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SNAP: Switching Nucleoside Analogues Protocol - Lipoatrophy and Mitochondrial Function

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ClinicalTrials.gov Identifier: NCT00225082
Recruitment Status : Completed
First Posted : September 23, 2005
Last Update Posted : October 5, 2010
Sponsor:
Collaborator:
Abbott
Information provided by:
Northwestern University

Tracking Information
First Submitted Date September 21, 2005
First Posted Date September 23, 2005
Last Update Posted Date October 5, 2010
Study Start Date November 2004
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title SNAP: Switching Nucleoside Analogues Protocol - Lipoatrophy and Mitochondrial Function
Official Title SNAP: Switching Nucleoside Analogues Protocol - Lipoatrophy and Mitochondrial
Brief Summary

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

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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
adipose tissue, blood
Sampling Method Non-Probability Sample
Study Population 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.
Condition HIV Infection
Intervention Drug: Nucleoside analogue switch
stavudine switched to tenofovir
Study Groups/Cohorts Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September¬†21,¬†2005)
12
Original Enrollment Same as current
Actual Study Completion Date October 2007
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00225082
Other Study ID Numbers SNAP
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Robert Murphy, MD, Northwestern University
Study Sponsor Northwestern University
Collaborators Abbott
Investigators
Study Chair: Robert L Murphy, MD Northwestern University
Study Chair: Mariana Gerschenson, Ph.D. University of Hawaii
PRS Account Northwestern University
Verification Date October 2010