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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00613379
First Posted: February 13, 2008
Last Update Posted: July 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
CytoDyn, Inc.
Results First Submitted: April 12, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Nader Pourhassan
Organization: Cytodyn, Inc.
phone: 360-980-8524
e-mail: npourhassan@cytodyn.com



Responsible Party: CytoDyn, Inc.
ClinicalTrials.gov Identifier: NCT00613379     History of Changes
Other Study ID Numbers: PRO 140 2301
1U19AI066329 ( U.S. NIH Grant/Contract )
First Submitted: January 30, 2008
First Posted: February 13, 2008
Results First Submitted: April 12, 2013
Results First Posted: May 31, 2013
Last Update Posted: July 15, 2016