Safety and Therapeutic Efficacy of the VRC01 Antibody in Patients Who Initiated Antiretroviral Therapy During Early Acute HIV Infection
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Intervention: VRC01; Placebo for VRC01
Intervention description: 40 mg/kg; administered IV; Sodium Chloride for Injection 0.9%, USP; administered IV
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 20 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Human Monoclonal Antibody

Summary:

      The study will evaluate the safety and therapeutic efficacy of the human monoclonal antibody
      (mAb) VRC-HIVMAB060-00-AB (VRC01), when administered during analytic treatment interruption
      (ATI), in adults who began antiretroviral therapy (ART) during early acute HIV infection.
    

Eligibility criteria:

        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.