Trial record 3 of 36 for:    PRO-140

PRO 140 by IV Administration in Adults With HIV-1 Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CytoDyn, Inc.
ClinicalTrials.gov Identifier:
NCT00613379
First received: January 30, 2008
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

The purpose of this study is:

  1. To assess and characterize the PK and PD of PRO 140 administered IV
  2. To assess the antiviral activity of PRO 140
  3. To assess the safety and tolerability of PRO 140

Condition Intervention Phase
HIV Infections
Drug: PRO 140
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of PRO 140 by Intravenous 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. [ 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: 30
Study Start Date: December 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
10 mg/kg PRO 140, one IV dose (N=10)
Drug: PRO 140
10 mg/kg PRO 140, one IV dose (N=10)
Experimental: Arm 2
5 mg/kg PRO 140, one IV dose (N=10)
Drug: PRO 140
5 mg/kg PRO 140, one IV dose (N=10)
Placebo Comparator: Arm 3
Placebo, one IV dose (N=10)
Drug: Placebo
PBO, one IV dose (N=10)

  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+ T-lymphocyte cell count ≥ 300 cells/mm3 and no documented count < or = 250 cells/mm3
  4. Has not taken any anti-retroviral 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, experimental or approved.
  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: NCT00613379

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: NCT00613379     History of Changes
Other Study ID Numbers: PRO 140 2301, 1 U19 AI066329
Study First Received: January 30, 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

Keywords provided by CytoDyn, Inc.:
HIV
treatment naïve

Additional relevant MeSH terms:
Infection
Communicable Diseases
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 September 22, 2014