Safety and Therapeutic Efficacy of the VRC01 Antibody in Patients Who Initiated Antiretroviral Therapy During Early Acute HIV Infection

Inclusion Criteria:

• Able and willing to provide written informed consent or, in the case of illiteracy, witnessed verbal informed consent with documentation of a thumbprint in lieu of a signature.
• Passes Test of Understanding.
• Man or woman aged 20-50 years.
• Initiated on ART during acute HIV infection (Fiebig Stage I to III at RV 254 enrollment).
• Prescribed ART for at least 24 months prior to enrollment.
• HIV-1 RNA less than 50 copies/mL on at least three consecutive measurements within the past 12 months.
• Integrated HIV DNA in peripheral blood mononuclear cells (PBMCs) below the level of detection (1 copy/10^5 PBMCs) within 6 months prior to enrollment.
• Last documented peripheral blood CD4 greater than 400 cells/mm^3 within 3 months prior to enrollment.
• No HIV-related or AIDS-defining illness within 6 months prior to enrollment.
• In general good health.
• Able to participate in study visits.

Female-Specific Criteria:

• Agrees not to become pregnant from the time of study enrollment until the last study visit. If a woman is sexually active and has no history of hysterectomy or tubal ligation or menopause, she must agree to use a prescription birth control method or a barrier birth control method.
• Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test (urine or serum) on day of enrollment for any women unless she is post-menopause for 24 consecutive months or has undergone a surgical procedure that precludes pregnancy.

Exclusion Criteria:

• Previous receipt of humanized or human monoclonal antibody whether licensed or investigational.
• Ongoing AIDS-related opportunistic infection (including oral thrush).
• Active injection drug use within previous 12 months.
• History of a severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis in the 2 years prior to enrollment.
• History of chronic urticaria requiring daily treatment.
• Physical finding on examination considered indicative of significant disease such as murmur (other than functional), hepatosplenomegaly, or focal neurologic deficit.
• Hypertension that is not well controlled by medication.
• Hepatitis B surface antigen positive at any time in the past.
• Hepatitis C antibody positive at any time in the past.
• Untreated syphilis.
• Estimated glomerular filtration rate (GFR) less than 50 ml/min within the past 90 days.
• Pregnant or breastfeeding.
• Receipt of licensed vaccine or other investigational study agent within 28 days prior to enrollment or past participation in an investigational HIV vaccine study with receipt of active product.
• Current or planned participation in another interventional clinical trial during the study period.
• Chronic or recurrent use of medications that modify host immune response, e.g., oral or parenteral steroids, cancer chemotherapy.
• Any other chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the volunteer. Including, but not limited to: diabetes mellitus type I, chronic hepatitis, renal failure; OR clinically significant forms of: drug or alcohol abuse, mental illness, severe asthma, autoimmune disease, psychiatric disorders, heart disease, or cancer.
• Study site employee.