Pilot Study of Raltegravir Lipodystrophy IISP

Study Overview
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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.

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.

Official Title
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Pilot Study on the Efficacy of a Two Drug, Raltegravir-based Regimen,(NRTI) Sparing Antiretroviral Treatment

Conditions
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HIV Infection

Intervention / Treatment
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* Drug: Raltegravir


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Raltegravir|60 tablets (30-day supply)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NRTI-regimen, Raltegravir, Elvitegravir, HIV-1 integrase inhibitor, Fat Waste