Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers

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ClinicalTrials.gov Identifier: NCT00110591

Recruitment Status : Completed

First Posted : May 11, 2005

Results First Posted : March 14, 2023

Last Update Posted : March 14, 2023

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Sponsor:

Information provided by (Responsible Party):

CytoDyn, Inc.

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition	HIV Infections
Intervention	Drug: PRO 140
Enrollment	20

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Placebo	PRO 140 Dose 1	PRO 140 Dose 2	PRO 140 Dose 3	PRO 140 Dose 4
Arm/Group Description	Intravenous placebo for PRO 140 ...	0.1 mg/kg PRO 140 by intravenous in...	0.5 mg/kg PRO 140 by intravenous in...	2.0 mg/kg PRO 140 by intravenous in...	5.0 mg/kg PRO 140 by intravenous in...
Arm/Group Description	Intravenous placebo for PRO 140 PRO 140: Monoclonal antibody to CCR5	0.1 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5	0.5 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5	2.0 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5	5.0 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5
Period Title: Overall Study
Started	4	4	4	4	4
Completed	4	4	4	4	4
Not Completed	0	0	0	0	0

Baseline Characteristics

Arm/Group Title		Placebo	PRO 140 Dose 1	PRO 140 Dose 2	PRO 140 Dose 3	PRO 140 Dose 4	Total
Arm/Group Description		Intravenous placebo for PRO 140 ...	0.1 mg/kg PRO 140 by intravenous in...	0.5 mg/kg PRO 140 by intravenous in...	2.0 mg/kg PRO 140 by intravenous in...	5.0 mg/kg PRO 140 by intravenous in...	Total of all reporting groups
Arm/Group Description		Intravenous placebo for PRO 140 PRO 140: Monoclonal antibody to CCR5	0.1 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5	0.5 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5	2.0 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5	5.0 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5	Total of all reporting groups
Overall Number of Baseline Participants		4	4	4	4	4	20
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	4 participants	4 participants	4 participants	4 participants	4 participants	20 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	4 100.0%	4 100.0%	4 100.0%	4 100.0%	4 100.0%	20 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	4 participants	4 participants	4 participants	4 participants	4 participants	20 participants
		26 (7)	34 (13)	30 (12)	22 (2)	21 (2)	27 (9)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	4 participants	4 participants	4 participants	4 participants	4 participants	20 participants
	Female	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Male	4 100.0%	4 100.0%	4 100.0%	4 100.0%	4 100.0%	20 100.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	4 participants	4 participants	4 participants	4 participants	4 participants	20 participants
United States		4	4	4	4	4	20

Outcome Measures

1.Primary Outcome


Title	Safety and Tolerability of PRO 140
Description	[Not Specified]
Description	[Not Specified]
Time Frame	60 days

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Placebo	PRO 140 Dose 1	PRO 140 Dose 2	PRO 140 Dose 3	PRO 140 Dose 4
Arm/Group Description:	Intravenous placebo for PRO 140 ...	0.1 mg/kg PRO 140 by intravenous in...	0.5 mg/kg PRO 140 by intravenous in...	2.0 mg/kg PRO 140 by intravenous in...	5.0 mg/kg PRO 140 by intravenous in...
Arm/Group Description:	Intravenous placebo for PRO 140 PRO 140: Monoclonal antibody to CCR5	0.1 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5	0.5 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5	2.0 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5	5.0 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5
Overall Number of Participants Analyzed	4	4	4	4	4
Measure Type: Number Unit of Measure: number of subjects reporting AEs
	4	4	0	4	3

Adverse Events

Time Frame	Adverse event data was collected over an 18-month period.
Adverse Event Reporting Description	Adverse events were systematically assessed through documented physical examinations, vital sign evaluation, ECGs as well as hematology, uranalysis and chemistry labs. All information is collected on case report forms.

Arm/Group Title	Placebo		PRO 140 Dose 1		PRO 140 Dose 2		PRO 140 Dose 3		PRO 140 Dose 4
Arm/Group Description	Intravenous placebo for PRO 140 ...		0.1 mg/kg PRO 140 by intravenous in...		0.5 mg/kg PRO 140 by intravenous in...		2.0 mg/kg PRO 140 by intravenous in...		5.0 mg/kg PRO 140 by intravenous in...
Arm/Group Description	Intravenous placebo for PRO 140 PRO 140: Monoclonal antibody to CCR5		0.1 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5		0.5 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5		2.0 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5		5.0 mg/kg PRO 140 by intravenous infusion PRO 140: Monoclonal antibody to CCR5
All-Cause Mortality
	Placebo		PRO 140 Dose 1		PRO 140 Dose 2		PRO 140 Dose 3		PRO 140 Dose 4
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--		--/--		--/--
Serious Adverse Events Serious Adverse Events
	Placebo		PRO 140 Dose 1		PRO 140 Dose 2		PRO 140 Dose 3		PRO 140 Dose 4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0.00%)		1/4 (25.00%)		0/4 (0.00%)		0/4 (0.00%)		0/4 (0.00%)
Cardiac disorders
Myocardial infarction ^† 1 [1]	0/4 (0.00%)	0	1/4 (25.00%)	1	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA (6.1) [1] 38 days after receiving PRO 140 (0.1 mg/kg) dose, subject suffered myocardial infarction. This was determined not related to study drug. Subject had severe atherosclerotic disease and history of chest pains.
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Placebo		PRO 140 Dose 1		PRO 140 Dose 2		PRO 140 Dose 3		PRO 140 Dose 4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/4 (100.00%)		4/4 (100.00%)		0/4 (0.00%)		4/4 (100.00%)		3/4 (75.00%)
Cardiac disorders
Fatal Myocardial infarction ^† 1 [1]	0/4 (0.00%)	0	1/4 (25.00%)	1	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0
Gastrointestinal disorders
Abdominal pain upper ^† 1	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0	1/4 (25.00%)	1	0/4 (0.00%)	0
Loose stools ^† 1	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0	1/4 (25.00%)	3	0/4 (0.00%)	0
Nausea ^† 1	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0	1/4 (25.00%)	1	0/4 (0.00%)	0
Injury, poisoning and procedural complications
Joint sprain ^† 1	0/4 (0.00%)	0	1/4 (25.00%)	2	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0
Investigations
high creatine phosphokinase level ^† 1 [2]	2/4 (50.00%)	4	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0	2/4 (50.00%)	3
Alanine aminotransferase increased ^† 1	1/4 (25.00%)	1	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0
Aspartate aminotransferase increased ^† 1	2/4 (50.00%)	4	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0
Blood alkaline phosphatase increased ^† 1	1/4 (25.00%)	1	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0
Electrocardiogram T wave inversion ^† 1	0/4 (0.00%)	0	1/4 (25.00%)	1	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0
Gamma-glutamyltransferase increased ^† 1	1/4 (25.00%)	3	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0
White blood cell count decreased ^† 1	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0	1/4 (25.00%)	1
Musculoskeletal and connective tissue disorders
Back Pain ^† 1	1/4 (25.00%)	2	1/4 (25.00%)	1	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0
Muscle rigidity ^† 1	1/4 (25.00%)	1	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0
Myalgia ^† 1	1/4 (25.00%)	1	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0
Nervous system disorders
Dizziness ^† 1	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0	1/4 (25.00%)	1
Headache ^† 1	1/4 (25.00%)	1	1/4 (25.00%)	1	0/4 (0.00%)	0	2/4 (50.00%)	6	1/4 (25.00%)	1
Paraesthesia ^† 1	0/4 (0.00%)	0	1/4 (25.00%)	1	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	0/4 (0.00%)	0	1/4 (25.00%)	1	0/4 (0.00%)	0	0/4 (0.00%)	0	1/4 (25.00%)	1
Dry Throat ^† 1	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0	1/4 (25.00%)	1	0/4 (0.00%)	0
Epistaxis ^† 1	1/4 (25.00%)	7	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0
Nasal congestion ^† 1	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0	1/4 (25.00%)	1	0/4 (0.00%)	0
Pharyngolaryngeal pain ^† 1	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0	3/4 (75.00%)	3	1/4 (25.00%)	1
Rhinorrhoea ^† 1	0/4 (0.00%)	0	1/4 (25.00%)	1	0/4 (0.00%)	0	1/4 (25.00%)	1	0/4 (0.00%)	0
Sinus congestion ^† 1	0/4 (0.00%)	0	0/4 (0.00%)	0	0/4 (0.00%)	0	1/4 (25.00%)	1	0/4 (0.00%)	0
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA (6.1) [1] This occurred 38 days after administration of the study drug at dose 0.1 mg/kg. [2] one subject (5 mg/kg) had a severe grade 3 AE. There was a grade 3 increased creatine phosphokinase (CPK) test result.

Limitations and Caveats

[Not Specified]

More Information

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.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Joe Meidling
Organization:	CytoDyn, Inc.
Phone:	360-980-8524
EMail:	jmeidling@cytodyn.com

Layout table for additonal information

Responsible Party:	CytoDyn, Inc.
ClinicalTrials.gov Identifier:	NCT00110591
Other Study ID Numbers:	5R44AI046871-04 ( U.S. NIH Grant/Contract ) PRO140-1101 ( Other Identifier: CytoDyn )
First Submitted:	May 10, 2005
First Posted:	May 11, 2005
Results First Submitted:	February 15, 2023
Results First Posted:	March 14, 2023
Last Update Posted:	March 14, 2023

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