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

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ClinicalTrials.gov Identifier: NCT00642707
Recruitment Status : Completed
First Posted : March 25, 2008
Results First Posted : May 31, 2013
Last Update Posted : January 14, 2016
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: HIV -1 Infection
HIV Infections
Interventions: Drug: PRO 140 (humanized monoclonal antibody to CCR5)
Drug: Placebo Comparator

  Participant Flow


  Baseline Characteristics

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 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 
Overall Participants Analyzed 
[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

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