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Phase 1 N=15 Prevention

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

HIV-1 Infection

Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Percent of Participants With a Grade 3 or Higher Treatment-Related Adverse Event (AE) — 0 percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
VRC07-523LS (Biological); Vorinostat (VOR) (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
University of North Carolina, Chapel Hill
Primary completion
Jan 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Percent of Participants With a Grade 3 or Higher Treatment-Related Adverse Event (AE)

Summary

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.

Eligibility Criteria

Inclusion Criteria

  • ≥ 18 years and 115 kg
  • Untreated syphilis infection (defined as a positive rapid plasma reagin (RPR) without clear documentation of treatment).

Note: In cases of untreated syphilis, participant may rescreen following documentation of adequate treatment of syphilis

  • Current treatment for HCV with antiviral therapy or participants who have received HCV treatment within 6 months prior to screening.
  • Use of any of the following within 90 days prior to entry: immunosuppressive, immunomodulatory, cytokine, or growth stimulating factors such as systemic corticosteroids, cyclosporine, methotrexate, azathioprine, anti-CD25 antibody, interferon (IFN), interleukin-2 (IL-2).

Not Exclusionary: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical steroids for mild, uncomplicated dermatitis; or [4] a single course of oral /parental prednisone or equivalent at doses 150 mm Hg systolic and >100 mm Hg diastolic.

Note: Elevated BP occurring during research leukapheresis procedures completed within the past 12 months are excluded from this requirement. Acceptable isolated elevations must be noted as acceptable and signed by study PI or designee.

  • Unstable asthma (e.g., sudden acute attacks occurring without an obvious trigger) or either of the following in the past 12 months:
  • >1 exacerbation of symptoms treated with oral/parental corticosteroids;
  • Emergency care, urgent care, hospitalization, or intubation for asthma.
  • Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions)
  • Seizure disorder: History of seizure(s) within past three years or use of medications used to prevent or treat seizure(s) at any time within the past 3 years.
  • History of asplenia - absence of normal spleen function as indicated by:
  • Splenectomy
  • Sickle cell disease
  • History of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
  • Prisoner recruitment and participation is not permitted.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03803605). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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