Is NCT06517693 recruiting in Atlanta, GA?

Yes, NCT06517693 is currently recruiting participants at its Atlanta, GA location. This hiv-1 clinical trial is actively enrolling qualified participants.

How do I join the hiv-1 clinical trial in Atlanta?

To join this clinical trial in Atlanta, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Atlanta clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

HIV-1 Clinical Trial in Atlanta, GA

About This HIV-1 Study in Atlanta

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.

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Who Can Participate

Inclusion 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 study.

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 less than 50 copies/mL from specimens obtained at least four weeks apart with the latest result within four weeks prior to delivery; or

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. Cohorts 1 and 2, BF only:

Per birthing parent's report, intends to breastfeed

Exclusion Criteria

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 interfere with achieving the study objectives.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Atlanta?

Yes, this clinical trial (NCT06517693) has an active research site in Atlanta, GA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

HIV-1 Treatment Options in Atlanta, GA

If you're searching for hiv-1 treatment options in Atlanta, GA, this clinical trial (NCT06517693) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Atlanta research site is actively enrolling participants for this clinical trial. You'll receive care from experienced hiv-1 specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hiv-1 clinical trials near you to find additional studies recruiting in your area.

HIV-1 Clinical Trial in Atlanta, GA

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