Trial Outcomes & Findings for Combination Therapy With 3BNC117 and 10-1074 in HIV-Infected Individuals (NCT NCT03571204)
NCT ID: NCT03571204
Last Updated: 2022-02-09
Results Overview
Participants with grade 3 or higher adverse events (AE), including serious adverse advents. AE severity was graded according to the Division of Aids Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.1, July, 2017
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
29 months
Results posted on
2022-02-09
Participant Flow
of 27 participants consented, 6 participants were screen failure so did not start the actual study.
Participant milestones
| Measure |
Group 1: ART Prior to 3BNC117 + 10-1074 in HIV-1 Subject
Subjects who began anti-retroviral therapy (ART) during primary HIV-1 infection within 12 weeks of diagnosis. ART was stopped after study day 3 and were given 3BNC117 and 10-1074 intravenously. Both 3BNC117 and 10-1074 were administered at 30 mg/kg dose level in separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions of 3BNC117 and 10-1074 at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
|
Group 1: ART Prior to Placebo Treatment in HIV-1 Subject
Subjects who began anti-retroviral therapy (ART) during primary HIV-1 infection within 12 weeks of diagnosis. ART was stopped after study day 3 and were given normal saline intravenously. Subjects received two separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
|
Group 2: 3BNC117 + 10-1074 in HIV-1 Subject
Subjects who were not on anti-retroviral therapy (ART) during primary HIV-1 infection within the past 2 years. Subjects were given 3BNC117 and 10-1074 intravenously. Both 3BNC117 and 10-1074 were administered at 30 mg/kg dose level in separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions of 3BNC117 and 10-1074 at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
5
|
|
Overall Study
COMPLETED
|
7
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
Reasons for withdrawal
| Measure |
Group 1: ART Prior to 3BNC117 + 10-1074 in HIV-1 Subject
Subjects who began anti-retroviral therapy (ART) during primary HIV-1 infection within 12 weeks of diagnosis. ART was stopped after study day 3 and were given 3BNC117 and 10-1074 intravenously. Both 3BNC117 and 10-1074 were administered at 30 mg/kg dose level in separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions of 3BNC117 and 10-1074 at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
|
Group 1: ART Prior to Placebo Treatment in HIV-1 Subject
Subjects who began anti-retroviral therapy (ART) during primary HIV-1 infection within 12 weeks of diagnosis. ART was stopped after study day 3 and were given normal saline intravenously. Subjects received two separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
|
Group 2: 3BNC117 + 10-1074 in HIV-1 Subject
Subjects who were not on anti-retroviral therapy (ART) during primary HIV-1 infection within the past 2 years. Subjects were given 3BNC117 and 10-1074 intravenously. Both 3BNC117 and 10-1074 were administered at 30 mg/kg dose level in separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions of 3BNC117 and 10-1074 at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
|
|---|---|---|---|
|
Overall Study
Stopped due to COVID-19 pandemic
|
1
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
Baseline Characteristics
Combination Therapy With 3BNC117 and 10-1074 in HIV-Infected Individuals
Baseline characteristics by cohort
| Measure |
Group 1: ART Prior to 3BNC117 + 10-1074 in HIV-1 Subject
n=8 Participants
Subjects who began anti-retroviral therapy (ART) during primary HIV-1 infection within 12 weeks of diagnosis. ART was stopped after study day 3 and were given 3BNC117 and 10-1074 intravenously. Both 3BNC117 and 10-1074 were administered at 30 mg/kg dose level in separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions of 3BNC117 and 10-1074 at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
|
Group 1: ART Prior to Placebo Treatment in HIV-1 Subject
n=8 Participants
Subjects who began anti-retroviral therapy (ART) during primary HIV-1 infection within 12 weeks of diagnosis. ART was stopped after study day 3 and were given normal saline intravenously. Subjects received two separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
|
Group 2: 3BNC117 + 10-1074 in HIV-1 Subject
n=5 Participants
Subjects who were not on anti-retroviral therapy (ART) during primary HIV-1 infection within the past 2 years. Subjects were given 3BNC117 and 10-1074 intravenously. Both 3BNC117 and 10-1074 were administered at 30 mg/kg dose level in separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions of 3BNC117 and 10-1074 at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
|
Total
n=21 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
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
21 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
|
|
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
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 29 monthsPopulation: Participants who started the study
Participants with grade 3 or higher adverse events (AE), including serious adverse advents. AE severity was graded according to the Division of Aids Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.1, July, 2017
Outcome measures
| Measure |
Group 1: ART Prior to 3BNC117 + 10-1074 in HIV-1 Subject
n=8 Participants
Subjects who began anti-retroviral therapy (ART) during primary HIV-1 infection within 12 weeks of diagnosis. ART was stopped after study day 3 and were given 3BNC117 and 10-1074 intravenously. Both 3BNC117 and 10-1074 were administered at 30 mg/kg dose level in separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions of 3BNC117 and 10-1074 at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
|
Group 1: ART Prior to Placebo Treatment in HIV-1 Subject
n=8 Participants
Subjects who began anti-retroviral therapy (ART) during primary HIV-1 infection within 12 weeks of diagnosis. ART was stopped after study day 3 and were given normal saline intravenously. Subjects received two separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
|
Group 2: 3BNC117 + 10-1074 in HIV-1 Subject
n=5 Participants
Subjects who were not on anti-retroviral therapy (ART) during primary HIV-1 infection within the past 2 years. Subjects were given 3BNC117 and 10-1074 intravenously. Both 3BNC117 and 10-1074 were administered at 30 mg/kg dose level in separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions of 3BNC117 and 10-1074 at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
|
|---|---|---|---|
|
Participants With Grade 3 or Higher Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 28 weeksPopulation: Participants who initiated anti-retroviral treatment interruption (ATI). Two participants did not participate in ATI. One participant deviated from the protocol and was lost to follow-up.
Difference between the treatment and placebo arms in the number of participants who experienced rebound of plasma viremia and met criteria to restart ART prior to study week 28.
Outcome measures
| Measure |
Group 1: ART Prior to 3BNC117 + 10-1074 in HIV-1 Subject
n=7 Participants
Subjects who began anti-retroviral therapy (ART) during primary HIV-1 infection within 12 weeks of diagnosis. ART was stopped after study day 3 and were given 3BNC117 and 10-1074 intravenously. Both 3BNC117 and 10-1074 were administered at 30 mg/kg dose level in separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions of 3BNC117 and 10-1074 at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
|
Group 1: ART Prior to Placebo Treatment in HIV-1 Subject
n=7 Participants
Subjects who began anti-retroviral therapy (ART) during primary HIV-1 infection within 12 weeks of diagnosis. ART was stopped after study day 3 and were given normal saline intravenously. Subjects received two separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
|
Group 2: 3BNC117 + 10-1074 in HIV-1 Subject
Subjects who were not on anti-retroviral therapy (ART) during primary HIV-1 infection within the past 2 years. Subjects were given 3BNC117 and 10-1074 intravenously. Both 3BNC117 and 10-1074 were administered at 30 mg/kg dose level in separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions of 3BNC117 and 10-1074 at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
|
|---|---|---|---|
|
Participants Who Experienced Rebound of Plasma Viremia
|
0 Participants
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: 28 weeksPopulation: Participants who started intravenous infusion therapy
Participants who achieved suppression of viremia to \<40 copies/ml by study week 28
Outcome measures
| Measure |
Group 1: ART Prior to 3BNC117 + 10-1074 in HIV-1 Subject
n=5 Participants
Subjects who began anti-retroviral therapy (ART) during primary HIV-1 infection within 12 weeks of diagnosis. ART was stopped after study day 3 and were given 3BNC117 and 10-1074 intravenously. Both 3BNC117 and 10-1074 were administered at 30 mg/kg dose level in separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions of 3BNC117 and 10-1074 at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
|
Group 1: ART Prior to Placebo Treatment in HIV-1 Subject
Subjects who began anti-retroviral therapy (ART) during primary HIV-1 infection within 12 weeks of diagnosis. ART was stopped after study day 3 and were given normal saline intravenously. Subjects received two separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
|
Group 2: 3BNC117 + 10-1074 in HIV-1 Subject
Subjects who were not on anti-retroviral therapy (ART) during primary HIV-1 infection within the past 2 years. Subjects were given 3BNC117 and 10-1074 intravenously. Both 3BNC117 and 10-1074 were administered at 30 mg/kg dose level in separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions of 3BNC117 and 10-1074 at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
|
|---|---|---|---|
|
Participants Who Achieved Suppression of Viremia
|
2 Participants
|
—
|
—
|
Adverse Events
Group 1: ART Prior to 3BNC117 + 10-1074 in HIV-1 Subject
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 1: ART Prior to Placebo Treatment in HIV-1 Subject
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 2: 3BNC117 + 10-1074 in HIV-1 Subject
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: ART Prior to 3BNC117 + 10-1074 in HIV-1 Subject
n=8 participants at risk
Subjects who began anti-retroviral therapy (ART) during primary HIV-1 infection within 12 weeks of diagnosis. ART was stopped after study day 3 and were given 3BNC117 and 10-1074 intravenously. Both 3BNC117 and 10-1074 were administered at 30 mg/kg dose level in separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions of 3BNC117 and 10-1074 at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
|
Group 1: ART Prior to Placebo Treatment in HIV-1 Subject
n=8 participants at risk
Subjects who began anti-retroviral therapy (ART) during primary HIV-1 infection within 12 weeks of diagnosis. ART was stopped after study day 3 and were given normal saline intravenously. Subjects received two separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
|
Group 2: 3BNC117 + 10-1074 in HIV-1 Subject
n=5 participants at risk
Subjects who were not on anti-retroviral therapy (ART) during primary HIV-1 infection within the past 2 years. Subjects were given 3BNC117 and 10-1074 intravenously. Both 3BNC117 and 10-1074 were administered at 30 mg/kg dose level in separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions of 3BNC117 and 10-1074 at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
|
|---|---|---|---|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/8 • 29 months
|
0.00%
0/8 • 29 months
|
20.0%
1/5 • 29 months
|
Other adverse events
| Measure |
Group 1: ART Prior to 3BNC117 + 10-1074 in HIV-1 Subject
n=8 participants at risk
Subjects who began anti-retroviral therapy (ART) during primary HIV-1 infection within 12 weeks of diagnosis. ART was stopped after study day 3 and were given 3BNC117 and 10-1074 intravenously. Both 3BNC117 and 10-1074 were administered at 30 mg/kg dose level in separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions of 3BNC117 and 10-1074 at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
|
Group 1: ART Prior to Placebo Treatment in HIV-1 Subject
n=8 participants at risk
Subjects who began anti-retroviral therapy (ART) during primary HIV-1 infection within 12 weeks of diagnosis. ART was stopped after study day 3 and were given normal saline intravenously. Subjects received two separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
|
Group 2: 3BNC117 + 10-1074 in HIV-1 Subject
n=5 participants at risk
Subjects who were not on anti-retroviral therapy (ART) during primary HIV-1 infection within the past 2 years. Subjects were given 3BNC117 and 10-1074 intravenously. Both 3BNC117 and 10-1074 were administered at 30 mg/kg dose level in separate bags of 250 mL normal saline in sequential administration. Subjects received 8 infusions of 3BNC117 and 10-1074 at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy was 24 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymph node pain
|
12.5%
1/8 • 29 months
|
0.00%
0/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/8 • 29 months
|
0.00%
0/8 • 29 months
|
20.0%
1/5 • 29 months
|
|
Eye disorders
Chalazion
|
0.00%
0/8 • 29 months
|
12.5%
1/8 • 29 months
|
20.0%
1/5 • 29 months
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/8 • 29 months
|
0.00%
0/8 • 29 months
|
20.0%
1/5 • 29 months
|
|
Eye disorders
Vision blurred
|
12.5%
1/8 • 29 months
|
0.00%
0/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
12.5%
1/8 • 29 months
|
0.00%
0/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/8 • 29 months
|
0.00%
0/8 • 29 months
|
20.0%
1/5 • 29 months
|
|
General disorders
Chills
|
25.0%
2/8 • 29 months
|
0.00%
0/8 • 29 months
|
20.0%
1/5 • 29 months
|
|
General disorders
Fatigue
|
0.00%
0/8 • 29 months
|
0.00%
0/8 • 29 months
|
20.0%
1/5 • 29 months
|
|
General disorders
Infusion site extravasation
|
0.00%
0/8 • 29 months
|
12.5%
1/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
General disorders
Pain
|
0.00%
0/8 • 29 months
|
12.5%
1/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
General disorders
Pyrexia
|
12.5%
1/8 • 29 months
|
0.00%
0/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
Infections and infestations
Abscess oral
|
0.00%
0/8 • 29 months
|
0.00%
0/8 • 29 months
|
20.0%
1/5 • 29 months
|
|
Infections and infestations
Acute sinusitis
|
12.5%
1/8 • 29 months
|
0.00%
0/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
Infections and infestations
Bronchitis
|
12.5%
1/8 • 29 months
|
0.00%
0/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
Infections and infestations
Chlamydial infection
|
12.5%
1/8 • 29 months
|
12.5%
1/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
Infections and infestations
Clostridium difficile infection
|
12.5%
1/8 • 29 months
|
0.00%
0/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/8 • 29 months
|
25.0%
2/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
Infections and infestations
Nasopharyngitis
|
37.5%
3/8 • 29 months
|
25.0%
2/8 • 29 months
|
20.0%
1/5 • 29 months
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/8 • 29 months
|
12.5%
1/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
Infections and infestations
Rash pustular
|
0.00%
0/8 • 29 months
|
12.5%
1/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
1/8 • 29 months
|
25.0%
2/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
2/8 • 29 months
|
12.5%
1/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
Investigations
Amylase increased
|
12.5%
1/8 • 29 months
|
0.00%
0/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
2/8 • 29 months
|
12.5%
1/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/8 • 29 months
|
25.0%
2/8 • 29 months
|
20.0%
1/5 • 29 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/8 • 29 months
|
12.5%
1/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
Investigations
Blood calcium decreased
|
0.00%
0/8 • 29 months
|
0.00%
0/8 • 29 months
|
20.0%
1/5 • 29 months
|
|
Investigations
Blood creatine phosphokinase increased
|
12.5%
1/8 • 29 months
|
12.5%
1/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
Investigations
Blood creatinine increased
|
12.5%
1/8 • 29 months
|
12.5%
1/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
Investigations
Blood glucose increased
|
75.0%
6/8 • 29 months
|
12.5%
1/8 • 29 months
|
60.0%
3/5 • 29 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/8 • 29 months
|
12.5%
1/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
Investigations
Blood phosphorus decreased
|
50.0%
4/8 • 29 months
|
25.0%
2/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
Investigations
Blood potassium decreased
|
0.00%
0/8 • 29 months
|
12.5%
1/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
Investigations
Blood sodium decreased
|
0.00%
0/8 • 29 months
|
0.00%
0/8 • 29 months
|
40.0%
2/5 • 29 months
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/8 • 29 months
|
12.5%
1/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/8 • 29 months
|
0.00%
0/8 • 29 months
|
20.0%
1/5 • 29 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • 29 months
|
0.00%
0/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
1/8 • 29 months
|
0.00%
0/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • 29 months
|
12.5%
1/8 • 29 months
|
20.0%
1/5 • 29 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/8 • 29 months
|
12.5%
1/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
Psychiatric disorders
Anxiety
|
12.5%
1/8 • 29 months
|
0.00%
0/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • 29 months
|
0.00%
0/8 • 29 months
|
20.0%
1/5 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/8 • 29 months
|
0.00%
0/8 • 29 months
|
20.0%
1/5 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
1/8 • 29 months
|
0.00%
0/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/8 • 29 months
|
12.5%
1/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • 29 months
|
12.5%
1/8 • 29 months
|
0.00%
0/5 • 29 months
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/8 • 29 months
|
0.00%
0/8 • 29 months
|
20.0%
1/5 • 29 months
|
Additional Information
Sneller, Michael
National Institute of Allergy and Infectious Diseases
Phone: +1 301 496 0491
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place