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Tests treatment safety and results for HIV-1
Official title Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1
ClinicalTrials.gov ID: NCT06517693
What this study is testing
What is PGT121.414.LS?
PGT121.414.LS is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hiv-1.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of the potent, broadly neutralizing anti-HIV monoclonal antibodies (mAb) PGT121.414.LS alone and in combination with VRC07-523LS soon after birth in infants exposed to HIV-1.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 72. Healthy volunteers may be eligible.
You may be able to join if
- Birthing parent is of legal age or circumstance to provide independent informed consent and is willing and able to provide written informed consent...
- Birthing parent has confirmed HIV-1 infection based on positive test results from two samples collected from two separate blood collection tubes.
- Infant was singleton or twin.
- Infant's gestational age at birth was at least 36 weeks.
- At birth, infant's weight was at least 2 kg.
You likely can't join if
- Birthing parent has received any investigational product during this pregnancy.
- Infant has received any active or passive HIV immunotherapy or any investigational product.
- At entry, infant with a documented positive HIV Nucleic Acid Test (NAT) result.
- Birthing parent or infant has any condition that, in the opinion of the site investigator or designee, would make participation in the study unsafe...
See the full eligibility criteria
- Birthing parent is of legal age or circumstance to provide independent informed consent and is willing and able to provide written informed consent for themselves and permission for their infant's participation in this...
- Birthing parent has confirmed HIV-1 infection based on positive test results from two samples collected from two separate blood collection tubes.
- Infant was singleton or twin.
- Infant's gestational age at birth was at least 36 weeks.
- At birth, infant's weight was at least 2 kg.
- At entry, infant is less than 72 hours of age and is anticipated to receive study product within 72 hours after birth.
- At screening, infant has the following laboratory test results:
- Hemoglobin, normal or grade 1 (≥13 g/dL or ≥8.05 mmol/L)
- Platelets, normal or grade 1 (≥100,000 cells/mm3 or ≥100.000 x10\^9 cells/L)
- Absolute neutrophil count (ANC), normal or grade 1
- ≤24 hours old (≥4,000 cells/mm3 or ≥4.000 x10\^9 cells/L)
- \>24 hours old (≥1,250 cells/mm3 or ≥1.250 x10\^9 cells/L)
- Alanine transaminase (ALT), normal (\<1.25 x ULN)
- At entry, infant is generally healthy as determined by the site investigator based on review of all available medical history information and physical examination findings.
- Cohorts 1 and 2, Strata BF only: At entry, infant is breastfeeding or the birthing parent has indicated an intention to initiate breastfeeding.
- Cohorts 1 and 2, Strata FF, only: At entry, infant is not breastfeeding and the birthing parent has indicated no intention to breastfeed.
- At entry, infant is at increased risk of HIV acquisition. Cohorts 1 and 2, Strata FF only:
- Birthing parent had acute HIV during this pregnancy; or
- Birthing parent with detectable viral replication (plasma HIV RNA results at least 50 copies/mL) during pregnancy who did not have confirmed viral suppression, defined as at least two consecutive plasma HIV RNA results...
- Birthing parent not receiving appropriate ART for at least two weeks, with any part of the two-week period occurring within four weeks prior to delivery, based on birthing parent's report or available medical records...
- Per birthing parent's report, intends to breastfeed
- Birthing parent has received any investigational product during this pregnancy.
- Infant has received any active or passive HIV immunotherapy or any investigational product.
- At entry, infant with a documented positive HIV Nucleic Acid Test (NAT) result.
- Birthing parent or infant has any condition that, in the opinion of the site investigator or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Aurora, Colorado, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- The Bronx, New York, United States
- Memphis, Tennessee, United States
- Houston, Texas, United States
- Rio de Janeiro, Brazil
- Kericho, Kenya
- San Juan, Puerto Rico
- Cape Town, Parrow Valley, South Africa
- Harare, Zimbabwe
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 72 hours. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Aurora, Colorado, United States; Jacksonville, Florida, United States; Miami, Florida, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.