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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

Study Description
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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.


Condition or disease Intervention/treatment
HIV Infection Drug: Nucleoside analogue switch

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 Design
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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: SNAP: Switching Nucleoside Analogues Protocol - Lipoatrophy and Mitochondrial
Study Start Date : November 2004
Actual Primary Completion Date : December 2006
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
    Drug: Nucleoside analogue switch
    stavudine switched to tenofovir

Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Biospecimen Retention:   Samples Without DNA
adipose tissue, blood

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00225082


Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Abbott
Investigators
Study Chair: Robert L Murphy, MD Northwestern University
Study Chair: Mariana Gerschenson, Ph.D. University of Hawaii
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Responsible Party: Robert Murphy, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00225082     History of Changes
Other Study ID Numbers: SNAP
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: October 5, 2010
Last Verified: October 2010

Keywords provided by Northwestern University:
Lipoatrophy
Mitochondrial function
Nucleoside analogue switch
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Lipodystrophy
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
 Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases