Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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


  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 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)

Other Adverse Events
    Arm 1     Arm 2     Arm 3  
Total, other (not including serious) adverse events        
# participants affected / at risk     8/10     7/10     11/11  
Blood and lymphatic system disorders        
Lymphadenopathy † 1      
# participants affected / at risk     1/10 (10.00%)     0/10 (0.00%)     1/11 (9.09%)  
# events     1     0     1  
Cardiac disorders        
Bundle branch block left † 1      
# participants affected / at risk     1/10 (10.00%)     0/10 (0.00%)     0/11 (0.00%)  
# events     1     0     0  
Eye disorders        
Lacrimation increased † 1      
# participants affected / at risk     0/10 (0.00%)     0/10 (0.00%)     1/11 (9.09%)  
# events     0     0     1  
Retinal haemorrhage † 1      
# participants affected / at risk     0/10 (0.00%)     0/10 (0.00%)     1/11 (9.09%)  
# events     0     0     1  
Vision blurred † 1      
# participants affected / at risk     0/10 (0.00%)     0/10 (0.00%)     1/11 (9.09%)  
# events     0     0     1  
Gastrointestinal disorders        
Anorectal discomfort † 1      
# participants affected / at risk     1/10 (10.00%)     0/10 (0.00%)     0/11 (0.00%)  
# events     1     0     0  
Dental caries † 1      
# participants affected / at risk     0/10 (0.00%)     0/10 (0.00%)     1/11 (9.09%)  
# events     0     0     1  
Diarrhoea † 1      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)     2/11 (18.18%)  
# events     0     1     2  
Dry mouth † 1      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)     0/11 (0.00%)  
# events     0     1     0  
Gastrooesophageal reflux disease † 1      
# participants affected / at risk     1/10 (10.00%)     0/10 (0.00%)     0/11 (0.00%)  
# events     1     0     0  
Haemorrhoids † 1      
# participants affected / at risk     1/10 (10.00%)     0/10 (0.00%)     0/11 (0.00%)  
# events     1     0     0  
Mouth ulceration † 1      
# participants affected / at risk     0/10 (0.00%)     0/10 (0.00%)     1/11 (9.09%)  
# events     0     0     1  
Nausea † 1      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)     0/11 (0.00%)  
# events     0     1     0  
General disorders        
Catheter site haematoma † 1      
# participants affected / at risk     0/10 (0.00%)     0/10 (0.00%)     1/11 (9.09%)  
# events     0     0     1  
Chest discomfort † 1      
# participants affected / at risk     1/10 (10.00%)     0/10 (0.00%)     0/11 (0.00%)  
# events     2     0     0  
Chills † 1      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)     0/11 (0.00%)  
# events     0     1     0  
Fatigue † 1      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)     0/11 (0.00%)  
# events     0     3     0  
Feeling hot † 1      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)     1/11 (9.09%)  
# events     0     1     1  
Malaise † 1      
# participants affected / at risk     1/10 (10.00%)     0/10 (0.00%)     0/11 (0.00%)  
# events     1     0     0  
Oedema peripheral † 1      
# participants affected / at risk     0/10 (0.00%)     0/10 (0.00%)     1/11 (9.09%)  
# events     0     0     1  
Infections and infestations        
Bronchiectasis † 1      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)     0/11 (0.00%)  
# events     0     1     0  
Bronchitis † 1      
# participants affected / at risk     1/10 (10.00%)     0/10 (0.00%)     0/11 (0.00%)  
# events     1     0     0  
Candidiasis † 1      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)     0/11 (0.00%)  
# events     0     1     0  
Hepatitis B † 1      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)     0/11 (0.00%)  
# events     0     1     0  
Hordeolum † 1      
# participants affected / at risk     1/10 (10.00%)     0/10 (0.00%)     0/11 (0.00%)  
# events     1     0     0  
Oral hairy leukoplakia † 1      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)     0/11 (0.00%)  
# events     0     1     0  
Upper respiratory tract infection † 1      
# participants affected / at risk     0/10 (0.00%)     2/10 (20.00%)     1/11 (9.09%)  
# events     0     2     1  
Injury, poisoning and procedural complications        
Arthropod bite † 1      
# participants affected / at risk     0/10 (0.00%)     0/10 (0.00%)     1/11 (9.09%)  
# events     0     0     1  
Back injury † 1      
# participants affected / at risk     0/10 (0.00%)     0/10 (0.00%)     1/11 (9.09%)  
# events     0     0     1  
Contusion † 1      
# participants affected / at risk     0/10 (0.00%)     0/10 (0.00%)     1/11 (9.09%)  
# events     0     0     2  
Skin laceration † 1      
# participants affected / at risk     0/10 (0.00%)     0/10 (0.00%)     1/11 (9.09%)  
# events     0     0     1  
Sunburn † 1      
# participants affected / at risk     0/10 (0.00%)     0/10 (0.00%)     2/11 (18.18%)  
# events     0     0     2  
Investigations        
Blood amylase increased † 1      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)     0/11 (0.00%)  
# events     0     1     0  
Blood bicarbonate decreased † 1      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)     0/11 (0.00%)  
# events     0     1     0  
Blood glucose increased † 1      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)     1/11 (9.09%)  
# events     0     1     1  
Blood lactate dehydrogenase increased † 1      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)     0/11 (0.00%)  
# events     0     1     0  
Echocardiogram normal † 1      
# participants affected / at risk     1/10 (10.00%)     0/10 (0.00%)     0/11 (0.00%)  
# events     1     0     0  
Electrocardiogram ST segment elevation † 1      
# participants affected / at risk     0/10 (0.00%)     0/10 (0.00%)     1/11 (9.09%)  
# events     0     0     1  
Electrocardiogram abnormal † 1      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)     0/11 (0.00%)  
# events     0     2     0  
Lipase increased † 1      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)     0/11 (0.00%)  
# events     0     1     0  
Neutrophil count decreased † 1      
# participants affected / at risk     0/10 (0.00%)     0/10 (0.00%)     2/11 (18.18%)  
# events     0     0     2  
QRS axis abnormal † 1      
# participants affected / at risk     1/10 (10.00%)     0/10 (0.00%)     0/11 (0.00%)  
# events     1     0     0  
Syphilis test positive † 1      
# participants affected / at risk     0/10 (0.00%)     0/10 (0.00%)     1/11 (9.09%)  
# events     0     0     1  
Weight increased † 1      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)     0/11 (0.00%)  
# events     0     1     0  
White blood cell count decreased † 1      
# participants affected / at risk     0/10 (0.00%)     0/10 (0.00%)     1/11 (9.09%)  
# events     0     0     1  
Metabolism and nutrition disorders        
Anorexia † 1      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)     0/11 (0.00%)  
# events     0     1     0  
Obesity † 1      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)     0/11 (0.00%)  
# events     0     1     0  
Musculoskeletal and connective tissue disorders        
Arthralgia † 1      
# participants affected / at risk     2/10 (20.00%)     0/10 (0.00%)     0/11 (0.00%)  
# events     2     0     0  
Arthropathy † 1      
# participants affected / at risk     0/10 (0.00%)     0/10 (0.00%)     1/11 (9.09%)  
# events     0     0     1  
Back pain † 1      
# participants affected / at risk     0/10 (0.00%)     0/10 (0.00%)     1/11 (9.09%)  
# events     0     0     1  
Joint crepitation † 1      
# participants affected / at risk     0/10 (0.00%)     0/10 (0.00%)     1/11 (9.09%)  
# events     0     0     1  
Musculoskeletal pain † 1      
# participants affected / at risk     1/10 (10.00%)     0/10 (0.00%)     0/11 (0.00%)  
# events     1     0     0  
Myalgia † 1      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)     0/11 (0.00%)  
# events     0     3     0  
Nervous system disorders        
Dizziness † 1      
# participants affected / at risk     1/10 (10.00%)     1/10 (10.00%)     0/11 (0.00%)  
# events     1     1     0  
Headache † 1      
# participants affected / at risk     2/10 (20.00%)     1/10 (10.00%)     0/11 (0.00%)  
# events     2     1     0  
Hypersomnia † 1      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)     0/11 (0.00%)  
# events     0     1     0  
Paraesthesia † 1      
# participants affected / at risk     1/10 (10.00%)     0/10 (0.00%)     0/11 (0.00%)  
# events     1     0     0  
Psychiatric disorders        
Anxiety † 1      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)     0/11 (0.00%)  
# events     0     1     0  
Depression † 1      
# participants affected / at risk     1/10 (10.00%)     0/10 (0.00%)     1/11 (9.09%)  
# events     1     0     1  
Insomnia † 1      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)     0/11 (0.00%)  
# events     0     1     0  
Renal and urinary disorders        
Proteinuria † 1      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)     0/11 (0.00%)  
# events     0     1     0  
Reproductive system and breast disorders        
Erectile dysfunction † 1      
# participants affected / at risk     0/10 (0.00%)     0/10 (0.00%)     1/11 (9.09%)  
# events     0     0     1  
Gynaecomastia † 1      
# participants affected / at risk     0/10 (0.00%)     0/10 (0.00%)     1/11 (9.09%)  
# events     0     0     1  
Respiratory, thoracic and mediastinal disorders        
Dyspnoea † 1      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)     0/11 (0.00%)  
# events     0     1     0  
Nasal congestion † 1      
# participants affected / at risk     1/10 (10.00%)     0/10 (0.00%)     2/11 (18.18%)  
# events     1     0     2  
Pharyngeal erythema † 1      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)     0/11 (0.00%)  
# events     0     1     0  
Pharyngolaryngeal pain † 1      
# participants affected / at risk     0/10 (0.00%)     2/10 (20.00%)     0/11 (0.00%)  
# events     0     4     0  
Productive cough † 1      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)     0/11 (0.00%)  
# events     0     1     0  
Upper respiratory tract congestion † 1      
# participants affected / at risk     0/10 (0.00%)     0/10 (0.00%)     1/11 (9.09%)  
# events     0     0     1  
Skin and subcutaneous tissue disorders        
Erythema † 1      
# participants affected / at risk     0/10 (0.00%)     0/10 (0.00%)     1/11 (9.09%)  
# events     0     0     2  
Night sweats † 1      
# participants affected / at risk     1/10 (10.00%)     1/10 (10.00%)     0/11 (0.00%)  
# events     1     1     0  
Pruritus † 1      
# participants affected / at risk     0/10 (0.00%)     0/10 (0.00%)     3/11 (27.27%)  
# events     0     0     3  
Rash † 1      
# participants affected / at risk     1/10 (10.00%)     0/10 (0.00%)     0/11 (0.00%)  
# events     1     0     0  
Skin exfoliation † 1      
# participants affected / at risk     0/10 (0.00%)     0/10 (0.00%)     1/11 (9.09%)  
# events     0     0     2  
Social circumstances        
Physical assault † 1      
# participants affected / at risk     0/10 (0.00%)     0/10 (0.00%)     1/11 (9.09%)  
# events     0     0     1  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (11.0)



  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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