Pilot Study of Raltegravir Lipodystrophy IISP

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Raltegravir

60 tablets (30-day supply)

Intervention Type DRUG

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No