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Pilot Study of Raltegravir Lipodystrophy IISP

This study is currently recruiting participants.
Verified May 2012 by Southern California Institute for Research and Education
Sponsor:
Collaborator:
Merck
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
History of Changes
  Purpose

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.


Condition Intervention
HIV Infection
 Drug: Raltegravir

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study on the Efficacy of a Two Drug, Raltegravir-based Regimen,(NRTI) Sparing Antiretroviral Treatment

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Southern California Institute for Research and Education:

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. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: October 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Raltegravir
    60 tablets (30-day supply)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01164605

Contacts
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

Locations
United States, California
VA Long Beach Healthcare System Recruiting
Long Beach, California, United States, 90822
Sponsors and Collaborators
Southern California Institute for Research and Education
Merck
Investigators
Principal Investigator: Stephen M Berman, M.D., Ph.D. Southern California Institute for Research and Education
  More Information

Publications:
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.
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.

Responsible Party: Southern California Institute for Research and Education
ClinicalTrials.gov Identifier: NCT01164605     History of Changes
Other Study ID Numbers: #37977
Study First Received: July 14, 2010
Last Updated: May 16, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Southern California Institute for Research and Education:
NRTI-regimen
Raltegravir
Elvitegravir
HIV-1 integrase inhibitor
Fat Waste

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on March 07, 2013