Long Beach, California 90822

  • HIV Infection

Purpose:

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.


Study summary:

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.


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.


NCT ID:

NCT01164605


Primary Contact:

Principal Investigator
Stephen M Berman, M.D., Ph.D.
Southern California Institute for Research and Education

Stephen M Berman, M.D.,Ph.D.
Phone: (562) 826-8000 ext. 2841
Email: stephen.berman2@va.gov


Backup Contact:

Email: judy.gerken@va.gov
Judy A Gerken, NP
Phone: (562) 826-8000 ext. 5452


Location Contact:

Long Beach, California 90822
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 27, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.