SNAP: Switching Nucleoside Analogues Protocol - Lipoatrophy and Mitochondrial Function

Completed

• Conditions: HIV Infection

• Registration Number: NCT00225082
• Lead Sponsor: Northwestern University

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 Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-09-21
• Study First Submitted QC: 2005-09-21
• Study First Posted: 2005-09-23
• Primary Completion: 2006-12
• Study Completion: 2007-10
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-04
• Last Update Posted: 2010-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States