Pilot Study of Raltegravir Lipodystrophy IISP

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified May 2012 by Southern California Institute for Research and Education.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01164605

First Posted: July 16, 2010

Last Update Posted: May 18, 2012

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.

Collaborator:

Merck Sharp & Dohme Corp.

Information provided by (Responsible Party):

Southern California Institute for Research and Education

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:	Intervention Model: Single Group Assignment Masking: None (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

Drug Information available for: Raltegravir Raltegravir potassium

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 ]

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 ]
Determining what, if any, adverse effects the patients may develop.. [ Time Frame: eighteen months ]


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:

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

Information from the National Library of Medicine

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Information from the National Library of Medicine

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

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 Sharp & Dohme Corp.

Investigators


Principal Investigator:	Stephen M Berman, M.D., Ph.D.	Southern California Institute for Research and Education

More Information

Publications:

Bickel M, Eisen J, Stephan C, Crespi CM, Lutz T, Klauke S, Vogl TJ, Jacobi V, Yang OO, Staszewski S, Zangos S. A standardized, comprehensive magnetic resonance imaging protocol for rapid and precise quantification of HIV-1-associated lipodystrophy. HIV Med. 2007 Oct;8(7):413-9.

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.

Steigbigel RT, Cooper DA, Teppler H, Eron JJ, Gatell JM, Kumar PN, Rockstroh JK, Schechter M, Katlama C, Markowitz M, Yeni P, Loutfy MR, Lazzarin A, Lennox JL, Clotet B, Zhao J, Wan H, Rhodes RR, Strohmaier KM, Barnard RJ, Isaacs RD, Nguyen BY; BENCHMRK Study Teamsa. Long-term efficacy and safety of Raltegravir combined with optimized background therapy in treatment-experienced patients with drug-resistant HIV infection: week 96 results of the BENCHMRK 1 and 2 Phase III trials. Clin Infect Dis. 2010 Feb 15;50(4):605-12. doi: 10.1086/650002.


Responsible Party:	Southern California Institute for Research and Education
ClinicalTrials.gov Identifier:	NCT01164605 History of Changes
Other Study ID Numbers:	#37977
First Submitted:	July 14, 2010
First Posted:	July 16, 2010
Last Update Posted:	May 18, 2012
Last Verified:	May 2012

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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases	Raltegravir Potassium Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents HIV Integrase Inhibitors Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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