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VRC-HIVMAB060-00-AB (VRC01) in People With Chronic HIV Infection Undergoing Analytical Treatment Interruption

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ClinicalTrials.gov Identifier: NCT02471326
Recruitment Status : Completed
First Posted : June 15, 2015
Results First Posted : October 31, 2017
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV
Intervention Biological: VRC-HIVMAB060-00-AB (VRC01)
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HIV Positive Subjects
Hide Arm/Group Description 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
Period Title: Overall Study
Started 10
Completed 9
Not Completed 1
Arm/Group Title HIV Positive Subjects
Hide Arm/Group Description 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 Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
2
  20.0%
Male
8
  80.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Hispanic or Latino
1
  10.0%
Not Hispanic or Latino
9
  90.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  30.0%
White
6
  60.0%
More than one race
0
   0.0%
Unknown or Not Reported
1
  10.0%
1.Primary Outcome
Title Number of Grade 3 or Higher Adverse Events
Hide Description 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).
Time Frame From the start of the initial infusion until up to 48 weeks.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included all subjects who received at least one infusion of VRC-HIVMAB060-00-AB (VRCO1).
Arm/Group Title HIV Positive Subjects
Hide Arm/Group Description:
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 Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Events
0
2.Secondary Outcome
Title Subjects Who Met Criteria to Restart Antiretroviral Therapy
Hide Description 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).
Time Frame From Day 3 post initial infusion until up to 28 weeks.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included all subjects who received at least one infusion of VRC-HIVMAB060-00-AB (VRCO1).
Arm/Group Title HIV Positive Subjects
Hide Arm/Group Description:
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 Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
10
 100.0%
Time Frame up to 48 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HIV Positive Subjects
Hide Arm/Group Description 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
All-Cause Mortality
HIV Positive Subjects
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
HIV Positive Subjects
Affected / at Risk (%)
Total   1/10 (10.00%) 
Gastrointestinal disorders   
Vomiting  1  1/10 (10.00%) 
1
Term from vocabulary, MedDRA (20.00)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
HIV Positive Subjects
Affected / at Risk (%)
Total   10/10 (100.00%) 
Gastrointestinal disorders   
Nausea  1  1/10 (10.00%) 
General disorders   
Chest pain  1  1/10 (10.00%) 
Influenza like illness  1  1/10 (10.00%) 
Localised oedema  1  1/10 (10.00%) 
Infections and infestations   
Diarrhoea infectious  1  1/10 (10.00%) 
Herpes simplex  1  1/10 (10.00%) 
Nasopharyngitis  1  1/10 (10.00%) 
Tinea versicolour  1  1/10 (10.00%) 
Investigations   
Alanine aminotransferase increased  1  1/10 (10.00%) 
Aspartate aminotransferase increased  1  1/10 (10.00%) 
Blood bicarbonate decreased  1  1/10 (10.00%) 
Blood calcium decreased  1  2/10 (20.00%) 
Blood glucose increased  1  3/10 (30.00%) 
Blood phosphorus decreased  1  2/10 (20.00%) 
Blood sodium decreased  1  1/10 (10.00%) 
Neutrophil count decreased  1  1/10 (10.00%) 
Metabolism and nutrition disorders   
Hyperglycaemia  1  1/10 (10.00%) 
Psychiatric disorders   
Insomnia  1  1/10 (10.00%) 
Reproductive system and breast disorders   
Gynaecomastia  1  1/10 (10.00%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/10 (10.00%) 
Oropharyngeal pain  1  1/10 (10.00%) 
Rhinorrhoea  1  1/10 (10.00%) 
Sinus congestion  1  1/10 (10.00%) 
Skin and subcutaneous tissue disorders   
Rash  1  1/10 (10.00%) 
1
Term from vocabulary, MedDRA (20.00)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Sneller, Michael
Organization: National Institute of Allergy and Infectious Diseases
Phone: +1 301 496 0491
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT02471326     History of Changes
Other Study ID Numbers: 150140
15-I-0140 ( Other Identifier: NIAID IRB )
First Submitted: June 12, 2015
First Posted: June 15, 2015
Results First Submitted: May 12, 2017
Results First Posted: October 31, 2017
Last Update Posted: October 31, 2017