Pilot Study of Raltegravir Lipodystrophy IISP

Not Applicable

• Conditions: HIV Infection

• Registration Number: NCT01164605
• Lead Sponsor: Southern California Institute for Research and Education

Brief Summary

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.

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 Timeline

• Study First Submitted: 2010-07-14
• Study First Submitted QC: 2010-07-15
• Study First Posted: 2010-07-16
• Study Start: 2010-10
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-16
• Last Update Posted: 2012-05-18
• Primary Completion: 2013-06
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	one year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

VA Long Beach Healthcare System; 🇺🇸 Long Beach, California, United States