NCT01164605

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

May 18, 2012

Status Verified

May 1, 2012

Enrollment Period

2.7 years

First QC Date

July 14, 2010

Last Update Submit

May 16, 2012

Conditions

HIV Infection

Keywords

NRTI-regimenRaltegravirElvitegravirHIV-1 integrase inhibitorFat Waste

Outcome Measures

Primary Outcomes (1)

  • 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.

    one year

Secondary Outcomes (2)

  • Determining whether the patients will continue to have sustained virological suppression upon switching to a raltegravir-based regimen.

    eighteen months

  • Determining what, if any, adverse effects the patients may develop..

    eighteen months

Interventions

RaltegravirDRUG

60 tablets (30-day supply)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Long Beach Healthcare System

Long Beach, California, 90822, United States

RECRUITING

Related Publications (4)

  • Bickel M, Eisen J, Stephan C, Crespi CM, Lutz T, Klauke S, Vogl TJ, Jacobi V, Yang OO, Staszewski S, Zangos S. A standardized, comprehensive magnetic resonance imaging protocol for rapid and precise quantification of HIV-1-associated lipodystrophy. HIV Med. 2007 Oct;8(7):413-9. doi: 10.1111/j.1468-1293.2007.00487.x.

    PMID: 17760732BACKGROUND

  • Efficacy, safety and tolerability of dual therapy with raltegravir and atazanavir in antiretroviral experienced patients. D. Ripamonti, F. Maggiolo, E. Bombana, et al. Presented at the 5th IAS Conference on HIV Pathogenesis, Treatment and Prevention, July 19-22, 2010, Cape Town, South Africa.

    BACKGROUND

  • Raltegravir without a protease inhibitor is highly efficacious in heavily pre-treated individuals. D. Skiest, C. Cohen, D. Barker, M. Gottlieb, et al. Presented at the 5th IAS Conference on HIV Pathogenesis, Treatment and Prevention, July 19-22, 2010, Cape Town, South Africa.

    BACKGROUND

  • Steigbigel RT, Cooper DA, Teppler H, Eron JJ, Gatell JM, Kumar PN, Rockstroh JK, Schechter M, Katlama C, Markowitz M, Yeni P, Loutfy MR, Lazzarin A, Lennox JL, Clotet B, Zhao J, Wan H, Rhodes RR, Strohmaier KM, Barnard RJ, Isaacs RD, Nguyen BY; BENCHMRK Study Teamsa. Long-term efficacy and safety of Raltegravir combined with optimized background therapy in treatment-experienced patients with drug-resistant HIV infection: week 96 results of the BENCHMRK 1 and 2 Phase III trials. Clin Infect Dis. 2010 Feb 15;50(4):605-12. doi: 10.1086/650002.

    PMID: 20085491BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Stephen M Berman, M.D., Ph.D.

    Southern California Institute for Research and Education

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

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

Judy A Gerken, NP

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2010

First Posted

July 16, 2010

Study Start

October 1, 2010

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

May 18, 2012

Record last verified: 2012-05

Locations

US(1)