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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
CytoDyn, Inc.
ClinicalTrials.gov Identifier:
NCT00613379
First received: January 30, 2008
Last updated: June 16, 2016
Last verified: June 2016
Results First Received: April 12, 2013  
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
Condition: HIV Infections
Interventions: Drug: PRO 140
Drug: Placebo

  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 was from December 2007 to August 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects screened up to 12 weeks

Reporting Groups
  Description
Arm 1 10 mg/kg PRO 140, one IV dose (N=10)
Arm 2 5 mg/kg PRO 140, one IV dose (N=10)
Arm 3 PBO, one IV dose (N=10)

Participant Flow:   Overall Study
    Arm 1   Arm 2   Arm 3
STARTED   10   10   11 
COMPLETED   10   10   11 
NOT COMPLETED   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 10 mg/kg PRO 140, one IV dose (N=10)
Arm 2 5 mg/kg PRO 140, one IV dose (N=10)
Arm 3 PBO, one IV dose (N=10)
Total Total of all reporting groups

Baseline Measures
   Arm 1   Arm 2   Arm 3   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   11   31 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   10   10   11   31 
>=65 years   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.5  (10.17)   42  (9.88)   38  (11.65)   40.7  (10.48) 
Gender 
[Units: Participants]
       
Female   0   0   0   0 
Male   10   10   11   31 
Region of Enrollment 
[Units: Participants]
       
United States   10   10   11   31 


  Outcome Measures

1.  Primary:   Maximum Change in Viral Load Following Initiation of Treatment.   [ Time Frame: 59 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information