Pilot Study of Raltegravir Lipodystrophy IISP
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|ClinicalTrials.gov Identifier: NCT01164605|
Recruitment Status : Unknown
Verified May 2012 by Southern California Institute for Research and Education.
Recruitment status was: Recruiting
First Posted : July 16, 2010
Last Update Posted : May 18, 2012
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection||Drug: Raltegravir||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study on the Efficacy of a Two Drug, Raltegravir-based Regimen,(NRTI) Sparing Antiretroviral Treatment|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||June 2013|
- Drug: Raltegravir
60 tablets (30-day supply)
- 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 ]
- Determining whether the patients will continue to have sustained virological suppression upon switching to a raltegravir-based regimen. [ Time Frame: eighteen months ]
- Determining what, if any, adverse effects the patients may develop.. [ Time Frame: eighteen months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01164605
|Contact: Stephen M Berman, M.D.,Ph.D.||(562) 826-8000 ext firstname.lastname@example.org|
|Contact: Judy A Gerken, NP||(562) 826-8000 ext email@example.com|
|United States, California|
|VA Long Beach Healthcare System||Recruiting|
|Long Beach, California, United States, 90822|
|Principal Investigator:||Stephen M Berman, M.D., Ph.D.||Southern California Institute for Research and Education|