10E8.4/iMab Bispecific Antibody and VRC07-523LS Monoclonal Antibody in HIV-infected Adults

Inclusion Criteria:

1. Able to read and write in Kiswahili and/or English

2. Able and willing to provide written informed consent

3. Passes Test of Understanding (TOU)

4. Aged 18-50 years, inclusive

5. Antiretroviral Therapy (ART)-naïve or no ART for > 24 weeks at the time of screening

6. HIV RNA 1,000-100,000 copies/mL

7. CD4 ≥ 500 cells/mm3

8. Laboratory criteria at screening within protocol-specified limits for blood,chemistry and urinalysis

9. Willing and able to participate in study visits and procedures for up to 50 weeks

10. Willing and able to begin ART as directed during the study

11. Willing and able to use barrier protection during sex with partners without HIV orpartners with unknown HIV status throughout Step 1 and until viral suppression <200copies/mL is confirmed in Step 2

12. Willing and able to adhere to the following contraception requirements:

13. Participants who are able to become pregnant must agree to use at least onemethod of highly effective contraception if participating in sexual activitythat could lead to pregnancy. This must begin at least 14 days prior to studyenrollment.

14. Participants who engage in sexual activity that could lead to their partnerbecoming pregnant and who are of reproductive potential must agree to use abarrier method of contraception to avoid pregnancy in a sexual partner ofreproductive potential. The barrier method must be used for the duration of thestudy.

Exclusion Criteria:

1. Weight >100 kg

2. Previous receipt of humanized or human monoclonal antibody whether licensed orinvestigational (other than for the prevention and/or treatment ofSARS-CoV2/COVID-19)

3. History of viral failure on two or more ART regimens

4. Planned or anticipated need for enfuvirtide, maraviroc, fostemsavir, or ibalizumabfor antiretroviral therapy.

5. AIDS-defining illness, as enumerated by the WHO Stage 3 or 4, within the six monthsprior to enrollment

6. Ongoing oral thrush

7. Active injection or other recreational drug use within the previous 12 months that,in the opinion of the investigator, would impede the participant's ability to safelyand consistently adhere to the study protocol

8. History of a severe allergic reaction with generalized urticaria, angioedema oranaphylaxis in the 2 years prior to enrollment.

9. History of chronic urticaria requiring daily treatment

10. Known active hepatitis B virus infection or positive hepatitis B surface antigen atany time in the past

11. Known active hepatitis C virus infection or positive hepatitis C antibody at anytime in the past

12. Untreated syphilis

13. Estimated GFR < 50 mL/min within the past 90 days

14. Pregnant or breast-feeding

15. Receipt of licensed vaccine or other investigational study agent within 28 daysprior to enrollment or any past participation in an investigational HIV vaccinestudy with receipt of active product

16. Current or planned participation in another interventional clinical trial during thestudy period, including clinical trials of investigational new drugs orinvestigating a new application for an approved medication

17. Chronic or recurrent use of medications that modify host immune response, such asoral steroids, parenteral steroids, or cancer chemotherapy (note: locally-actingmedications-such as inhaled, topical, or intra-articular steroids-are allowed)

18. Any other chronic or clinically significant medical condition that in the opinion ofthe investigator would jeopardize the safety or rights of the participant including,but not limited to: diabetes mellitus type I, chronic hepatitis, renal failure; ORclinically significant forms of: drug or alcohol abuse, mental illness, severeasthma, autoimmune disease, decompensated psychiatric disorders, hypertension, heartdisease, or cancer

19. Any medications that, in the opinion of the investigator, would precludeintramuscular injections

20. Study site employee