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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)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    HIV Positive Subjects
STARTED   10 
COMPLETED   9 
NOT COMPLETED   1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Baseline Measures
   HIV Positive Subjects 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      10 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2  20.0% 
Male      8  80.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      1  10.0% 
Not Hispanic or Latino      9  90.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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% 


  Outcome Measures

1.  Primary:   Number of Grade 3 or Higher Adverse Events   [ Time Frame: From the start of the initial infusion until up to 48 weeks. ]

2.  Secondary:   Subjects Who Met Criteria to Restart Antiretroviral Therapy   [ Time Frame: From Day 3 post initial infusion until up to 28 weeks. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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
e-mail: MSNELLER@niaid.nih.gov


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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