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| ID | Type | Description | Link |
|---|---|---|---|
| 1U19AI066329 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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The purpose of this study is:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | 10 mg/kg PRO 140, one IV dose (N=10) |
|
| Arm 2 | Experimental | 5 mg/kg PRO 140, one IV dose (N=10) |
|
| Arm 3 | Placebo Comparator | Placebo, one IV dose (N=10) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRO 140 | Drug | 10 mg/kg PRO 140, one IV dose (N=10) |
| |
| PRO 140 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Change in Viral Load Following Initiation of Treatment. | The primary end point was the maximum change from baseline in viral load following initiation of treatment, defined as HIV-1 copies/mL, measured by the Roche Amplicor HIV-1 Monitor UltraSensitiveâ„¢ Test (lower limit of detection [LLD] = 48 copies/mL). | 59 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Morris, MD, PhD | Progenics Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Progenics Pharmaceuticals, Inc | Tarrytown | New York | 10591 | United States |
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| Label | URL |
|---|---|
| Former Sponsor website | View source |
| Sponsor Website | View source |
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Subjects screened up to 12 weeks
Recruitment was from December 2007 to August 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | 10 mg/kg PRO 140, one IV dose (N=10) |
| FG001 | Arm 2 | 5 mg/kg PRO 140, one IV dose (N=10) |
| FG002 | Arm 3 | PBO, one IV dose (N=10) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | 10 mg/kg PRO 140, one IV dose (N=10) |
| BG001 | Arm 2 | 5 mg/kg PRO 140, one IV dose (N=10) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Change in Viral Load Following Initiation of Treatment. | The primary end point was the maximum change from baseline in viral load following initiation of treatment, defined as HIV-1 copies/mL, measured by the Roche Amplicor HIV-1 Monitor UltraSensitiveâ„¢ Test (lower limit of detection [LLD] = 48 copies/mL). | All randomized subjects who received one dose of study drug were considered intent-to-treat (ITT) subjects and were analyzed for efficacy. | Posted | Mean | Standard Error | Log10copies HIV-1 RNA/mL | 59 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | 10 mg/kg PRO 140, one IV dose (N=10) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nader Pourhassan | Cytodyn, Inc. | 360-980-8524 | npourhassan@cytodyn.com |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C420063 | leronlimab |
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| Drug |
5 mg/kg PRO 140, one IV dose (N=10) |
|
| Placebo | Drug | PBO, one IV dose (N=10) |
|
| BG002 |
| Arm 3 |
PBO, one IV dose (N=10) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Arm 3 | PBO, one IV dose (N=10) |
|
|
| 0 |
| 10 |
| 8 |
| 10 |
| EG001 | Arm 2 | 5 mg/kg PRO 140, one IV dose (N=10) | 0 | 10 | 7 | 10 |
| EG002 | Arm 3 | PBO, one IV dose (N=10) | 0 | 11 | 11 | 11 |
| Bundle branch block left | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Retinal haemorrhage | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Anorectal discomfort | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Catheter site haematoma | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Bronchiectasis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Hepatitis B | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Oral hairy leukoplakia | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Back injury | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Blood amylase increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Blood bicarbonate decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Echocardiogram normal | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Electrocardiogram ST segment elevation | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Electrocardiogram abnormal | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| QRS axis abnormal | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Syphilis test positive | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Joint crepitation | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypersomnia | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (11.0) | Systematic Assessment |
|
| Gynaecomastia | Reproductive system and breast disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Physical assault | Social circumstances | MedDRA (11.0) | Systematic Assessment |
|
Because the study is a multicenter study, the PI(s) can only publish after the aggregate results of all investigators and institutions participating in the study have been published, and the proposed publication is reviewed by Progenics. In the event that Progenics does not publish the results of the study within eighteen months from availability of final study analysis, the PI can publish provided that the proposed publication is reviewed by Progenics.
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |