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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


  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.
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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
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information