Study to Assess Safety and Activity of Combination Therapy of VRC07-523LS and Vorinostat on HIV-infected Persons
HIV-1 Infection
Bottom Line
View on ClinicalTrials.gov: NCT03803605 ↗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
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants With a Grade 3 or Higher Treatment-Related Adverse Event (AE) |
— | — |
Summary
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.
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.