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
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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  
Number of Participants  
[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
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Time Frame No text entered.
Additional Description 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)

Serious Adverse Events
    Arm 1     Arm 2     Arm 3  
Total, serious adverse events        
# participants affected / at risk     0/10 (0.00%)     0/10 (0.00%)     0/11 (0.00%)  




  Other Adverse Events


  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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Clinical Project Manager
Organization: Progenics Pharmaceuticals, Inc.
phone: 914-784-1868
e-mail: trawls@progenics.com


No publications provided


Responsible Party: CytoDyn, Inc.
ClinicalTrials.gov Identifier: NCT00613379     History of Changes
Other Study ID Numbers: PRO 140 2301, 1 U19 AI066329
Study First Received: January 30, 2008
Results First Received: April 12, 2013
Last Updated: July 9, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board