Clincosm LogoSign in Get a demo

PRO 140 for Human Immunodeficiency Virus Infection

Sponsor
Drexel University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02257788
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
0
Enrollment
7
Locations
4
Arms
5
Duration (Months)
0
Patients Per Site
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: PRO 140
 Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Feb 1, 2015
Actual Study Completion Date :
Feb 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Treatment Arm 1

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
Humanized monoclonal antibody to CCR5
Active Comparator: Treatment Arm 2

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
Humanized monoclonal antibody to CCR5
Active Comparator: Treatment Arm 3

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
Humanized monoclonal antibody to CCR5
Active Comparator: Treatment Arm 4

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

Biological: PRO 140
Humanized monoclonal antibody to CCR5

Outcome Measures

Primary Outcome Measures

  1. Maximum change in viral load following initiation of different dosing regimens of PRO140 [59 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University (Stanford AIDS Clinical Trials Unit) Stanford California United States 94304
2 University of Colorado Denver (Colorado ACTU) Denver Colorado United States 80045
3 Washington University in St. Louis St. Louis Missouri United States 63110
4 University of Rochester Medical Center Rochester New York United States 14642
5 Drexel University College of Medicine Philadelphia Pennsylvania United States 19102
6 University of Pennsylvania Philadelphia Pennsylvania United States 19104
7 University of Texas Health Science Center at Houston (Houston AIDS Research team (HART) Houston Texas United States 77030

Sponsors and Collaborators

  • Drexel University
  • National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Jeffrey Jacobson, MD, Drexel University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Drexel University
ClinicalTrials.gov Identifier:
NCT02257788
Other Study ID Numbers:
  • 1210001606
  • 5U01AI095085-03
First Posted:
Oct 6, 2014
Last Update Posted:
Mar 9, 2017
Last Verified:
Mar 1, 2017
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Leronlimab

Study Results

No Results Posted as of Mar 9, 2017