Pilot Study of Raltegravir Lipodystrophy IISP

Status unconfirmed · Not applicable

Conditions studied: HIV Infection

In brief

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.

Key facts

Study ID

NCT01164605

Run by

Southern California Institute for Research and Education

People needed

30

Starts

2010-10-01

Expected to finish

2013-06-01

Last updated by the study team

2012-05-18

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• VA Long Beach Healthcare System — Long Beach, California, United States (enrolling)

Full record on ClinicalTrials.gov

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