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Study of PRO 140 by Subcutaneous Administration in Adult Subjects With HIV -1 Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CytoDyn, Inc.
ClinicalTrials.gov Identifier:
NCT00642707
First received: March 21, 2008
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

The purpose of this study is:

  1. To assess the antiviral activity of PRO 140
  2. To assess the safety and tolerability of PRO 140
  3. To generate additional PK, PD and safety data of PRO 140

Condition Intervention Phase
HIV -1 Infection
HIV Infections
Drug: PRO 140 (humanized monoclonal antibody to CCR5)
Drug: Placebo Comparator
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2a, Randomized, Double-blind, Placebo Controlled Study of PRO 140 by Subcutaneous Administration in Adult Subjects With Human Immunodeficiency Virus Type 1 Infection

Resource links provided by NLM:


Further study details as provided by CytoDyn, Inc.:

Primary Outcome Measures:
  • Maximum Change in Viral Load Following Initiation of Treatment (Viral Load is Defined as HIV-1 Copies/mL and Expressed as log10 Copies/mL). [ Time Frame: 59 days ] [ Designated as safety issue: No ]
    The primary end point was the maximum change from baseline in viral load following initiation of treatment, defined as HIV-1 copies/mL, measured by the Roche Amplicor HIV-1 Monitor UltraSensitive™ Test (lower limit of detection [LLD] = 48 copies/mL).


Enrollment: 44
Study Start Date: March 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
PRO 140 for three single SC doses: Days 1, 8, and 15
Drug: PRO 140 (humanized monoclonal antibody to CCR5)
Active Comparator: Arm 2
PRO 140 for three single SC doses: Days 1, 8 and 15
Drug: PRO 140 (humanized monoclonal antibody to CCR5)
Active Comparator: Arm 3
PRO 140 for two single SC doses: Days 1 and 15 plus one SC dose of PBO at Day 8
Drug: PRO 140 (humanized monoclonal antibody to CCR5)
Placebo Comparator: Arm 4
PBO for three single SC doses: Days 1, 8 and 15
Drug: Placebo Comparator

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males & females, age ≥ 18 years (or minimum adult age as determined by local regulatory authorities)
  2. Screening plasma HIV-1 RNA ≥ 5,000 copies/mL
  3. CD4+ lymphocyte cell count ≥ 300 cells/mm3 and no documented count < or = 250 cells/mm3
  4. Has not taken any antiretroviral therapy (ART) w/in 12 wks of Early Screening Visit
  5. Exclusive CCR5-tropic virus as determined by Trofile™ Assay at Early Screening Visit
  6. Clinically normal or "not clinically significant (NCS)" resting electrocardiogram
  7. Women of reproductive potential must have a negative serum pregnancy test at Late Screening Visit & a negative urine pregnancy test w/in 72 hrs prior to first dose of study medication, & be non-lactating. Male & female subjects must agree not to participate in a conception process from Early Screening Visit through Day 59.

Exclusion Criteria:

  1. CXCR4 tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ Assay.
  2. Females who are pregnant, lactating or breastfeeding, or who plan to become pregnant during the study.
  3. History of active hepatitis within the previous 24 wks
  4. Prior use of any entry, attachment, CCR5 co-receptor or fusion inhibitor, including PRO 140, experimental or approved.
  5. Any immunization or vaccination (including influenza vaccine) within 30 days prior to administration of study drug.
  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: NCT00642707

Locations
United States, New York
Progenics Pharmaceuticals, Inc.
Tarrytown, New York, United States, 10591
Sponsors and Collaborators
CytoDyn, Inc.
Investigators
Study Director: Stephen Morris, MD, PhD Progenics Pharmaceuticals, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: CytoDyn, Inc.
ClinicalTrials.gov Identifier: NCT00642707     History of Changes
Other Study ID Numbers: PRO 140 2101
Study First Received: March 21, 2008
Results First Received: April 12, 2013
Last Updated: July 9, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: National Institute of Health

Keywords provided by CytoDyn, Inc.:
HIV
Treatment Naïve

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Communicable Diseases
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014