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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: December 14, 2015
Last verified: December 2015
Results First Received: April 12, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: HIV -1 Infection
HIV Infections
Interventions: Drug: PRO 140 (humanized monoclonal antibody to CCR5)
Drug: Placebo Comparator

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment started March 2008 and ended November 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was a screening period of up to 12 weeks. Subjects had to be infected with CCR5-tropic human immunodeficiency virus type 1 (HIV-1)or they were excluded from the study.

Reporting Groups
  Description
Arm 1 PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15
Arm 2 PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15
Arm 3 PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8
Arm 4 Placebo for three single SC doses: Days 1, 8 and 15

Participant Flow:   Overall Study
    Arm 1   Arm 2   Arm 3   Arm 4
STARTED   11   11   12   10 
COMPLETED   10   11   12   8 
NOT COMPLETED   1   0   0   2 
Adverse Event                0                0                0                2 
Withdrawal by Subject                1                0                0                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm 1 PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15
Arm 2 PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15
Arm 3 PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8
Arm 4 Placebo for three single SC doses: Days 1, 8 and 15
Total Total of all reporting groups

Baseline Measures
   Arm 1   Arm 2   Arm 3   Arm 4   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   11   12   10   44 
Age 
[Units: Participants]
         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   11   11   12   10   44 
>=65 years   0   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.5  (5.13)   41.9  (5.46)   46.4  (8.18)   42.4  (7.44)   42.4  (7.09) 
Gender 
[Units: Participants]
         
Female   1   1   1   1   4 
Male   10   10   11   9   40 
Region of Enrollment 
[Units: Participants]
         
United States   11   11   12   10   44 


  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information