Analytical Treatment Interruption (ATI) to Assess the Immune System's Ability to Control HIV in Participants Who Became HIV-infected During the HVTN 703/HPTN 081 AMP Study

Exclusion Criteria

• •Any plasma HIV-1 RNA ≥ LLOQ of VQA-certified or DAIDS-approved assay (LLOQ: 75, 50, 40, or 20 copies/mL) within 12 months prior to enrollment. NOTE: Two "blips" (ie, plasma HIV-1 RNA \> LLOQ) \< 400 copies/mL are allowed if preceded and followed by values \< LLOQ and if the blips occur more than 6 months prior to enrollment. Note: Sites must have results from locally available assays that are approved as standard-of-care by their regional governing bodies.
• •History of AIDS-defining illnesses or US Centers for Disease Control (CDC) Category C events per the current list on the CDC website.
• •Autoimmune disease, including Type I diabetes mellitus (Not excluded from participation: Volunteer with mild, stable and uncomplicated autoimmune disease that does not require consistent immunosuppressive medication and that, in the judgment of the site investigator, is likely not subject to exacerbation and likely not to complicate AE assessments).
• •Immunosuppressive medications received within 6 months before enrollment (Not exclusionary: \[1\] corticosteroid nasal spray; \[2\] inhaled corticosteroids; \[3\] topical corticosteroids for mild, uncomplicated dermatologic condition; or \[4\] a single course of oral/parenteral prednisone or equivalent at doses \< 60 mg/day and length of therapy \< 11 days with completion at least 30 days prior to enrollment).
• •Blood products received within 120 days before planned ART interruption.
• •Investigational research agents, other than experimental vaccine(s), received within 30 days before planned ART interruption.
• •HIV or non-HIV experimental vaccine(s) received within the last 1 year. Exceptions may be made by the HVTN 805/HPTN 093 PSRT for vaccines that have subsequently undergone licensure by the FDA or by the national regulatory authority where the volunteer is enrolling. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 805/HPTN 093 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 1 year ago, eligibility for enrollment will be determined by the HVTN 805/HPTN 093 PSRT on a case-by-case basis.
• •Licensed live attenuated vaccines received within 30 days before planned ART interruption (eg, measles, mumps, and rubella \[MMR\]; oral polio vaccine \[OPV\]; varicella; yellow fever; live attenuated influenza vaccine).
• •Licensed vaccines that are not live attenuated vaccines received within 14 days before planned ART interruption (eg, tetanus, pneumococcal, hepatitis A or B, influenza).
• •Receipt of any emergency-use authorized, WHO emergency use listed, licensed or registered SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) vaccine within 4 weeks before planned ART interruption.
• •Note: SARS-CoV-2 vaccination is not required for HVTN 805/HPTN 093 eligibility
• •Significant or unstable cardiac or cerebrovascular disease (eg, angina, congestive heart failure \[CHF\], recent cerebrovascular accident \[CVA\], or myocardial infarction \[MI\]).
• •Positive Hepatitis B surface antigen (HBsAg) or positive HCV RNA (Not exclusionary: positive HCV Ab with negative HCV RNA).
• •Pregnant or breastfeeding
• •Volunteers who have:
• •* a SARS-CoV-2 positive test (direct viral detection, eg, viral nucleic acid or antigen detection) ≤ 14 days of enrollment, if asymptomatic OR
• •* unresolved COVID-19 (ie, SARS-CoV-2 positive test AND symptoms) ≤ 14 days of enrollment (not excluded: individuals with symptoms consistent with residual sequelae of resolved COVID-19, in the clinical judgement of the investigator)
• •Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to:
• •* A process that would affect the immune response;
• •* A process that would require medication that affects the immune response;
• •* Any contraindication to repeated blood draws, including inability to establish venous access;
• •* A condition that requires active medical intervention or monitoring to avert grave danger to the volunteer's health or well-being during the study period; or
• •Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety, or a volunteer's ability to give informed consent.
• •Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, could be exacerbated by events associated with protocol participation, which include: ATI, low-level viremia, subsequent viral rebound, and ART re-initiation.
• •HIV dementia or other neurologic disease that, in the judgment of the investigator, would be a contraindication to study participation.
• •Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.
• •Malignancy (Not excluded from participation: Volunteer who has had malignancy excised surgically and who, in the investigator's judgment, has a reasonable assurance of sustained cure, or who is unlikely to experience recurrence of malignancy during the period of the study).
• •Current untreated or incompletely treated active tuberculosis disease or current latent tuberculosis infection (Not excluded from participation: Volunteer who has latent tuberculosis infection and is undergoing treatment, with at least one month of treatment completed)
• •Untreated or incompletely treated syphilis, gonorrhea, or chlamydia infection