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

NCT ID: NCT01391013

Last Updated: 2013-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-04-30

Brief 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.

Detailed Description

This is a Phase II, randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention), controlled, single centre study. The study consists of 3 phases including, the screening phase (4 weeks before administration of study medication), treatment phase (48 weeks), and the follow-up phase (4 weeks). In the treatment phase, HIV-infected participants who have not changed their first-line treatment of highly active antiretroviral therapy (HAART) for at least 8 weeks and have documented evidence of their HIV- ribonucleic acid (RNA) measurements being virologically suppressed (HIV-RNA less than 50 copies/mL) for at least 24 weeks prior to the screening, will be randomly assigned equally in two treatment arms: triple combination therapy arm (DRV/r 800/100 mg once daily plus 2 NRTIs) or monotherapy arm (DRV/r 800/100 mg once daily). Participants in the triple combination arm who are already on 2 NRTIs prior to randomization may remain on these or switch them at baseline, where the participants on the monotherapy arm will discontinue HAART at baseline and will start DRV/r 800/100 mg once daily. Safety evaluations will include assessment of adverse events, significant vital signs, and significant laboratory tests. The total duration of the study will be 56 weeks.

Conditions

Human Immunodeficiency Virus 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Monotherapy

Monotherapy: darunavir/ritonavir (DRV/r) will be administered for 48 weeks.

Group Type: EXPERIMENTAL

Darunavir(DRV)

Intervention Type: DRUG

Oral administration of tablet DRV 800 mg (2 tablets of 400 mg) once daily at the same time, within 30 minutes after food for 48 weeks

Ritonavir

Intervention Type: DRUG

Oral administration of tablet ritonavir 100 mg once daily at the same time, within 30 minutes after food for 48 weeks

Combination therapy

DRV/r along with 2 nucleoside reverse transcriptase inhibitors (NRTIs) will be administered for 48 weeks and whenever possible, participants should take these medications at the same time. Switch of NRTIs will be allowed in the event of suspected toxicity/intolerance, providing this change can be linked to a documented adverse event (AE)/serious AE.

Group Type: EXPERIMENTAL

Darunavir(DRV)

Intervention Type: DRUG

Oral administration of tablet DRV 800 mg (2 tablets of 400 mg) once daily at the same time, within 30 minutes after food for 48 weeks

Ritonavir

Intervention Type: DRUG

Oral administration of tablet ritonavir 100 mg once daily at the same time, within 30 minutes after food for 48 weeks

2 nucleoside reverse transcriptase inhibitors (NRTIs)

Intervention Type: DRUG

2 NRTIs will be administered as per the package inserts.

Interventions

Darunavir(DRV)

Oral administration of tablet DRV 800 mg (2 tablets of 400 mg) once daily at the same time, within 30 minutes after food for 48 weeks

Intervention Type: DRUG

Ritonavir

Oral administration of tablet ritonavir 100 mg once daily at the same time, within 30 minutes after food for 48 weeks

Intervention Type: DRUG

2 nucleoside reverse transcriptase inhibitors (NRTIs)

2 NRTIs will be administered as per the package inserts.

Intervention Type: DRUG

Other Intervention Names

Prezista

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag S.p.A. Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag S.p.A.

Other Identifiers

TMC114HIV3017

Identifier Type: OTHER

Identifier Source: secondary_id

TMC-C-07-IT-016

Identifier Type: OTHER

Identifier Source: secondary_id

CR017575

Identifier Type: -

Identifier Source: org_study_id