SNAP: Switching Nucleoside Analogues Protocol - Lipoatrophy and Mitochondrial Function
|ClinicalTrials.gov Identifier: NCT00225082|
Recruitment Status : Completed
First Posted : September 23, 2005
Last Update Posted : October 5, 2010
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|
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|
|Actual Enrollment :||12 participants|
|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|
- Drug: Nucleoside analogue switch
stavudine switched to tenofovir
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
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Study Chair:||Robert L Murphy, MD||Northwestern University|
|Study Chair:||Mariana Gerschenson, Ph.D.||University of Hawaii|