NCT01164605

Pilot Study of Raltegravir Lipodystrophy IISP

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Southern California Institute for Research and Education · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infection

Interventions

Type	Name	Description
DRUG	Raltegravir	60 tablets (30-day supply)

Timeline

• Start date: 2010-10-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2010-07-16
• Last updated: 2012-05-18

Locations

1 site across 1 country: United States