HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001)
Analysis of Lipodystrophy in HIV-Infected Individuals A Prospective, Non-randomised, 48 Week Study of the Effect of PI Containing and Non-PI Containing Antiretroviral Regimens on the Expression of Adipocyte Specific Genes, Protein Levels and Cellular Structure in HIV-infected Individuals, Naive to Therapy, Who Are Starting Therapy for the First Time
Sponsor: Kirby Institute
This PHASE4 trial investigates Cardiovascular Disease and HIV-Associated Lipodystrophy Syndrome and is currently completed. Kirby Institute leads this study, which shows 6 recorded versions since 2003 — indicating limited longitudinal coverage. Heart and vascular conditions benefit from the kind of long-term tracking this trial provides.
Study Description(click to expand)Antiretroviral medications, used to treat HIV infection, cause side effects. These include changes in composition of fat throughout the body (loss in some areas and accumulation in others), elevations in blood lipids and abnormalities in glucose metabolism. The resulting syndrome is known as "HIV associated lipodystrophy" or HIVLD. In HIV negative populations, such abnormalities in lipid and glucose metabolism are associated with an increased risk of developing cardiovascular disease (CVD). The aim of this study is to characterize the changes that occur in body composition and metabolism with antiretroviral treatment and compare them to changes in fat tissue structure and function and surrogate markers for cardiovascular disease.
Antiretroviral medications, used to treat HIV infection, cause side effects. These include changes in composition of fat throughout the body (loss in some areas and accumulation in others), elevations in blood lipids and abnormalities in glucose metabolism. The resulting syndrome is known as "HIV associated lipodystrophy" or HIVLD. In HIV negative populations, such abnormalities in lipid and glucose metabolism are associated with an increased risk of developing cardiovascular disease (CVD). The aim of this study is to characterize the changes that occur in body composition and metabolism with antiretroviral treatment and compare them to changes in fat tissue structure and function and surrogate markers for cardiovascular disease.
Status Flow
Change History
6 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE4
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Sep 2024 — Present [monthly]
Completed PHASE4
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE4
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Jan 2021 — Jul 2024 [monthly]
Completed PHASE4
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE4
▶ Show 1 earlier version
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Jan 2017 — Jun 2018 [monthly]
Completed PHASE4
First recorded
Feb 2003
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Kirby Institute
- National Heart, Lung, and Blood Institute (NHLBI)
- St Vincent's Hospital, Sydney
For direct contact, visit the study record on ClinicalTrials.gov .