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
  Purpose

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 Intervention
HIV Infection
Drug: Nucleoside analogue switch

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: SNAP: Switching Nucleoside Analogues Protocol - Lipoatrophy and Mitochondrial

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Biospecimen Retention:   Samples Without DNA

adipose tissue, blood


Enrollment: 12
Study Start Date: November 2004
Study Completion Date: October 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Nucleoside analogue switch
    stavudine switched to tenofovir
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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:
Responsible Party: Robert Murphy, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00225082     History of Changes
Other Study ID Numbers: SNAP
Study First Received: September 21, 2005
Last Updated: October 4, 2010
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 01, 2014