophy IISP
Lead Sponsor:
Southern California Institute for Research and Education
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HIV Infection
Eligibility:
All Genders
Phase:
NA
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 us...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01164605
Start Date
October 1 2010
End Date
June 1 2013
Last Update
May 18 2012
Active Locations (1)
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1
VA Long Beach Healthcare System
Long Beach, California, United States, 90822