Pilot Study of Raltegravir Lipodystrophy IISP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Southern California Institute for Research and Education

July 14, 2010
July 16, 2010
May 18, 2012
October 2010
June 2013   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01164605 on Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
Pilot Study of Raltegravir Lipodystrophy IISP
Pilot Study on the Efficacy of a Two Drug, Raltegravir-based Regimen,(NRTI) Sparing Antiretroviral Treatment
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.

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.

Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
HIV Infection
Drug: Raltegravir
60 tablets (30-day supply)
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
June 2013
June 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. HIV-1 positive
  2. Any patient on a boosted PI plus 2 NRTIs.
  3. Visual evidence peripheral fat wasting
  4. HIV-1 viral load fully suppressed at least 9mths.

Exclusion Criteria:

  1. Historical resistance to PI patient receiving
  2. No prior exposure to raltegravir, elvitegravir, other HIV-1 integrase inhibitor.
  3. No contraindications to serial MRI scanning.
  4. No contraindications to utilization of raltegravir.
  5. Not currently receiving any medications drug-drug interaction w/ raltegravir.
Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Southern California Institute for Research and Education
Southern California Institute for Research and Education
Merck Sharp & Dohme Corp.
Principal Investigator: Stephen M Berman, M.D., Ph.D. Southern California Institute for Research and Education
Southern California Institute for Research and Education
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP