Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CytoDyn, Inc.
ClinicalTrials.gov Identifier:
NCT00110591
First received: May 10, 2005
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

The purpose of the study is to determine the safety and tolerability of PRO 140, an investigational anti-HIV drug, administered via intravenous infusion.

Study hypothesis: Single intravenous doses of PRO 140 can be safely administered to humans and will result in measurable concentrations of the product in serum.


Condition Intervention Phase
HIV Infections
Drug: PRO 140
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I, Randomized, Double Blind, Placebo Controlled, Single-Dose, Rising Dose Cohort Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRO 140 in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by CytoDyn, Inc.:

Primary Outcome Measures:
  • Safety and tolerability of PRO 140 [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: April 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Intravenous placebo for PRO 140
Experimental: PRO 140 dose 1
0.1 mg/kg PRO 140 by intravenous infusion
Drug: PRO 140
Monoclonal antibody to CCR5
Experimental: PRO 140 dose 2
0.5 mg/kg PRO 140 by intravenous infusion
Drug: PRO 140
Monoclonal antibody to CCR5
Experimental: PRO 140 dose 3
2.0 mg/kg PRO 140 by intravenous infusion
Drug: PRO 140
Monoclonal antibody to CCR5
Experimental: PRO 140 dose 4
5.0 mg/kg PRO 140 by intravenous infusion
Drug: PRO 140
Monoclonal antibody to CCR5

Detailed Description:

PRO 140 is a man-made monoclonal antibody to the chemokine receptor CCR5, which serves as a co-receptor for HIV. In numerous preclinical models of HIV infection, PRO 140 broadly and potently blocks CCR5-mediated HIV entry without blocking the natural activity of CCR5. PRO 140 is being developed for therapy of HIV infected individuals. The purpose of this study is to evaluate the safety and tolerability of PRO 140 in HIV uninfected male volunteers. The pharmacokinetics and pharmacodynamics of PRO 140 will also be assessed in this study.

Participants in this study will be randomly assigned to receive a single dose of one of several possible doses of PRO 140 or placebo. Participants will remain in the clinic for observation and evaluation for 24 hours after the single-dose administration. Follow-up visits will occur at 2, 3, 5, 7, 10, 14, 28, 42, and 60 days post-treatment. Physical exams, electrocardiograms (ECGs), vital signs measurement, adverse event reporting, and blood and urine collection will occur at most visits.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Not more than 20% below or 20% above ideal weight for height and estimated frame size
  • Good health, with no clinically significant abnormal findings on the physical examination, medical history, or laboratory tests

Exclusion Criteria:

  • History of clinically significant disease
  • History of clinically significant allergies, including drug allergy
  • Participated in another clinical trial within the 3 months prior to study entry
  • HIV infected
  • Hepatitis B or C virus infected
  • Active significant infection
  • Prior exposure, allergy, or known hypersensitivity to PRO 140
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110591

Locations
United States, Nebraska
MDS Pharma Services
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
CytoDyn, Inc.
Investigators
Study Chair: William Olson, PhD Vice President, Clinical Research, Progenics Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: CytoDyn, Inc.
ClinicalTrials.gov Identifier: NCT00110591     History of Changes
Other Study ID Numbers: 5R44-AI046871-04, PRO140-1101
Study First Received: May 10, 2005
Last Updated: July 9, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 22, 2014