Bococizumab HIV Evaluation (B-HIVE) Study

NCT02524106 | Terminated Phase 3 Results DMC

• 1 other identifier: WI204426
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 3

Brief Summary

B-HIVE is a Phase 3, double blind, placebo-controlled, randomized, parallel group study, designed to compare the efficacy and safety of bococizumab 150 mg subcutaneously every 2 weeks to bococizumab placebo subcutaneously every 2 weeks for LDL-C lowering in HIV-infected subjects.

Conditions

Dyslipidemia; Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Change of LDL-C From Baseline to Week 12

  The primary endpoint for the study is the percent change from baseline in fasting LDL-C at week 12.

  week 12

Secondary Outcomes (1)

• Change in Lp(a) From Entry to Week 12

  week 12

Study Arms (2)

Bococizumab

EXPERIMENTAL

150 mg bococizumab injected subcutaneously every 2 weeks for a duration of 52 weeks

Drug: Bococizumab

Placebo

PLACEBO COMPARATOR

150 mg placebo injected subcutaneously every 2 weeks for a duration of 52 weeks

Drug: Placebo

Interventions

Bococizumab DRUG

PF-04950615 is a humanized monoclonal antibody against the proprotein convertase subtilisin kexin type 9 (PCSK9) enzyme responsible for the degradation of the low-density lipoprotein receptor (LDLR), being developed by Pfizer, Inc for the treatment of primary hyperlipidemia and mixed dyslipidemia.

Also known as: PF-04950615

Bococizumab

Placebo DRUG

placebo

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Males and females greater than 40 years of age.
• With documented HIV infection.
• Moderate or high CVD risk defined as:
• documented CVD as assessed by meeting at least 1 of 3 criteria below:
• Coronary artery disease (CAD): prior MI due to atherosclerosis, coronary artery bypass graft surgery, percutaneous coronary intervention, or angiographic CAD with luminal diameter stenosis of at least one coronary artery at least 50%.
• Cerebrovascular disease: prior ischemic stroke of carotid origin, carotid endarterectomy or stenting, or angiographic carotid stenosis of at least 50%.
• Peripheral arterial disease: prior lower extremity arterial surgical or percutaneous revascularization procedure, or angiographic lower extremity arterial stenosis of at least 50%.
• OR any one of the following CVD risk factors:
• Controlled type II diabetes mellitus (HbA1C ≤8.0% within the past 90 days prior to study entry, regardless of use of medications)
• Current smoking: participant report of smoking at least a half a pack of cigarettes a day, on average, in the past month.
• Hypertension: two consecutive BP readings with either systolic \>140 mmHg or diastolic \>90 mmHg; or on antihypertensive medications.
• Dyslipidemia: defined as or HDL-C ≤ 40 mg/dL for men or ≤50 mg/dL for women, regardless of medication use.
• a hsCRP ≥2mg/L at screening.

You may not qualify if:

• Subjects who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees.
• Participation in other studies involving small molecule investigational drug(s) (Phases 1 4) within 1 month 5 half lives, whichever is longer except for cholesteryl ester transfer protein (CETP) inhibitors (indefinitely), or biological agents within 6 months or 5 half lives, whichever is longer before the current study begins and/or during study participation (the investigator should refer to documents provided by the subject on the other study to determine the investigational product half life). If the blind has been broken and the Investigator knows (with documentation) that the subject received placebo, he/she can be included.
• Subjects with prior exposure to bococizumab or another PCSK9 inhibitor.
• Subjects who are unable to receive injections, as either a self-injection, or administered by another person.
• History of a cardiovascular or cerebrovascular event or procedure (eg, myocardial infarction, stroke, transient ischemic attack, angioplasty) during the past 90 days.
• Poorly controlled hypertension (on or off treatment) at screening visit or at randomization (defined as the average of two systolic blood pressure (BP) measurements greater than 160 mm Hg or the average of two diastolic BP measurements greater than 100 mm Hg).
• Any history of hemorrhagic stroke or lacunar infarct.
• CD4 count at screening visit \<350 cells/mm3.
• Current untreated hypothyroidism or thyroid stimulating hormone (TSH) \>1 X upper limit of normal (ULN) at screening. Subjects who are treated and well controlled should be on a stable dose of thyroid hormone for at least 6 months.
• Current history of alcoholism or drug addiction according to the Diagnostic and Statistical Manual of Mental Disorders (DSM) IV criteria within 12 months prior to screening. Use of any recreational drugs within 12 months prior to screening.
• History of cancer within the last 5 years (except for cutaneous basal cell or squamous cell cancer resolved by excision, or cervical carcinoma in si tu).
• Any disease or condition that might compromise the hematological, renal, hepatic, pulmonary, endocrine, central nervous, immune, or gastrointestinal systems (unless deemed not clinically significant by the Investigator and/or the Sponsor) or confound the interpretation of the study results. Examples of such conditions include but are not limited to nephrotic syndrome, uncontrolled diabetes, excessive alcohol consumption, cholestatic liver disease, unstable mental illness.
• Undergoing apheresis or have a planned start of apheresis.
• Initiation of or change in non-lipid lowering prescription drugs, herbal medicine or supplements (including foods with added plant sterols and stanols) within 6 weeks of screening with the exception of initiation or change in multivitamins used for general health purposes. Short-term use of medications to treat acute conditions, and vaccines are allowed (e.g., antibiotics or allergy medication).
• History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody (IgG protein) or molecules made of components of monoclonal antibodies (eg, Enbrel® which contains the Fc portion of an antibody or Lucentis® which is a Fab).

Sponsors & Collaborators

• University of California, San Francisco: lead
• Pfizer: collaborator
• San Francisco General Hospital: collaborator

Study Sites (3)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Quest Clinical Research

San Francisco, California, 94115, United States

Location

San Francisco Veteran's Affair Medical Center

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Dyslipidemias; Cardiovascular Diseases

Interventions

bococizumab

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Priscilla Hsue, PI
• Organization: University of California San Francisco

priscilla.hsue@ucsf.edu

415-206-8257

Study Officials

• Priscilla Y Hsue, MD

  priscilla.hsue@ucsf.edu

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2015
• First Posted: August 14, 2015
• Study Start: August 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: June 19, 2019
• Results First Posted: June 19, 2019

Record last verified: 2019-06

Locations

US (3)