Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | PRO 140 for three single SC doses: Days 1, 8, and 15 |
|
| Arm 2 | Active Comparator | PRO 140 for three single SC doses: Days 1, 8 and 15 |
|
| Arm 3 | Active Comparator | PRO 140 for two single SC doses: Days 1 and 15 plus one SC dose of PBO at Day 8 |
|
| Arm 4 | Placebo Comparator | PBO for three single SC doses: Days 1, 8 and 15 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRO 140 (humanized monoclonal antibody to CCR5) | Drug |
| ||
| Placebo Comparator |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Change in Viral Load Following Initiation of Treatment (Viral Load is Defined as HIV-1 Copies/mL and Expressed as log10 Copies/mL). | 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20377413 | Derived | Jacobson JM, Thompson MA, Lalezari JP, Saag MS, Zingman BS, D'Ambrosio P, Stambler N, Rotshteyn Y, Marozsan AJ, Maddon PJ, Morris SA, Olson WC. Anti-HIV-1 activity of weekly or biweekly treatment with subcutaneous PRO 140, a CCR5 monoclonal antibody. J Infect Dis. 2010 May 15;201(10):1481-7. doi: 10.1086/652190. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
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.
Recruitment started March 2008 and ended November 2008
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15 |
| FG001 | Arm 2 | PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15 |
| FG002 | Arm 3 | PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8 |
| FG003 | Arm 4 | Placebo for three single SC doses: Days 1, 8 and 15 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15 |
| BG001 | Arm 2 | PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15 |
| 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 (Viral Load is Defined as HIV-1 Copies/mL and Expressed as log10 Copies/mL). | 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 Deviation | Log10copies/HIV-1 RNA/mL | 59 days |
|
Not provided
Not provided
Not provided
| 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 | PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Meningitis viral | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kush Dhody | CytoDyn, Inc. | 301-956-2536 | kushd@amarexcro.com |
Not provided
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
Not provided
| ID | Term |
|---|---|
| C420063 | leronlimab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| Withdrawal by Subject |
|
| BG002 | Arm 3 | PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8 |
| BG003 | Arm 4 | Placebo for three single SC doses: Days 1, 8 and 15 |
| BG004 | 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 |
|
PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15 |
| OG002 | Arm 3 | PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8 |
| OG003 | Arm 4 | Placebo for three single SC doses: Days 1, 8 and 15 |
|
|
| 0 |
| 11 |
| 9 |
| 11 |
| EG001 | Arm 2 | PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15 | 0 | 11 | 10 | 11 |
| EG002 | Arm 3 | PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8 | 3 | 12 | 11 | 12 |
| EG003 | Arm 4 | Placebo for three single SC doses: Days 1, 8 and 15 | 0 | 10 | 10 | 10 |
| Scrotal abscess | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Anal cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
|
| Tympanic membrane disorder | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dental discomfort | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Faeces pale | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Intestinal mass | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Perianal erythema | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Infusion site erythema | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Infusion site induration | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Infusion site inflammation | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Infusion site pain | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection site discomfort | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection site irritation | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vessel puncture site haematoma | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Chlamydial infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Meningitis viral | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Scrotal abscess | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Subcutaneous abcess | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Syphillis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Tinea cruris | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Urethritis gonococcal | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Vaginitis bacterial | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Chemical poisoning | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Blood pressure diastolic increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Cardiac murmur | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Electrocardiogram abnormal | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Herpes simplex serology positive | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Urine analysis abnormal | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Clubbing | 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 |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Anal cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Anaesthesia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| Drug abuse | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| Stress | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Penile discharge | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Scrotal pain | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nasal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dry skin | 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 hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Skin maceration | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | 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 |