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SNAP: Switching Nucleoside Analogues Protocol - Lipoatrophy and Mitochondrial Function

SNAP: Switching Nucleoside Analogues Protocol - Lipoatrophy and Mitochondrial

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00225082
Enrollment
12
Registered
2005-09-23
Start date
2004-11-30
Completion date
2007-10-31
Last updated
2010-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Keywords

Lipoatrophy, Mitochondrial function, Nucleoside analogue switch, Treatment Experienced

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.

Interventions

DRUGNucleoside analogue switch

stavudine switched to tenofovir

Sponsors

Abbott
CollaboratorINDUSTRY
Northwestern University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026