NCT02257788

Brief Summary

PRO 140 2103 is a multicenter, randomized parallel group study, conducted in male and female adult subjects infected with CCR5-tropic HIV-1.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_2 hiv

Geographic Reach
1 country

7 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 2, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 6, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

5 months

First QC Date

October 2, 2014

Last Update Submit

March 7, 2017

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

  • Maximum change in viral load following initiation of different dosing regimens of PRO140

    Viral Load is Defined as HIV-1 Copies/mL and Expressed as log10 Copies/mL

    59 days

Study Arms (4)

Treatment Arm 1

ACTIVE COMPARATOR

PRO 140: one SC dose, 350 mg (day 1), followed by two single SC doses, 350 mg each (days 8 and 15) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5)

Biological: PRO 140

Treatment Arm 2

ACTIVE COMPARATOR

PRO 140: one SC loading dose, 700 mg (day 1), followed by two single SC doses, 350 mg each (days 8 and 15) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5)

Biological: PRO 140

Treatment Arm 3

ACTIVE COMPARATOR

PRO 140: one SC loading dose, 700 mg (day 1), followed by one single SC dose 350 mg (day 15) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5)

Biological: PRO 140

Treatment Arm 4

ACTIVE COMPARATOR

PRO 140: one SC dose, 700 mg (day 1) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5)

Biological: PRO 140

Interventions

PRO 140BIOLOGICAL

Humanized monoclonal antibody to CCR5

Treatment Arm 1Treatment Arm 2Treatment Arm 3Treatment Arm 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females, age ≥18 years
  • Has not taken any antiretroviral therapy (ART) within 12 weeks of the early screening visit
  • Screening plasma HIV-1 RNA ≥ 5,000 copies/mL
  • CD4+ lymphocyte cell count ≥500 cells/mm3 and no documented count less than or equal to 250 cells/mm3
  • Exclusive CCR5-tropic virus as determined by as determined by the Enhanced Sensitivity Trofile™ HIV Tropism Assay
  • Clinically normal resting 12-lead ECG at screening visit
  • Women of reproductive potential must have a negative serum pregnancy test at Late Screening Visit. Within hours prior to receiving the first dose of study drug, women of reproductive potential must have a negative urine pregnancy test. Male and female subjects must agree not to participate in a conception process and agree to use one barrier method of contraception plus one other highly reliable contraceptive method from the early screening visit through three weeks after the last administered subcutaneous dose of PRO 140.

You may not qualify if:

  • CXCR4-tropic virus, dual/mixed tropic (R5X4) virus as determined by the Enhanced Sensitivity Trofile™ HIV Tropism Assay
  • Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
  • Diagnosis of acute viral hepatitis (defined as any active infection with hepatitis A or a new diagnosis of hepatitis B or C within 24 weeks of dosing)
  • Chronic hepatitis
  • Prior use of any entry, attachment, CCR5 coreceptor, or fusion inhibitor, including PRO 140, experimental or approved
  • Any immunization or vaccination (including influenza vaccine) within 30 days prior to administration of study drug.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Stanford University (Stanford AIDS Clinical Trials Unit)

Stanford, California, 94304, United States

Location

University of Colorado Denver (Colorado ACTU)

Denver, Colorado, 80045, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Drexel University College of Medicine

Philadelphia, Pennsylvania, 19102, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas Health Science Center at Houston (Houston AIDS Research team (HART)

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

leronlimab

Study Officials

  • Jeffrey Jacobson, MD

    Drexel University

    STUDY CHAIR
0

Study Design

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

Study Record Dates

First Submitted

October 2, 2014

First Posted

October 6, 2014

Study Start

September 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 9, 2017

Record last verified: 2017-03

Locations

US(7)