Status:
COMPLETED
Evaluating the Safety and Pharmacokinetics of VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
Up to 5 years
Phase:
PHASE1
Brief Summary
The purpose of this study was to assess the safety and pharmacokinetics (PK) of three monoclonal antibodies, VRC01, VRC01LS, and VRC07-523LS, in HIV-exposed infants who are at increased risk of mother...
Detailed Description
VRC01, VRC01LS, and VRC07-523LS are anti-HIV neutralizing monoclonal antibodies that may help prevent mother-to-child transmission of HIV. This study enrolled HIV-infected mothers who were at increase...
Eligibility Criteria
Inclusion
- Maternal
- HIV infection
- Greater than or equal to 18 years of age
- Able and willing to provide signed informed consent for herself and her infant
- Maternal
Exclusion
- Prior participation in any HIV-1 vaccine trial
- Receipt of any other active or passive HIV immunotherapy or investigational product during this pregnancy. (Note that administration of Food and Drug Administration \[FDA\]-approved antiretroviral (ARV) drugs when used to treat disease or prevent mother-to-child transmission were not considered investigational.)
- Documented or suspected serious medical illness or immediate life-threatening condition (other than HIV infection) in the mother that may have interfered with the ability to complete study requirements, as judged by the examining clinician
- Infant Inclusion Criteria:
- Born to an HIV-1-infected woman who met all maternal inclusion/exclusion criteria listed above
- Gestational age, by best obstetrical, ultrasound, or infant exam, greater than or equal to 36 weeks
- Birth weight greater than or equal to 2.0 kg
- Allowable infant age at the time of enrollment was dependent on the Dose Group and Cohort:
- Dose Groups 1, 2, 4 and 5 (Cohort 1): Less than 72 hours of age, and anticipated availability to receive VRC immunization at less than 72 hours after birth.
- Dose Groups 3, 4 and 5 (Cohort 2): Less than or equal to 5 days of age, and anticipated availability to receive VRC immunization no more than 5 days after birth.
- At increased risk of HIV acquisition defined as documentation of one or more of the following risk factors:
- Dose Groups 1, 2, 4 and 5 (Cohort 1), only:
- Mother received no antiretroviral therapy (ART) during pregnancy or mother began or reinitiated ART (after an interruption of greater than 14 days), during the third trimester of pregnancy; or
- Mother with any detectable viral replication (HIV RNA above the limit of detection) at last measurement prior to delivery determined within 30 days of delivery; or
- Prolonged rupture of membranes (greater than 12 hours); or
- Mother with documented 2-class resistant HIV infection, which may have included historical documentation of lack of response
- Women who had a documented history of virologic failure while on non-nucleoside reverse transcriptase inhibitors (NNRTIs) but who had no resistance testing at the time of viral failure were considered to have NNRTI-documented resistance.
- Dose Groups 3, 4 and 5 (Cohort 2), only (African sites):
- Mother intended to breastfeed
- Infant
Key Trial Info
Start Date :
June 30 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2021
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT02256631
Start Date
June 30 2015
End Date
December 16 2021
Last Update
February 8 2023
Active Locations (14)
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1
David Geffen School of Medicine at UCLA NICHD CRS
Los Angeles, California, United States, 90095-1752
2
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States, 80045
3
South Florida CDTC Ft Lauderdale NICHD CRS
Fort Lauderdale, Florida, United States, 33316
4
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States, 32209