SNAP: Switching Nucleoside Analogues Protocol - Lipoatrophy and Mitochondrial Function
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Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infection |
Drug: Nucleoside analogue switch |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | SNAP: Switching Nucleoside Analogues Protocol - Lipoatrophy and Mitochondrial |
adipose tissue, blood
| Enrollment: | 12 |
| Study Start Date: | November 2004 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
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Drug: Nucleoside analogue switch
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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
Contacts and Locations| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| Study Chair: | Robert L Murphy, MD | Northwestern University |
| Study Chair: | Mariana Gerschenson, Ph.D. | University of Hawaii |
More Information
Publications:
| Responsible Party: | Robert Murphy, MD, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00225082 History of Changes |
| Other Study ID Numbers: | SNAP |
| Study First Received: | September 21, 2005 |
| Last Updated: | October 4, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Northwestern University:
|
Lipoatrophy Mitochondrial function Nucleoside analogue switch Treatment Experienced |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lipodystrophy Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Skin Diseases, Metabolic Skin Diseases Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013