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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

January 30, 2008
July 9, 2013
December 2007
August 2008   (final data collection date for primary outcome measure)
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).
Maximum change in viral load following initiation of treatment. [ Time Frame: 59 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00613379 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
PRO 140 by IV Administration in Adults With HIV-1 Infection
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

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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV Infections
  • Drug: PRO 140
    10 mg/kg PRO 140, one IV dose (N=10)
  • Drug: PRO 140
    5 mg/kg PRO 140, one IV dose (N=10)
  • Drug: Placebo
    PBO, one IV dose (N=10)
  • Experimental: Arm 1
    10 mg/kg PRO 140, one IV dose (N=10)
    Intervention: Drug: PRO 140
  • Experimental: Arm 2
    5 mg/kg PRO 140, one IV dose (N=10)
    Intervention: Drug: PRO 140
  • Placebo Comparator: Arm 3
    Placebo, one IV dose (N=10)
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
August 2008
August 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00613379
PRO 140 2301, 1 U19 AI066329
No
CytoDyn, Inc.
CytoDyn, Inc.
Not Provided
Study Director: Stephen Morris, MD, PhD Progenics Pharmaceuticals, Inc.
CytoDyn, Inc.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP