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
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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

Other Adverse Events
    Arm 1     Arm 2     Arm 3     Arm 4  
Total, other (not including serious) adverse events          
# participants affected / at risk     9/11     10/11     11/12     10/10  
Blood and lymphatic system disorders          
Lymphadenopathy † 1        
# participants affected / at risk     3/11 (27.27%)     1/11 (9.09%)     1/12 (8.33%)     0/10 (0.00%)  
# events     4     1     1     0  
Cardiac disorders          
Tachycardia † 1        
# participants affected / at risk     1/11 (9.09%)     0/11 (0.00%)     0/12 (0.00%)     2/10 (20.00%)  
# events     1     0     0     2  
Ear and labyrinth disorders          
Ear pain † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     1/12 (8.33%)     0/10 (0.00%)  
# events     0     0     1     0  
Tympanic membrane disorder † 1        
# participants affected / at risk     0/11 (0.00%)     1/11 (9.09%)     0/12 (0.00%)     0/10 (0.00%)  
# events     0     1     0     0  
Gastrointestinal disorders          
Constipation † 1        
# participants affected / at risk     1/11 (9.09%)     1/11 (9.09%)     1/12 (8.33%)     0/10 (0.00%)  
# events     1     1     1     0  
Dental discomfort † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     1/12 (8.33%)     0/10 (0.00%)  
# events     0     0     1     0  
Diarrhoea † 1        
# participants affected / at risk     1/11 (9.09%)     3/11 (27.27%)     2/12 (16.67%)     0/10 (0.00%)  
# events     1     3     2     0  
Faeces pale † 1        
# participants affected / at risk     1/11 (9.09%)     0/11 (0.00%)     0/12 (0.00%)     0/10 (0.00%)  
# events     1     0     0     0  
Flatulence † 1        
# participants affected / at risk     0/11 (0.00%)     1/11 (9.09%)     0/12 (0.00%)     0/10 (0.00%)  
# events     0     1     0     0  
Gastritis † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     1/12 (8.33%)     0/10 (0.00%)  
# events     0     0     1     0  
Intestinal mass † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     1/12 (8.33%)     0/10 (0.00%)  
# events     0     0     1     0  
Nausea † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     2/12 (16.67%)     0/10 (0.00%)  
# events     0     0     2     0  
Perianal erythema † 1        
# participants affected / at risk     1/11 (9.09%)     0/11 (0.00%)     0/12 (0.00%)     0/10 (0.00%)  
# events     1     0     0     0  
Toothache † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     0/12 (0.00%)     1/10 (10.00%)  
# events     0     0     0     1  
General disorders          
Adverse drug reaction † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     1/12 (8.33%)     0/10 (0.00%)  
# events     0     0     1     0  
Asthenia † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     1/12 (8.33%)     0/10 (0.00%)  
# events     0     0     1     0  
Chills † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     1/12 (8.33%)     0/10 (0.00%)  
# events     0     0     1     0  
Fatigue † 1        
# participants affected / at risk     2/11 (18.18%)     0/11 (0.00%)     1/12 (8.33%)     0/10 (0.00%)  
# events     2     0     1     0  
Infusion site erythema † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     0/12 (0.00%)     1/10 (10.00%)  
# events     0     0     0     1  
Infusion site induration † 1        
# participants affected / at risk     1/11 (9.09%)     2/11 (18.18%)     3/12 (25.00%)     0/10 (0.00%)  
# events     3     5     5     0  
Infusion site inflammation † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     0/12 (0.00%)     1/10 (10.00%)  
# events     0     0     0     1  
Infusion site pain † 1        
# participants affected / at risk     0/11 (0.00%)     1/11 (9.09%)     2/12 (16.67%)     1/10 (10.00%)  
# events     0     1     4     1  
Injection site discomfort † 1        
# participants affected / at risk     1/11 (9.09%)     0/11 (0.00%)     0/12 (0.00%)     0/10 (0.00%)  
# events     1     0     0     0  
Injection site erythema † 1        
# participants affected / at risk     2/11 (18.18%)     0/11 (0.00%)     0/12 (0.00%)     0/10 (0.00%)  
# events     5     0     0     0  
Injection site haemorrhage † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     0/12 (0.00%)     1/10 (10.00%)  
# events     0     0     0     1  
Injection site induration † 1        
# participants affected / at risk     2/11 (18.18%)     1/11 (9.09%)     0/12 (0.00%)     0/10 (0.00%)  
# events     5     1     0     0  
Injection site irritation † 1        
# participants affected / at risk     1/11 (9.09%)     1/11 (9.09%)     1/12 (8.33%)     0/10 (0.00%)  
# events     1     2     1     0  
Injection site pain † 1        
# participants affected / at risk     1/11 (9.09%)     0/11 (0.00%)     1/12 (8.33%)     0/10 (0.00%)  
# events     3     0     1     0  
Injection site reaction † 1        
# participants affected / at risk     0/11 (0.00%)     1/11 (9.09%)     0/12 (0.00%)     1/10 (10.00%)  
# events     0     1     0     1  
Pain † 1        
# participants affected / at risk     0/11 (0.00%)     1/11 (9.09%)     0/12 (0.00%)     1/10 (10.00%)  
# events     0     1     0     1  
Pyrexia † 1        
# participants affected / at risk     0/11 (0.00%)     1/11 (9.09%)     0/12 (0.00%)     0/10 (0.00%)  
# events     0     1     0     0  
Vessel puncture site haematoma † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     0/12 (0.00%)     1/10 (10.00%)  
# events     0     0     0     1  
Infections and infestations          
Chlamydial infection † 1        
# participants affected / at risk     1/11 (9.09%)     0/11 (0.00%)     0/12 (0.00%)     0/10 (0.00%)  
# events     1     0     0     0  
Folliculitis † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     1/12 (8.33%)     0/10 (0.00%)  
# events     0     0     1     0  
Gastroenteritis † 1        
# participants affected / at risk     0/11 (0.00%)     1/11 (9.09%)     0/12 (0.00%)     0/10 (0.00%)  
# events     0     1     0     0  
Herpes simplex † 1        
# participants affected / at risk     1/11 (9.09%)     1/11 (9.09%)     0/12 (0.00%)     0/10 (0.00%)  
# events     1     1     0     0  
Influenza † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     1/12 (8.33%)     0/10 (0.00%)  
# events     0     0     1     0  
Meningitis viral † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     1/12 (8.33%)     0/10 (0.00%)  
# events     0     0     1     0  
Nasopharyngitis † 1        
# participants affected / at risk     1/11 (9.09%)     0/11 (0.00%)     1/12 (8.33%)     0/10 (0.00%)  
# events     1     0     2     0  
Oral herpes † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     0/12 (0.00%)     1/10 (10.00%)  
# events     0     0     0     1  
Respiratory tract infection viral † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     1/12 (8.33%)     0/10 (0.00%)  
# events     0     0     1     0  
Scrotal abscess † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     1/12 (8.33%)     0/10 (0.00%)  
# events     0     0     4     0  
Skin infection † 1        
# participants affected / at risk     0/11 (0.00%)     1/11 (9.09%)     0/12 (0.00%)     0/10 (0.00%)  
# events     0     1     0     0  
Staphylococcal infection † 1        
# participants affected / at risk     0/11 (0.00%)     1/11 (9.09%)     0/12 (0.00%)     0/10 (0.00%)  
# events     0     1     0     0  
Subcutaneous abcess † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     1/12 (8.33%)     0/10 (0.00%)  
# events     0     0     1     0  
Syphillis † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     1/12 (8.33%)     0/10 (0.00%)  
# events     0     0     1     0  
Tinea cruris † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     1/12 (8.33%)     0/10 (0.00%)  
# events     0     0     1     0  
Upper respiratory tract infection † 1        
# participants affected / at risk     0/11 (0.00%)     2/11 (18.18%)     1/12 (8.33%)     0/10 (0.00%)  
# events     0     2     1     0  
Urethritis gonococcal † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     0/12 (0.00%)     1/10 (10.00%)  
# events     0     0     0     1  
Vaginitis bacterial † 1        
# participants affected / at risk     1/11 (9.09%)     0/11 (0.00%)     0/12 (0.00%)     0/10 (0.00%)  
# events     1     0     0     0  
Injury, poisoning and procedural complications          
Arthropod bite † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     0/12 (0.00%)     2/10 (20.00%)  
# events     0     0     0     3  
Chemical poisoning † 1        
# participants affected / at risk     1/11 (9.09%)     0/11 (0.00%)     0/12 (0.00%)     0/10 (0.00%)  
# events     1     0     0     0  
Excoriation † 1        
# participants affected / at risk     1/11 (9.09%)     0/11 (0.00%)     0/12 (0.00%)     0/10 (0.00%)  
# events     1     0     0     0  
Investigations          
Blood creatine phosphokinase increased † 1        
# participants affected / at risk     0/11 (0.00%)     1/11 (9.09%)     0/12 (0.00%)     0/10 (0.00%)  
# events     0     1     0     0  
Blood pressure diastolic increased † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     1/12 (8.33%)     0/10 (0.00%)  
# events     0     0     1     0  
Blood pressure increased † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     1/12 (8.33%)     0/10 (0.00%)  
# events     0     0     5     0  
Cardiac murmur † 1        
# participants affected / at risk     1/11 (9.09%)     0/11 (0.00%)     0/12 (0.00%)     0/10 (0.00%)  
# events     1     0     0     0  
Electrocardiogram abnormal † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     0/12 (0.00%)     1/10 (10.00%)  
# events     0     0     0     1  
Herpes simplex serology positive † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     0/12 (0.00%)     1/10 (10.00%)  
# events     0     0     0     1  
Urine analysis abnormal † 1        
# participants affected / at risk     0/11 (0.00%)     1/11 (9.09%)     0/12 (0.00%)     0/10 (0.00%)  
# events     0     1     0     0  
Weight increased † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     0/12 (0.00%)     1/10 (10.00%)  
# events     0     0     0     1  
Metabolism and nutrition disorders          
Anorexia † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     2/12 (16.67%)     0/10 (0.00%)  
# events     0     0     3     0  
Increased appetite † 1        
# participants affected / at risk     0/11 (0.00%)     1/11 (9.09%)     0/12 (0.00%)     0/10 (0.00%)  
# events     0     1     0     0  
Musculoskeletal and connective tissue disorders          
Arthralgia † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     1/12 (8.33%)     0/10 (0.00%)  
# events     0     0     1     0  
Clubbing † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     0/12 (0.00%)     1/10 (10.00%)  
# events     0     0     0     1  
Musculoskeletal pain † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     1/12 (8.33%)     0/10 (0.00%)  
# events     0     0     1     0  
Myalgia † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     2/12 (16.67%)     0/10 (0.00%)  
# events     0     0     2     0  
Pain in extremity † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     2/12 (16.67%)     0/10 (0.00%)  
# events     0     0     3     0  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)          
Anal cancer stage I † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     1/12 (8.33%)     0/10 (0.00%)  
# events     0     0     1     0  
Lipoma † 1        
# participants affected / at risk     1/11 (9.09%)     0/11 (0.00%)     0/12 (0.00%)     0/10 (0.00%)  
# events     1     0     0     0  
Uterine leiomyoma † 1        
# participants affected / at risk     1/11 (9.09%)     0/11 (0.00%)     0/12 (0.00%)     0/10 (0.00%)  
# events     1     0     0     0  
Nervous system disorders          
Anaesthesia † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     1/12 (8.33%)     0/10 (0.00%)  
# events     0     0     1     0  
Dizziness † 1        
# participants affected / at risk     1/11 (9.09%)     0/11 (0.00%)     0/12 (0.00%)     0/10 (0.00%)  
# events     1     0     0     0  
Headache † 1        
# participants affected / at risk     3/11 (27.27%)     0/11 (0.00%)     2/12 (16.67%)     1/10 (10.00%)  
# events     3     0     2     2  
Sinus headache † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     0/12 (0.00%)     1/10 (10.00%)  
# events     0     0     0     1  
Psychiatric disorders          
Abnormal dreams † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     1/12 (8.33%)     0/10 (0.00%)  
# events     0     0     1     0  
Depression † 1        
# participants affected / at risk     0/11 (0.00%)     1/11 (9.09%)     0/12 (0.00%)     0/10 (0.00%)  
# events     0     1     0     0  
Drug abuse † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     0/12 (0.00%)     1/10 (10.00%)  
# events     0     0     0     1  
Insomnia † 1        
# participants affected / at risk     0/11 (0.00%)     1/11 (9.09%)     1/12 (8.33%)     0/10 (0.00%)  
# events     0     1     1     0  
Stress † 1        
# participants affected / at risk     0/11 (0.00%)     1/11 (9.09%)     0/0 (0.00%)     0/10 (0.00%)  
# events     0     1     0     0  
Renal and urinary disorders          
Chromaturia † 1        
# participants affected / at risk     1/11 (9.09%)     0/11 (0.00%)     0/12 (0.00%)     0/10 (0.00%)  
# events     1     0     0     0  
Penile discharge † 1        
# participants affected / at risk     1/11 (9.09%)     0/11 (0.00%)     0/12 (0.00%)     0/10 (0.00%)  
# events     1     0     0     0  
Scrotal pain † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     1/12 (8.33%)     0/10 (0.00%)  
# events     0     0     2     0  
Respiratory, thoracic and mediastinal disorders          
Epistaxis † 1        
# participants affected / at risk     1/11 (9.09%)     0/11 (0.00%)     0/12 (0.00%)     0/10 (0.00%)  
# events     1     0     0     0  
Nasal congestion † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     0/12 (0.00%)     1/10 (10.00%)  
# events     0     0     0     1  
Nasal oedema † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     1/12 (8.33%)     0/10 (0.00%)  
# events     0     0     1     0  
Rhinitis allergic † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     1/12 (8.33%)     1/10 (10.00%)  
# events     0     0     1     1  
Skin and subcutaneous tissue disorders          
Dermatitis † 1        
# participants affected / at risk     2/11 (18.18%)     0/11 (0.00%)     0/12 (0.00%)     0/10 (0.00%)  
# events     2     0     0     0  
Dry skin † 1        
# participants affected / at risk     0/11 (0.00%)     1/11 (9.09%)     0/12 (0.00%)     0/10 (0.00%)  
# events     0     1     0     0  
Pruritus † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     0/12 (0.00%)     1/10 (10.00%)  
# events     0     0     0     1  
Rash † 1        
# participants affected / at risk     0/11 (0.00%)     1/11 (9.09%)     0/12 (0.00%)     0/10 (0.00%)  
# events     0     1     0     0  
Skin hyperpigmentation † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     0/12 (0.00%)     1/10 (10.00%)  
# events     0     0     0     1  
Skin maceration † 1        
# participants affected / at risk     0/11 (0.00%)     1/11 (9.09%)     0/12 (0.00%)     0/10 (0.00%)  
# events     0     1     0     0  
Urticaria † 1        
# participants affected / at risk     0/11 (0.00%)     1/11 (9.09%)     0/12 (0.00%)     0/10 (0.00%)  
# events     0     1     0     0  
Vascular disorders          
Haematoma † 1        
# participants affected / at risk     0/11 (0.00%)     0/11 (0.00%)     0/12 (0.00%)     1/10 (10.00%)  
# events     0     0     0     1  
Hypertension † 1        
# participants affected / at risk     0/11 (0.00%)     1/11 (9.09%)     1/12 (8.33%)     2/10 (20.00%)  
# events     0     2     1     2  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 11.0



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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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