SNAP: Switching Nucleoside Analogues Protocol - Lipoatrophy and Mitochondrial Function - Full Text View

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:

MedlinePlus related topics: HIV/AIDS

Genetic and Rare Diseases Information Center resources: Lipodystrophy

U.S. FDA Resources

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:

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:

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.


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

ClinicalTrials.gov processed this record on February 27, 2015