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

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

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

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
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

  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