Sulforaphane Use to Effect Inflammatory and Metabolic Changes in Virally Suppressed HIV Patients

Sunshine Specialty Health Care

Status and phase: Unknown; Phase 4

Conditions: HIV Infections

Treatments: Drug: Sulforaphane; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05224492

SSHC1001

Details and patient eligibility

About

Assess the effects of Sulforaphane supplementation in HIV patients that have achieved viral suppression.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HIV patients on active treatment who have a suppressed viral load and have been virally suppressed for 6 months or more.
• BMI increase of 10% or more since initiation of HIV treatment over a year period.
• BMI equal to or greater than 30.
• 18-85 years of age.

Exclusion criteria

• Cancer
• Pregnancy or breastfeeding
• Intolerance to cruciferous vegetables
• Intolerance to sulforaphane
• Gluten Intolerance
• Creatinine > 1.3 mg/dL
• GFR < 60
• AST or ALT > 1.5 times upper limit of normal.
• White cell count < 2000 cells per ml.
• Hemoglobin < 10.5 g/dL.
• Platelet count < 140,000 per ml.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

20 participants in 2 patient groups, including a placebo group

Sulforaphane Group

Experimental group

Treatment:

Drug: Sulforaphane

Placebo Group

Placebo Comparator group

Treatment:

Other: Placebo