Recruiting

Raltegravir

Sponsor:

Southern California Institute for Research and Education

Code:

NCT01164605

Conditions

HIV Infection

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Raltegravir

Study Details

Brief 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.

Conditions

HIV Infection

Study ID

NCT01164605

Start date

Oct, 2010

Status verified date

May, 2012

Completion date

Jun, 2013

Anticipated

Primary completion date

Jun, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Raltegravir

60 tablets (30-day supply)

Primary outcome measure

  • 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. [ Time Frame: one year ]

Central Contacts and Locations

Central contacts

Stephen M Berman, M.D.,Ph.D.

(562) 826-8000stephen.berman2@va.gov

Judy A Gerken, NP

(562) 826-8000judy.gerken@va.gov

Locations

VA Long Beach Healthcare System

Recruiting

Long Beach, California, United States, 90822

More Information

Sponsor

Southern California Institute for Research and Education

Last update posted

May 18, 2012

Last verified

May, 2012

Keywords

  • NRTI-regimen
  • Raltegravir
  • Elvitegravir
  • HIV-1 integrase inhibitor
  • Fat Waste

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Southern California Institute for Research and Education on 2012-05-18.