SNAP: Switching Nucleoside Analogues Protocol - Lipoatrophy and Mitochondrial Function

HIV Infection Clinical Trial

Official title:

SNAP: Switching Nucleoside Analogues Protocol - Lipoatrophy and Mitochondrial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00225082
• Other study ID #: SNAP
• Status: Completed
• Phase: N/A
• First received: September 21, 2005
• Last updated: October 4, 2010
• Start date: November 2004
• Est. completion date: October 2007

Study information

• Verified date: October 2010
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infection
• Lipodystrophy

Intervention

Drug:
• Nucleoside analogue switch
stavudine switched to tenofovir

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Abbott

Country where clinical trial is conducted

United States, 

References & Publications (1)

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-con — View Citation