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

NCT01391013 | Completed Phase 2 Results

• 3 other identifiers: CR017575TMC114HIV3017TMC-C-07-IT-016
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Human Immunodeficiency Virus 1

Keywords

Human immunodeficiency virus 1; Acquired immunodeficiency syndrome; Immunologic deficiency syndrome; Darunavir/ritonavir; Darunavir; Ritonavir; Nucleoside reverse transcriptase inhibitors (NRTIs); Prezista

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 24 in Brachial Artery Flow Mediated Vasodilatation (FMD): Median Change in FMD (%)

  Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia (an increase in the quantity of blood flow to a body part) induced relative to the resting brachial artery diameter. Percentage of brachial artery diameter is measured as FMD diameter/basal diameter.

  Baseline (Day 1 of Week 1) to Week 24

Secondary Outcomes (16)

• Change From Baseline to Week 48 in Brachial Artery FMD: Median Change in FMD (%)

  Baseline to Week 48

• Number of Participants With a Human Immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) Greater Than or Equal to 50 Copies/mL

  Screening (Week -4), Week 1 (Day 1), Week 4, Week 12, Week 24, Week 36, Week 48, and follow-up (Week 52)

• Change From Baseline to Week 48 in Circulating Endothelial Cells

  Baseline to Week 48

• Change From Baseline to Week 48 in Precursors of Circulating Endothelial Cells

  Baseline to Week 48

• Change From Baseline in Mean Low-density Lipoprotein (LDL) Cholesterol at Week 24 and Week 48: Median Change in LDL

  Baseline (Day1 of Week 1), Week 24, and Week 48

Study Arms (2)

Monotherapy

EXPERIMENTAL

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

Drug: Darunavir(DRV); Drug: Ritonavir

Combination therapy

EXPERIMENTAL

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.

Drug: Darunavir(DRV); Drug: Ritonavir; Drug: 2 nucleoside reverse transcriptase inhibitors (NRTIs)

Interventions

Darunavir(DRV) 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

Also known as: Prezista

Combination therapy; Monotherapy

Ritonavir DRUG

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

Combination therapy; Monotherapy

2 nucleoside reverse transcriptase inhibitors (NRTIs) DRUG

2 NRTIs will be administered as per the package inserts.

Combination therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag S.p.A.: lead

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes

Interventions

Darunavir; Ritonavir

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Azoles

Results Point of Contact

• Title: Therapeutic Area Medical Manager
• Organization: Jan-Cil Italy

39 02 2510589

Study Officials

• Janssen-Cilag S.p.A. Clinical Trial

  Janssen-Cilag S.p.A.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: July 11, 2011
• Study Start: June 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: June 27, 2013
• Results First Posted: June 27, 2013

Record last verified: 2013-05