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
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


  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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