Trial Outcomes & Findings for VRC-HIVMAB060-00-AB (VRC01) in People With Chronic HIV Infection Undergoing Analytical Treatment Interruption (NCT NCT02471326)
NCT ID: NCT02471326
Last Updated: 2017-10-31
Results Overview
The primary endpoint was the number of grade 3 or higher adverse events, including serious adverse events, that were possibly related to VRC-HIVMAB060-00-AB (VRCO1).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
10 participants
Primary outcome timeframe
From the start of the initial infusion until up to 48 weeks.
Results posted on
2017-10-31
Participant Flow
Participant milestones
| Measure |
HIV Positive Subjects
Drug: VRC-HIVMAB060-00-AB (VRCO1), 40 mg/kg in 100 mL Normal Saline; VRC-HIVMAB060-00-AB (VRCO1) is a potent HIV-specific monoclonal antibody which was given at Baseline, Week 2, and then every 4 weeks for up to a total of 8 doses
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
VRC-HIVMAB060-00-AB (VRC01) in People With Chronic HIV Infection Undergoing Analytical Treatment Interruption
Baseline characteristics by cohort
| Measure |
HIV Positive Subjects
n=10 Participants
Drug: VRC-HIVMAB060-00-AB (VRCO1), 40 mg/kg in 100 mL Normal Saline; VRC-HIVMAB060-00-AB (VRCO1) is a potent HIV-specific monoclonal antibody which was given at Baseline, Week 2, and then every 4 weeks for up to a total of 8 doses
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 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
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 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
|
PRIMARY outcome
Timeframe: From the start of the initial infusion until up to 48 weeks.Population: The analyses included all subjects who received at least one infusion of VRC-HIVMAB060-00-AB (VRCO1).
The primary endpoint was the number of grade 3 or higher adverse events, including serious adverse events, that were possibly related to VRC-HIVMAB060-00-AB (VRCO1).
Outcome measures
| Measure |
HIV Positive Subjects
n=10 Participants
Drug: VRC-HIVMAB060-00-AB (VRCO1), 40 mg/kg in 100 mL Normal Saline; VRC-HIVMAB060-00-AB (VRCO1) is a potent HIV-specific monoclonal antibody which was given at Baseline, Week 2, and then every 4 weeks for up to a total of 8 doses
|
|---|---|
|
Number of Grade 3 or Higher Adverse Events
|
0 Events
|
SECONDARY outcome
Timeframe: From Day 3 post initial infusion until up to 28 weeks.Population: The analyses included all subjects who received at least one infusion of VRC-HIVMAB060-00-AB (VRCO1).
The secondary endpoint was the number of subjects who met protocol defined virologic (sustained HIV RNA \>1000 copies/mL by Abbott HIV RTPCR at 2 consecutive visits), immunologic (a confirmed \>30% decline in CD4 cell count or an absolute CD4 cell count \< 350 cells/mm3), or clinical criteria (HIV-related symptoms) to discontinue VRC01 infusions and restart Antiretroviral Therapy (ART).
Outcome measures
| Measure |
HIV Positive Subjects
n=10 Participants
Drug: VRC-HIVMAB060-00-AB (VRCO1), 40 mg/kg in 100 mL Normal Saline; VRC-HIVMAB060-00-AB (VRCO1) is a potent HIV-specific monoclonal antibody which was given at Baseline, Week 2, and then every 4 weeks for up to a total of 8 doses
|
|---|---|
|
Subjects Who Met Criteria to Restart Antiretroviral Therapy
|
10 Participants
|
Adverse Events
HIV Positive Subjects
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HIV Positive Subjects
n=10 participants at risk
Drug: VRC-HIVMAB060-00-AB (VRCO1), 40 mg/kg in 100 mL Normal Saline; VRC-HIVMAB060-00-AB (VRCO1) is a potent HIV-specific monoclonal antibody which was given at Baseline, Week 2, and then every 4 weeks for up to a total of 8 doses
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • up to 48 Weeks
|
Other adverse events
| Measure |
HIV Positive Subjects
n=10 participants at risk
Drug: VRC-HIVMAB060-00-AB (VRCO1), 40 mg/kg in 100 mL Normal Saline; VRC-HIVMAB060-00-AB (VRCO1) is a potent HIV-specific monoclonal antibody which was given at Baseline, Week 2, and then every 4 weeks for up to a total of 8 doses
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • up to 48 Weeks
|
|
General disorders
Chest pain
|
10.0%
1/10 • up to 48 Weeks
|
|
General disorders
Influenza like illness
|
10.0%
1/10 • up to 48 Weeks
|
|
General disorders
Localised oedema
|
10.0%
1/10 • up to 48 Weeks
|
|
Infections and infestations
Diarrhoea infectious
|
10.0%
1/10 • up to 48 Weeks
|
|
Infections and infestations
Herpes simplex
|
10.0%
1/10 • up to 48 Weeks
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
1/10 • up to 48 Weeks
|
|
Infections and infestations
Tinea versicolour
|
10.0%
1/10 • up to 48 Weeks
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • up to 48 Weeks
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • up to 48 Weeks
|
|
Investigations
Blood bicarbonate decreased
|
10.0%
1/10 • up to 48 Weeks
|
|
Investigations
Blood calcium decreased
|
20.0%
2/10 • up to 48 Weeks
|
|
Investigations
Blood glucose increased
|
30.0%
3/10 • up to 48 Weeks
|
|
Investigations
Blood phosphorus decreased
|
20.0%
2/10 • up to 48 Weeks
|
|
Investigations
Blood sodium decreased
|
10.0%
1/10 • up to 48 Weeks
|
|
Investigations
Neutrophil count decreased
|
10.0%
1/10 • up to 48 Weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.0%
1/10 • up to 48 Weeks
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10 • up to 48 Weeks
|
|
Reproductive system and breast disorders
Gynaecomastia
|
10.0%
1/10 • up to 48 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • up to 48 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.0%
1/10 • up to 48 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.0%
1/10 • up to 48 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
10.0%
1/10 • up to 48 Weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • up to 48 Weeks
|
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