SNAP: Switching Nucleoside Analogues Protocol - Lipoatrophy and Mitochondrial Function

Northwestern University

Status: Completed

Conditions: HIV Infection

Treatments: Drug: Nucleoside analogue switch

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00225082

SNAP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Volunteers: No Healthy Volunteers

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