A Phase 1/2a Study of PGT121, VRC07-523LS and PGDM1400 Monoclonal Antibodies in HIV-uninfected and HIV-infected Adults

Inclusion criteria

1. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study. 2. In the opinion of the Principal Investigator or designee and based on Assessment of Informed Consent Understanding results, has understood the information provided and potential impact and/or risks linked to IV infusion and participation in the trial; written informed consent will be obtained from the volunteer before any study-related procedures are performed. 3. All volunteers born female engaging in sexual activity that could lead to pregnancy must commit to use an effective method of contraception from the day of the first IV infusion of investigational product until 6 months following the final investigational product administration 4. All sexually active volunteers born male, regardless of reproductive potential, must be willing to consistently use an effective method of contraception from the day of investigational product administration until at least 6 months following the final investigational product administration to avoid exposure of partners to investigational product in ejaculate, and to prevent conception with female partners. 5. All volunteers born female must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Procedures and must test negative prior to investigational product administration. 6. All volunteers born female must agree not to donate eggs (ova, oocytes) for the purpose of assisted reproduction until 6 months after the final investigational product administration. Volunteers born male must agree not to donate sperm until 6 months after final investigational product administration. 7. Willing to forgo donations of blood and/or any other tissues, including bone marrow, during the study and, for those HIV-uninfected volunteers who test HIV-positive due to investigational product administration, until the anti-HIV antibody titers become undetectable. Specific inclusion criteria for HIV-uninfected volunteers (Group 1): 1. Healthy male or female, including transgender, volunteers, as assessed by a medical history, physical exam, and laboratory test 2. At least 18 years of age on the day of screening and has not reached his or her 51st birthday on the day of signing the Informed Consent Document 3. Willing to undergo HIV testing, risk reduction counseling and receive HIV test results 4. Low risk for HIV infection for 12 months prior to study participation and willing to maintain low-risk behavior for the duration of the trial Specific inclusion criteria for HIV-infected volunteers (Group 2): 1. At least 18 years of age on the day of screening and has not reached his or her 66th birthday on the day of signing the Informed Consent Document 2. Confirmed HIV-1 infection (HIV Ab+ or HIV RNA+) by documentation in the medical records or in-clinic HIV testing 3. CD4 ≥ 400 cells/µl 4. On antiretroviral therapy for a minimum of 24 months, with plasma HIV-1 RNA levels of \< 50 copies/ml for at least 12 months as documented in the medical records, and with a viral load \< 50 copies / ml at time of screening (within 56 days prior to IP administration). ART must not have been initiated during the acute phase of the infection as suggested by the available medical history and laboratory data from the time of the diagnosis. Note: ART is defined as a regimen including \> 2 compounds, e.g., 2x nucleoside reverse transcriptase inhibitors plus either non-nucleoside reverse transcriptase inhibitor or protease inhibitor or integrase inhibitor. 5. If on an NNRTI-based regimen, willing to switch to an integrase inhibitor containing regimen for 4 weeks prior to discontinuing ART 6. No history of AIDS-defining illness within the past 5 years 7. No history of CD4 nadir \<200 cells/ul 8. Under care of an HIV healthcare provider 5.6