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Pilot Study of Raltegravir Lipodystrophy IISP

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Southern California Institute for Research and Education.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Southern California Institute for Research and Education
ClinicalTrials.gov Identifier:
NCT01164605
First received: July 14, 2010
Last updated: May 16, 2012
Last verified: May 2012

July 14, 2010
May 16, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01164605 on ClinicalTrials.gov Archive Site
  • Determining whether the patients will continue to have sustained virological suppression upon switching to a raltegravir-based regimen. [ Time Frame: eighteen months ] [ Designated as safety issue: No ]
  • Determining what, if any, adverse effects the patients may develop.. [ Time Frame: eighteen months ] [ Designated as safety issue: No ]
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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
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.
Both
Not Provided
No
Contact: Stephen M Berman, M.D.,Ph.D. (562) 826-8000 ext 2841 stephen.berman2@va.gov
Contact: Judy A Gerken, NP (562) 826-8000 ext 5452 judy.gerken@va.gov
United States
 
NCT01164605
#37977
No
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