Study of PRO 140 by Subcutaneous Administration in Adult Subjects With HIV -1 Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CytoDyn, Inc.
ClinicalTrials.gov Identifier:
NCT00642707
First received: March 21, 2008
Last updated: July 9, 2013
Last verified: July 2013
Results First Received: April 12, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: HIV -1 Infection
HIV Infections
Interventions: Drug: PRO 140 (humanized monoclonal antibody to CCR5)
Drug: Placebo Comparator

  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 started March 2008 and ended November 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was a screening period of up to 12 weeks. Subjects had to be infected with CCR5-tropic human immunodeficiency virus type 1 (HIV-1)or they were excluded from the study.

Reporting Groups
  Description
Arm 1 PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15
Arm 2 PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15
Arm 3 PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8
Arm 4 Placebo for three single SC doses: Days 1, 8 and 15

Participant Flow:   Overall Study
    Arm 1     Arm 2     Arm 3     Arm 4  
STARTED     11     11     12     10  
COMPLETED     10     11     12     8  
NOT COMPLETED     1     0     0     2  
Adverse Event                 0                 0                 0                 2  
Withdrawal by Subject                 1                 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 PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15
Arm 2 PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15
Arm 3 PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8
Arm 4 Placebo for three single SC doses: Days 1, 8 and 15
Total Total of all reporting groups

Baseline Measures
    Arm 1     Arm 2     Arm 3     Arm 4     Total  
Number of Participants  
[units: participants]
  11     11     12     10     44  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     11     11     12     10     44  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  38.5  ± 5.13     41.9  ± 5.46     46.4  ± 8.18     42.4  ± 7.44     42.4  ± 7.09  
Gender  
[units: participants]
         
Female     1     1     1     1     4  
Male     10     10     11     9     40  
Region of Enrollment  
[units: participants]
         
United States     11     11     12     10     44  



  Outcome Measures

1.  Primary:   Maximum Change in Viral Load Following Initiation of Treatment (Viral Load is Defined as HIV-1 Copies/mL and Expressed as log10 Copies/mL).   [ 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
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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: 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: NCT00642707     History of Changes
Other Study ID Numbers: PRO 140 2101
Study First Received: March 21, 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
United States: National Institute of Health