Trial Outcomes & Findings for PRO 140 by IV Administration in Adults With HIV-1 Infection (NCT NCT00613379)
NCT ID: NCT00613379
Last Updated: 2016-07-15
Results Overview
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 UltraSensitive™ Test (lower limit of detection \[LLD\] = 48 copies/mL).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
59 days
Results posted on
2016-07-15
Participant Flow
Recruitment was from December 2007 to August 2008
Subjects screened up to 12 weeks
Participant milestones
| Measure |
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)
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
11
|
|
Overall Study
COMPLETED
|
10
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PRO 140 by IV Administration in Adults With HIV-1 Infection
Baseline characteristics by cohort
| Measure |
Arm 1
n=10 Participants
10 mg/kg PRO 140, one IV dose (N=10)
|
Arm 2
n=10 Participants
5 mg/kg PRO 140, one IV dose (N=10)
|
Arm 3
n=11 Participants
PBO, one IV dose (N=10)
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
42.5 years
STANDARD_DEVIATION 10.17 • n=5 Participants
|
42 years
STANDARD_DEVIATION 9.88 • n=7 Participants
|
38 years
STANDARD_DEVIATION 11.65 • n=5 Participants
|
40.7 years
STANDARD_DEVIATION 10.48 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
11 participants
n=5 Participants
|
31 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 59 daysPopulation: All randomized subjects who received one dose of study drug were considered intent-to-treat (ITT) subjects and were analyzed for efficacy.
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 UltraSensitive™ Test (lower limit of detection \[LLD\] = 48 copies/mL).
Outcome measures
| Measure |
Arm 1
n=10 Participants
10 mg/kg PRO 140, one IV dose (N=10)
|
Arm 2
n=10 Participants
5 mg/kg PRO 140, one IV dose (N=10)
|
Arm 3
n=11 Participants
PBO, one IV dose (N=10)
|
|---|---|---|---|
|
Maximum Change in Viral Load Following Initiation of Treatment.
|
-1.67 Log10copies HIV-1 RNA/mL
Standard Error 0.639
|
-1.83 Log10copies HIV-1 RNA/mL
Standard Error 0.229
|
-0.32 Log10copies HIV-1 RNA/mL
Standard Error 0.244
|
Adverse Events
Arm 1
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm 2
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Arm 3
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1
n=10 participants at risk
10 mg/kg PRO 140, one IV dose (N=10)
|
Arm 2
n=10 participants at risk
5 mg/kg PRO 140, one IV dose (N=10)
|
Arm 3
n=11 participants at risk
PBO, one IV dose (N=10)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Cardiac disorders
Bundle branch block left
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/10
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/10
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.00%
0/10
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Anorectal discomfort
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/10
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
18.2%
2/11 • Number of events 2
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
Gastrointestinal disorders
Haemorrhoids
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/10
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
General disorders
Catheter site haematoma
|
0.00%
0/10
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Chest discomfort
|
10.0%
1/10 • Number of events 2
|
0.00%
0/10
|
0.00%
0/11
|
|
General disorders
Chills
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
General disorders
Fatigue
|
0.00%
0/10
|
10.0%
1/10 • Number of events 3
|
0.00%
0/11
|
|
General disorders
Feeling hot
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Malaise
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
General disorders
Oedema peripheral
|
0.00%
0/10
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
Bronchiectasis
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Infections and infestations
Bronchitis
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
Infections and infestations
Candidiasis
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Infections and infestations
Hordeolum
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
Infections and infestations
Oral hairy leukoplakia
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10
|
20.0%
2/10 • Number of events 2
|
9.1%
1/11 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/10
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/10
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/10
|
0.00%
0/10
|
9.1%
1/11 • Number of events 2
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/10
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/10
|
0.00%
0/10
|
18.2%
2/11 • Number of events 2
|
|
Investigations
Blood amylase increased
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Investigations
Blood glucose increased
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Investigations
Echocardiogram normal
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.00%
0/10
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/10
|
10.0%
1/10 • Number of events 2
|
0.00%
0/11
|
|
Investigations
Lipase increased
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/10
|
0.00%
0/10
|
18.2%
2/11 • Number of events 2
|
|
Investigations
QRS axis abnormal
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
Investigations
Syphilis test positive
|
0.00%
0/10
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Investigations
Weight increased
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Investigations
White blood cell count decreased
|
0.00%
0/10
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
2/10 • Number of events 2
|
0.00%
0/10
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/10
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint crepitation
|
0.00%
0/10
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10
|
10.0%
1/10 • Number of events 3
|
0.00%
0/11
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Nervous system disorders
Paraesthesia
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Psychiatric disorders
Depression
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/10
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/10
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
18.2%
2/11 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/10
|
20.0%
2/10 • Number of events 4
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/10
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/10
|
0.00%
0/10
|
9.1%
1/11 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
10.0%
1/10 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10
|
0.00%
0/10
|
27.3%
3/11 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/10
|
0.00%
0/10
|
9.1%
1/11 • Number of events 2
|
|
Social circumstances
Physical assault
|
0.00%
0/10
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER