Trial Outcomes & Findings for 3BNC117-LS and 10-1074-LS in Viremic HIV-infected Individuals (NCT NCT04250636)

NCT ID: NCT04250636

Last Updated: 2023-06-26

Results Overview

The number of participants with treatment-related solicited and unsolicited grade 3 and serious adverse events (including confirmed laboratory abnormalities).

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 6 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2023-06-26

Participant Flow

Open-label, sequential enrollment

Participant milestones

Measure	Study Participants HIV-infected individuals, off ART, and with plasma HIV-1 RNA levels between 500 and 100,000 copies/ml by standard assays. Study participants will receive a single intravenous infusion of 3BNC117-LS and a single infusion of 10-1074-LS. The antibodies will be administered sequentially and dosed at 30 mg/kg.
Overall Study STARTED	6
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Study Participants HIV-infected individuals, off ART, and with plasma HIV-1 RNA levels between 500 and 100,000 copies/ml by standard assays. Study participants will receive a single intravenous infusion of 3BNC117-LS and a single infusion of 10-1074-LS. The antibodies will be administered sequentially and dosed at 30 mg/kg.
Overall Study Lost to Follow-up	2

Baseline Characteristics

3BNC117-LS and 10-1074-LS in Viremic HIV-infected Individuals

Baseline characteristics by cohort

Measure	Study Participants n=6 Participants HIV-infected individuals, off ART, and with plasma HIV-1 RNA levels between 500 and 100,000 copies/ml by standard assays. Study participants will receive a single intravenous infusion of 3BNC117-LS and a single infusion of 10-1074-LS. The antibodies will be administered sequentially and dosed at 30 mg/kg.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	35.8 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

The number of participants with treatment-related solicited and unsolicited grade 3 and serious adverse events (including confirmed laboratory abnormalities).

Outcome measures

Measure	Study Participants n=6 Participants HIV-infected individuals, off ART, and with plasma HIV-1 RNA levels between 500 and 100,000 copies/ml by standard assays. Study participants will receive a single intravenous infusion of 3BNC117-LS and a single infusion of 10-1074-LS. The antibodies will be administered sequentially and dosed at 30 mg/kg.
Grade 3 and Serious Adverse Events	0 Participants

PRIMARY outcome

Timeframe: 24 weeks

Peak concentration of 3BNC117-LS and 10-1074-LS when administered intravenously and in combination to viremic HIV-infected individuals.

Outcome measures

Measure	Study Participants n=6 Participants HIV-infected individuals, off ART, and with plasma HIV-1 RNA levels between 500 and 100,000 copies/ml by standard assays. Study participants will receive a single intravenous infusion of 3BNC117-LS and a single infusion of 10-1074-LS. The antibodies will be administered sequentially and dosed at 30 mg/kg.
Peak Concentration 3BNC117-LS	719.83 mcg/ml Standard Deviation 77.62
Peak Concentration 10-1074-LS	915.15 mcg/ml Standard Deviation 207.18

PRIMARY outcome

Timeframe: 24 weeks

Half-life of 3BNC117-LS and 10-1074-LS when administered intravenously and in combination to viremic HIV-infected individuals.

Outcome measures

Measure	Study Participants n=6 Participants HIV-infected individuals, off ART, and with plasma HIV-1 RNA levels between 500 and 100,000 copies/ml by standard assays. Study participants will receive a single intravenous infusion of 3BNC117-LS and a single infusion of 10-1074-LS. The antibodies will be administered sequentially and dosed at 30 mg/kg.
Half-life 3BNC117-LS	41.63 days Standard Deviation 11.71
Half-life 10-1074-LS	47.62 days Standard Deviation 15.38

PRIMARY outcome

Timeframe: 24 weeks

Area under curve of 3BNC117-LS and 10-1074-LS when administered intravenously and in combination to viremic HIV-infected individuals.

Outcome measures

Measure	Study Participants n=6 Participants HIV-infected individuals, off ART, and with plasma HIV-1 RNA levels between 500 and 100,000 copies/ml by standard assays. Study participants will receive a single intravenous infusion of 3BNC117-LS and a single infusion of 10-1074-LS. The antibodies will be administered sequentially and dosed at 30 mg/kg.
Area Under Curve 10-1074-LS	34539.92 (mcg x day)/mL Standard Deviation 34539.92
Area Under Curve 3BNC117-LS	13965.98 (mcg x day)/mL Standard Deviation 2922.99

PRIMARY outcome

Timeframe: 4 weeks

Maximum decline in plasma HIV-1 RNA level after 3BNC117-LS plus 10-1074-LS intravenous infusions in viremic HIV-infected individuals through week 4 after infusions.

Outcome measures

Measure	Study Participants n=6 Participants HIV-infected individuals, off ART, and with plasma HIV-1 RNA levels between 500 and 100,000 copies/ml by standard assays. Study participants will receive a single intravenous infusion of 3BNC117-LS and a single infusion of 10-1074-LS. The antibodies will be administered sequentially and dosed at 30 mg/kg.
Maximum Decline in Plasma HIV-1 RNA Level	1.79 log 10 HIV-1-RNA copies/ml Interval 1.1 to 2.4

SECONDARY outcome

Timeframe: 24 weeks

Number of individuals with treatment-induced anti-drug antibodies against each mAb and magnitude of the response.

Outcome measures

Measure	Study Participants n=6 Participants HIV-infected individuals, off ART, and with plasma HIV-1 RNA levels between 500 and 100,000 copies/ml by standard assays. Study participants will receive a single intravenous infusion of 3BNC117-LS and a single infusion of 10-1074-LS. The antibodies will be administered sequentially and dosed at 30 mg/kg.
Anti-drug Antibodies Anti-3BNC117-LS	0 Participants
Anti-drug Antibodies Anti-10-1074-LS	1 Participants

SECONDARY outcome

Timeframe: 24 weeks

The number of adverse events that occur during the study follow up period after 3BNC117-LS and 10-1074-LS administration.

Outcome measures

Measure	Study Participants n=6 Participants HIV-infected individuals, off ART, and with plasma HIV-1 RNA levels between 500 and 100,000 copies/ml by standard assays. Study participants will receive a single intravenous infusion of 3BNC117-LS and a single infusion of 10-1074-LS. The antibodies will be administered sequentially and dosed at 30 mg/kg.
Adverse Events	5 adverse events

SECONDARY outcome

Timeframe: 24 weeks

The number of confirmed laboratory abnormalities that occur during the study follow up period after 3BNC117-LS and 10-1074-LS administration.

Outcome measures

Measure	Study Participants n=6 Participants HIV-infected individuals, off ART, and with plasma HIV-1 RNA levels between 500 and 100,000 copies/ml by standard assays. Study participants will receive a single intravenous infusion of 3BNC117-LS and a single infusion of 10-1074-LS. The antibodies will be administered sequentially and dosed at 30 mg/kg.
Laboratory Abnormalities	20 graded laboratory abnormalities

Adverse Events

Study Participants

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Study Participants n=6 participants at risk HIV-infected individuals, off ART, and with plasma HIV-1 RNA levels between 500 and 100,000 copies/ml by standard assays. Study participants will receive a single intravenous infusion of 3BNC117-LS and a single infusion of 10-1074-LS. The antibodies will be administered sequentially and dosed at 30 mg/kg.
Infections and infestations Tinea capitis	16.7% 1/6 • Number of events 1 • Adverse events were collected over 24 weeks. Definitions are the definitions of CT.gov
Gastrointestinal disorders Pyrosis	16.7% 1/6 • Number of events 1 • Adverse events were collected over 24 weeks. Definitions are the definitions of CT.gov
Injury, poisoning and procedural complications Penile trauma	16.7% 1/6 • Number of events 1 • Adverse events were collected over 24 weeks. Definitions are the definitions of CT.gov
Immune system disorders Seasonal allergy	16.7% 1/6 • Number of events 1 • Adverse events were collected over 24 weeks. Definitions are the definitions of CT.gov
Infections and infestations COVID-19	16.7% 1/6 • Number of events 1 • Adverse events were collected over 24 weeks. Definitions are the definitions of CT.gov

Additional Information

Marina Caskey

The Rockefeller University

Phone: 2123277396

Email: mcaskey@rockefeller.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place