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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

March 21, 2008
July 9, 2013
March 2008
November 2008   (final data collection date for primary outcome measure)
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).
Maximum change in viral load following initiation of treatment. [ Time Frame: 59 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00642707 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of PRO 140 by Subcutaneous Administration in Adult Subjects With HIV -1 Infection
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

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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • HIV -1 Infection
  • HIV Infections
  • Drug: PRO 140 (humanized monoclonal antibody to CCR5)
  • Drug: Placebo Comparator
  • Active Comparator: Arm 1
    PRO 140 for three single SC doses: Days 1, 8, and 15
    Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5)
  • Active Comparator: Arm 2
    PRO 140 for three single SC doses: Days 1, 8 and 15
    Intervention: 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
    Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5)
  • Placebo Comparator: Arm 4
    PBO for three single SC doses: Days 1, 8 and 15
    Intervention: Drug: Placebo Comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
November 2008
November 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+ 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00642707
PRO 140 2101
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