Clinical Trial: HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Adi

Brief 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 Summary: 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.
Sponsor: Kirby Institute

Current Primary Outcome: To investigate changes in adipocyte structure and function in HIV-infected individuals treated with antiretroviral therapy

Original Primary Outcome: To investigate changes in adipocyte structure and function in HIV-infected individuals treated with antiretroviral therapy.

Current Secondary Outcome:

  • To correlate changes in adipocyte function with changes in body composition and metabolic parameters in individuals beginning their first antiretroviral regimen
  • To examine changes in adipocyte function in HIV-infected volunteers both prior to and after initiation of treatment in order to determine changes arising directly as a result of therapy
  • To investigate changes in adipocyte function in pre-treated HIV-infected volunteers with and without established signs of HIVLD in order to determine if changes in function correlate with particular phenotypes such as lipoatrophy or buffalo hump


Original Secondary Outcome:

  • To correlate changes in adipocyte function with changes in body composition and metabolic parameters in individuals beginning their first antiretroviral regimen.
  • To examine changes in adipocyte function in HIV-infected volunteers both prior to and after initiation of treatment in order to determine changes arising directly as a result of therapy.
  • To investigate changes in adipocyte function in pre-treated HIV-infected volunteers with and without established signs of HIVLD in order to determine if changes in function correlate with particular phenotypes such as lipoatrophy or buffalo hump.


Information By: Kirby Institute

Dates:
Date Received: September 12, 2005
Date Started: February 2003
Date Completion:
Last Updated: April 11, 2012
Last Verified: April 2012