Pilot Study of Raltegravir Lipodystrophy IISP

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01164605
• Other study ID #: #37977
• Status: Recruiting
• Phase: N/A
• First received: July 14, 2010
• Last updated: May 16, 2012
• Start date: October 2010
• Est. completion date: June 2013

Study information

• Verified date: May 2012
• Source: Southern California Institute for Research and Education
• Contact: Stephen M Berman, M.D.,Ph.D.
• Phone: (562) 826-8000
• Email: stephen.berman2[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infection

Intervention

Drug:
• Raltegravir
60 tablets (30-day supply)

Locations

Country	Name	City	State
United States	VA Long Beach Healthcare System	Long Beach	California

Sponsors (2)

Lead Sponsor	Collaborator
Southern California Institute for Research and Education	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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.

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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Determining whether the patients will continue to have sustained virological suppression upon switching to a raltegravir-based regimen.		eighteen months	No
Secondary	Determining what, if any, adverse effects the patients may develop..		eighteen months	No

External Links

•   U.S. protocols submitted by US investigators directly or through the Global Research Specialist.