Pilot Study of Raltegravir Lipodystrophy IISP

• Status: Unknown status
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southern California Institute for Research and Education
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Raltegravir Potassium

Criteria

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.