SNAP: Switching Nucleoside Analogues Protocol - Lipoatrophy and Mitochondrial Function

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lipid Metabolism Disorders Lipodystrophy Metabolic Diseases Nutritional and Metabolic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Metabolic Skin and Connective Tissue Diseases Urogenital Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nucleoside analogue switch

Drug

stavudine switched to tenofovir

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

Abbott

Registry information

Official study title

SNAP: Switching Nucleoside Analogues Protocol - Lipoatrophy and Mitochondrial

Important dates

Study start: 2004
Primary completion: 2006
Study completion: 2007
First posted: Sep 23, 2005
Registry last updated: Oct 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed