Impact of Antiretroviral Therapy on Metabolic, Skeletal, and Cardiovascular Parameters
Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
Participant gender:
Summary
The U.S. Department of Health and Human Services (HHS) guidelines recommend that HIV-infected
people who have never received anti-HIV therapy be treated with a triple drug regimen
(commonly called combination antiretroviral therapy, cART). Since the introduction of cART,
morbidity and mortality among HIV-infected patients has been dramatically reduced. However,
metabolic, skeletal, and cardiovascular diseases have been increasingly reported among
HIV-infected patients and may be attributable, in part, to the direct effects of cART. Much
of our understanding of the development of these diseases, risk factors, and consequences of
these disorders has been derived from clinical studies of HIV-infected persons receiving
older antiretroviral agents.
A5260s was designed to examine the contributions of HIV-disease related factors and impact of
newer antiretroviral drugs on the development of metabolic (such as blood vessels, blood
sugar, cholesterol), skeletal, and cardiovascular diseases in people who have never received
anti-HIV therapy. A5260s is a prospective substudy of a phase III randomized clinical trial
A5257 (see ClinicalTrials.gov identifier: NCT00811954). A5257 was designed to look at
different combinations of anti-HIV drugs that do not contain the medication efavirenz (EFV)
and how well these drug combinations work to decrease the amount of HIV in the blood and to
allow immune system recovery in people who have never received anti-HIV therapy. A5257 also
examined drug tolerability and safety for the various drug combinations.
Details
Lead Sponsor:
AIDS Clinical Trials Group
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)