NCT00192660

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Kirby Institute · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, non-randomised, 48 week study of the effect of protease inhibitor (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.

Detailed description

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.

Conditions

• HIV-Associated Lipodystrophy Syndrome
• Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	Lamivudine
DRUG	Stavudine
DRUG	Didanosine
DRUG	Zidovudine
DRUG	Tenofovir
DRUG	Abacavir
DRUG	Efavirenz (EFV)
DRUG	Nevirapine
DRUG	Indinavir
DRUG	Saquinavir
DRUG	Amprenavir
DRUG	Ritonavir
DRUG	Nelfinavir
DRUG	Tipranavir
DRUG	enfuvirtide (T20)

Timeline

• Start date: 2003-02-01
• Primary completion: 2006-10-01
• Completion: 2007-12-01
• First posted: 2005-09-19
• Last updated: 2012-04-12

Locations

1 site across 1 country: Australia