Clin2
NCT06517693Possibly a fitRecruiting

HIV antibody safety study for newborns at risk

HIV-1

Treatments studied

Part of Infections clinical trials.

This study tests whether giving a combination of two lab-made antibodies (PGT121.414.LS and VRC07-523LS) to newborns exposed to HIV during pregnancy is safe and how the body processes them. It may help protect infants from getting HIV after birth.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 1
Enrollment
48 people
Ages
Up to 3 days
Study type
Interventional

Who can take part

  • The infant's birth parent has HIV infection and is willing to provide consent.
  • The infant was born at 36 weeks or later, weighing at least 4.4 pounds (2 kg).
  • The infant is less than 72 hours old at the start and will receive the study product within 72 hours of birth.
  • The infant has normal blood counts (hemoglobin, platelets, white blood cells) and liver function.
  • The infant is generally healthy and at higher risk of getting HIV (for example, if the birthing parent had high virus levels or wasn't on HIV medication).

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

Similar studies

Other trials that look related to this one.

NCT02140255Recruiting· Phase 1/Phase 2
Intensive early HIV treatment in newborns to aim for remission

This study gives very early, intensive HIV medicine to infants diagnosed with HIV and follows them closely to see if HIV can go into remission (stop being detectable without ongoing treatment). It may help families understand whether treating right after birth can change a child’s long-term HIV outlook.

La Jolla, California
NCT07637942Not yet recruiting
HIV treatment in pregnancy

This study tests whether a combination of two long-acting HIV medications (cabotegravir and rilpivirine), given as shots every month, is safe and works well for pregnant women who are already taking this treatment. It aims to keep the mother's HIV under control and protect the baby.

La Jolla, California
NCT05674656Recruiting· Phase 1/Phase 2
Testing dolutegravir and rilpivirine in HIV-positive children

This study checks how safe and well two HIV medicines work in children ages 6 to under 12. It also measures drug levels in the body to guide dosing and watch for side effects.

Long Beach, California
NCT07655128Not yet recruiting· Phase 1/Phase 2
Early antibodies for infants with HIV

This study tests whether giving a special antibody treatment to babies living with HIV, shortly after birth, can help their immune system fight the virus better. It aims to improve their long-term health.

NCT06613789Not yet recruiting· Phase 1
HIV vaccine study for babies born to mothers with HIV

This trial tests an experimental vaccine for babies who were exposed to HIV while in the womb but are not infected. Mothers must be living with HIV, on treatment, and deliver by C-section at the study hospital in Soweto.

Soweto, Gauteng
NCT07655141Not yet recruiting· Phase 1/Phase 2
Antibody treatment for infants living with HIV

This trial tests a new antibody medication given as a shot to babies with HIV. It aims to help control the virus and may be an option for infants who are newly diagnosed or starting treatment.

Hear when a new HIV-1 trial opens

We’ll email you when one opens — at most once a week, no account needed, unsubscribe anytime.