Study to Assess Safety and Activity of Combination Therapy of VRC07-523LS and Vorinostat on HIV-infected Persons

Conditions

• HIV-1 Infection

Eligibility Criteria

Sex

ALL

Age

18 Years - 64 Years

Healthy Volunteers

Not accepted

Interventions

• VRC07-523LS — BIOLOGICAL
  VRC07-523LS 40 mg/kg administered intravenously per series (total of 2 infusions administered)
• Vorinostat (VOR) — DRUG
  Vorinostat 400 mg administered orally every 72 hours for 10 doses per series (A total of 20 400-mg doses administered)

Study Details

Adult participants (18-64 years old) with HIV-1 Infection on ART with a CD4 T cell count ≥ 350 cells/mm3 and viral suppression for ≥ 24 months will be enrolled on this study. Participants will receive two series of combination therapy consisting of one (1) intravenous (IV) dose of VRC-HIVMAB075-00-AB (VRC07-523LS) followed by 10 oral (PO) doses of Vorinostat (VOR) taken every 72 hours. Each series will last approximately 1 month and the two series will be separated by at least one month. Combination ART is maintained throughout the study. Participants will be on this study for approximately 28 weeks (or about 7 months). The purpose of this study is to: * Evaluate the safety of two series of a VRC07-523LS infusion followed by multiple oral doses of VOR * Determine if combining VRC07-523LS and VOR can have an impact on non-active HIV virus.

Key Dates

Start date

Feb 12, 2019

Status verified

Jul 2021

Primary completion

Jan 28, 2021

Completion

Jan 28, 2021

Study Design

Enrollment

15 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Arms

• Experimental: VRC07-523LS + Vorinostat (VOR)
  Participants will receive two series of combination therapy consisting of one (1) intravenous (IV) dose of VRC-HIVMAB075-00-AB (VRC07-523LS) followed by 10 oral (PO) doses of Vorinostat (VOR) taken every 72 hours.

Primary Outcome Measure

Percent of Participants With a Grade 3 or Higher Treatment-Related Adverse Event (AE) [ Time Frame: First day of study treatment through end of study, a total of approximately 36 weeks ]

Locations (1)

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