Overview

A Study to Compare Brachial Artery Reactivity and Cardiovascular Risk of a Treatment Simplification by Darunavir/Ritonavir (DRV/r) 800/100 mg Versus a Triple Combination Therapy Containing DRV/r in HIV-1 Infected Patients

Status:
Completed
Trial end date:
2011-04-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare change of brachial artery flow mediated vasodilatation using Darunavir/Ritonavir (DRV/r) 800/100 mg once daily as a monotherapy (use of a single medication) versus a triple combination therapy containing 2 nucleoside reverse transcriptase inhibitors (NRTIs) and DRV/r in Human immunodeficiency virus-1 (HIV-1) infected participants.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen-Cilag S.p.A.
Treatments:
Darunavir
Reverse Transcriptase Inhibitors
Ritonavir
Criteria
Inclusion Criteria: - Human immunodeficiency virus-1 (HIV-1) infected participants on their
first-line treatment with highly active antiretroviral therapy (HAART) (combination of 2 or
3 nucleoside reverse transcriptase inhibitors [NRTIs] with at least 1 additional
antiretroviral [ARV] from the non-nucleoside reverse transcriptase inhibitor [NNRTI] and/or
protease inhibitors [PI] class) for at least 24 weeks, provided the same ARV combination
for at least 8 weeks before screening

- Participants' preference for a more convenient regimen and/or any current or history
of toxicity on actual regimen

- Plasma HIV-1 ribonucleic acid (RNA) less than 50 cp/ml for at least 24 weeks before
screening, where single viral blips of more than 50 copies/mL are allowed

- Cluster of differentiation 4 (CD4) count more than 100/mm3 at the start of HAART and
more than 200/mm3 at screening

- Healthy on the basis of physical examination, medical history, vital signs, clinical
laboratory tests, and 12-lead electrocardiogram performed at screening

- Agrees to protocol-defined use of effective contraception

- Postmenopausal, surgically sterile, or abstinent female participants

Exclusion Criteria:

- History of coronary heart disease, uncontrolled hypertension, peripheral vascular
disease and or cerebrovascular disease

- History of virological failure on highly active antiretroviral therapy, plasma HIV-1
ribonucleic acid more than 500 copies/mL after initial full virological suppression
while on ARV therapy and any PI mutations

- Participants with significantly hepatic and liver insufficiency or diagnosed with
acute viral hepatitis or have active clinically significant diseases and acquired
immune deficiency syndrome (AIDS) defining illness at screening

- Current significant tobacco use, active drug or alcohol use or dependence

- Use of lipid-lowering drugs within 4 weeks prior to study entry and use of
testosterone, anabolic steroids, oral contraceptives or hormonal replacement within 12
weeks prior to study entry or previous or current use of darunavir

- Use of systemic glucocorticoids, long-acting inhaled steroids (inhaled via mouth or
nose), or other immunomodulators within 30 days prior to study entry