A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) During Analytic Treatment Interruption in Participants Living With HIV Who Initiated ART During Acute/Early HIV-1 Infection

Inclusion Criteria

• •Ability and willingness of participant to provide informed consent.
• •Initiation of combination ART within 90 days of acute HIV diagnosis as defined by any of the criteria listed below:
• •* A negative HIV Ab or HIV Ag/Ab Combination Assay and a detectable HIV-1 RNA (qualitative or quantitative) or a subsequently positive Western blot (WB) or equivalent HIV-1 confirmatory assay (e.g. Geenius assay) if no positive HIV-1 RNA test was available.
• •* A positive HIV Ab or HIV Ag/Ab Combination Assay or p24 antigen test and a negative or indeterminate HIV confirmatory/differentiating test with a detectable HIV-1 RNA (qualitative or quantitative).
• •* A positive HIV Ab or HIV-1 RNA or p24 antigen and positive WB or Geenius HIV-1/HIV-2 Supplemental Assay that is negative for p31 band.
• •* Two different rapid HIV tests with discordant results followed by subsequently positive HIV serum antibody and/or HIV-1 RNA tests.
• •* A positive HIV antibody test according to standard criteria obtained within 60 days after an initial negative or indeterminate HIV antibody, antigen, or nucleic acid amplification.
• •For women who are able to become pregnant, negative serum or urine pregnancy test within 48 hours prior to Step 1 entry.
• •All study candidates must agree not to participate in an assisted conception process (e.g., sperm donation, intrauterine insemination, in vitro fertilization) from the screening visit until 12 weeks after the final study visit.
• •Women who can become pregnant and are engaging in sexual activity that could lead to pregnancy must agree to use one highly effective method of contraception from Step 1 entry until 12 weeks after the final study visit.
• •Willingness to use barrier protection (male or female) during sexual activity during ATI and through confirmed viral resuppression.
• •Weight ≥50 kg and ≤150 kg at screening.
• •On stable suppressive ART for at least 12 months prior to Step 1 entry. No known ART interruption for longer than 14 days within 12 months prior to Step 1 entry. No more than two known ART interruptions of a duration between 14 and 60 consecutive days since initiation of ART.
• •ART regimens must contain a protease inhibitor (PI) or integrase strand transfer inhibitor (INSTI) as one of the active drugs in the ART regimen at the time of Step 1 entry.
• •CD4+ cell count of \>450 cells/mL obtained within 60 days prior to Step 1 entry.
• •Within 60 days prior to Step 1 entry, plasma HIV-1 RNA \< 50 copies/mL of plasma.
• •Plasma HIV-1 RNA \<50 copies/mL (or below the assay limit of quantification if the local assay limit of quantification is \>50 copies/mL) since initial viral suppression on ART and for at least 1 year prior to Step 1 entry.
• •Willingness to participate in an ATI.
• •The following laboratory values obtained within 60 days prior to Step 1 entry:
• •* Absolute neutrophil count (ANC) ≥1000 cells/mm\^3
• •* Hemoglobin ≥12.0 g/dL for men and ≥11.0 g/dL for women
• •* Platelet count ≥125,000/mm\^3
• •* Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m\^2 calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) 2021 equation
• •* Total bilirubin \<1.5 x upper limit of normal (ULN)
• •* Aspartate aminotransferase (AST) (SGOT) \<1.5 x ULN
• •* Alanine aminotransferase (ALT) (SGPT) \<1.5 x ULN
• •* Alkaline phosphatase \<1.5 x ULN
• •Hepatitis C virus (HCV) antibody negative result within 60 days prior to Step 1 entry or, for participants who are HCV antibody positive (based on testing performed at any time prior to Step 1 entry), a negative HCV RNA result obtained within 60 days prior to Step 1 entry.
• •Negative hepatitis B surface antigen (HBsAg) result obtained within 60 days prior to Step 1 entry.
• •Ability and willingness to restart ART following ATI according to study guidelines.
• •Completion of pre-entry leukapheresis or Large Volume Blood Draw (LVBD).