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SNAP: Switching Nucleoside Analogues Protocol - Lipoatrophy and Mitochondrial Function

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00225082
First received: September 21, 2005
Last updated: October 4, 2010
Last verified: October 2010

September 21, 2005
October 4, 2010
November 2004
December 2006   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00225082 on ClinicalTrials.gov Archive Site
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Not Provided
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SNAP: Switching Nucleoside Analogues Protocol - Lipoatrophy and Mitochondrial Function
SNAP: Switching Nucleoside Analogues Protocol - Lipoatrophy and Mitochondrial

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

adipose tissue, blood

Non-Probability Sample

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.

HIV Infection
Drug: Nucleoside analogue switch
stavudine switched to tenofovir
Not Provided
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. Epub 2009 Mar 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
October 2007
December 2006   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00225082
SNAP
No
Robert Murphy, MD, Northwestern University
Northwestern University
Abbott
Study Chair: Robert L Murphy, MD Northwestern University
Study Chair: Mariana Gerschenson, Ph.D. University of Hawaii
Northwestern University
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP