Impact of Antiretroviral Therapy on Metabolic, Skeletal, and Cardiovascular Parameters

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.

Conditions

• HIV Infection

Interventions

DRUG

Emtricitabine/tenofovir disoproxil fumarate

200 mg emtricitabine/300 mg tenofovir disoproxil fumarate taken orally daily. A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs). Other Name: TDF/FTC

DRUG

Ritonavir

100 mg taken orally once daily. A protease inhibitor (PI). Other Name: RTV

DRUG

Atazanavir

300 mg taken orally once daily. A protease inhibitor (PI). Other Name: ATV

DRUG

Raltegravir

400 mg taken orally twice daily. An integrase inhibitor (INI). Other Name: RAL

DRUG

Darunavir

100 mg taken orally once daily. A protease inhibitor (PI). Other Name: RTV

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

  lead NETWORK

Principal Investigators

• Todd Brown, MD, PhD · Johns Hopkins University

• James Stein, MD · University of Wisconsin, Madison

• Grace McComsey, MD, FIDSA · University Hospitals Cleveland Medical Center

• Judith Currier, MD, MSc · UCLA AIDS Prevention & Treatment CTU

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-06-30

Primary Completion

2013-06-30

Completion

2013-06-30

Countries

• United States

Study Locations