Pilot Study of Raltegravir Lipodystrophy IISP

May 16, 2012 updated by: Southern California Institute for Research and Education

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90822
        • Recruiting
        • VA Long Beach Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Determining whether the patients will continue to have sustained virological suppression upon switching to a raltegravir-based regimen.
Time Frame: eighteen months
eighteen months
Determining what, if any, adverse effects the patients may develop..
Time Frame: eighteen months
eighteen months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southern California Institute for Research and Education

Collaborators

Merck Sharp & Dohme LLC

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

July 14, 2010

First Submitted That Met QC Criteria

July 15, 2010

First Posted (Estimate)

July 16, 2010

Study Record Updates

Last Update Posted (Estimate)

May 18, 2012

Last Update Submitted That Met QC Criteria

May 16, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #37977

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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