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SNAP: Switching Nucleoside Analogues Protocol - Lipoatrophy and Mitochondrial Function

NCT ID: NCT00225082

Last Updated: 2010-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-11-30

Study Completion Date

2007-10-31

Brief Summary

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HIV infected subjects receiving antiretroviral treatment for greater than 6 years with be evaluated for clinical lipoatrophy and mitochondrial function after switching nucleoside analogues from stavudine (d4T) to tenofovir treatment and after 4.

Hypothesis: Tenofovir therapy will increase peripheral fat content as assessed by DEXA and mitochondrial function at 48 weeks.

Detailed Description

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HIV infected subjects receiving antiretroviral treatment (lopinavir/ritonavir, stavudine, and lamivudine) for greater than 6 years through the Abbott M97-720 protocol with be evaluated for clinical lipoatrophy and mitochondrial function prior to switching nucleoside analogues from stavudine (d4T) to tenofovir and after 48 weeks or tenofovir treatment.

Subjects with or without lipoatrophy are eligible for the study. Adipose tissue biopsies to measure mitochondrial function, metabolic laboratory tests, and DAXA scans and clinical evaluations of lipodystrophy will be performed at Entry and after 48 weeks of tenofovir treatment.

Conditions

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HIV Infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Nucleoside analogue switch

stavudine switched to tenofovir

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* HIV infection
* Receiving Kaletra, stavudine, and lamivudine for greater than 6 years (through Abbott M97-720 study)
* Planning to switch from stavudine to tenofovir

Exclusion Criteria

* Will continue to receive stavudine
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Northwestern University

Principal Investigators

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Robert L Murphy, MD

Role: STUDY_CHAIR

Northwestern University

Mariana Gerschenson, Ph.D.

Role: STUDY_CHAIR

University of Hawaii

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Gerschenson M, Kim C, Berzins B, Taiwo B, Libutti DE, Choi J, Chen D, Weinstein J, Shore J, da Silva B, Belsey E, McComsey GA, Murphy RL. Mitochondrial function, morphology and metabolic parameters improve after switching from stavudine to a tenofovir-containing regimen. J Antimicrob Chemother. 2009 Jun;63(6):1244-50. doi: 10.1093/jac/dkp100. Epub 2009 Mar 25.

Reference Type RESULT
PMID: 19321503 (View on PubMed)

Other Identifiers

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SNAP

Identifier Type: -

Identifier Source: org_study_id