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PRO 140 for Human Immunodeficiency Virus Infection

Primary Purpose

HIV

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PRO 140
Sponsored by
Drexel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Males and females, age ≥18 years
  2. Has not taken any antiretroviral therapy (ART) within 12 weeks of the early screening visit
  3. Screening plasma HIV-1 RNA ≥ 5,000 copies/mL
  4. CD4+ lymphocyte cell count ≥500 cells/mm3 and no documented count less than or equal to 250 cells/mm3
  5. Exclusive CCR5-tropic virus as determined by as determined by the Enhanced Sensitivity Trofile™ HIV Tropism Assay
  6. Clinically normal resting 12-lead ECG at screening visit
  7. 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.

Exclusion Criteria:

  1. CXCR4-tropic virus, dual/mixed tropic (R5X4) virus as determined by the Enhanced Sensitivity Trofile™ HIV Tropism Assay
  2. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
  3. 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)
  4. Chronic hepatitis
  5. Prior use of any entry, attachment, CCR5 coreceptor, or fusion inhibitor, including PRO 140, experimental or approved
  6. Any immunization or vaccination (including influenza vaccine) within 30 days prior to administration of study drug.

Sites / Locations

  • Stanford University (Stanford AIDS Clinical Trials Unit)
  • University of Colorado Denver (Colorado ACTU)
  • Washington University in St. Louis
  • University of Rochester Medical Center
  • Drexel University College of Medicine
  • University of Pennsylvania
  • University of Texas Health Science Center at Houston (Houston AIDS Research team (HART)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Treatment Arm 1

Treatment Arm 2

Treatment Arm 3

Treatment Arm 4

Arm Description

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)

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)

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)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 2, 2014
Last Updated
March 7, 2017
Sponsor
Drexel University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT02257788
Brief Title
PRO 140 for Human Immunodeficiency Virus Infection
Official Title
PRO 140 2103: A Phase 2a, Randomized Study of PRO 140 by Subcutaneous Injection in Adult Subjects With Human Immunodeficiency Virus Type 1 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Unlikely to achieve targeted accrual
Study Start Date
September 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Drexel University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Protocol PRO 140 2103 is a multicenter, randomized parallel group study, conducted in approximately 40 male and female adult subjects (n=10/treatment group) infected with CCR5-tropic HIV-1. Subjects will be randomized into one of four treatment groups. Blood samples for drug concentrations, PD variables, and efficacy variables will be obtained over a 59-day period following initiation of dosing. Safety will be monitored throughout the course of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm 1
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Treatment Arm 2
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Treatment Arm 3
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Treatment Arm 4
Arm Type
Active Comparator
Arm Description
PRO 140: one SC dose, 700 mg (day 1) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5)
Intervention Type
Biological
Intervention Name(s)
PRO 140
Intervention Description
Humanized monoclonal antibody to CCR5
Primary Outcome Measure Information:
Title
Maximum change in viral load following initiation of different dosing regimens of PRO140
Description
Viral Load is Defined as HIV-1 Copies/mL and Expressed as log10 Copies/mL
Time Frame
59 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Jacobson, MD
Organizational Affiliation
Drexel University
Official's Role
Study Chair
Facility Information:
Facility Name
Stanford University (Stanford AIDS Clinical Trials Unit)
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of Colorado Denver (Colorado ACTU)
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Washington University in St. Louis
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Texas Health Science Center at Houston (Houston AIDS Research team (HART)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

PRO 140 for Human Immunodeficiency Virus Infection

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