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

Phase 4

• Conditions: HIV Infections
• Interventions: Other: Placebo; Drug: Sulforaphane

• Registration Number: NCT05224492
• Lead Sponsor: Sunshine Specialty Health Care

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-01
• Study First Submitted QC: 2022-02-03
• Last Update Submitted: 2022-02-03
• Study First Posted: 2022-02-04
• Last Update Posted: 2022-02-07
• Study Start: 2022-02-21
• Primary Completion: 2022-07-21
• Study Completion: 2022-09-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	-
Sulforaphane Group	Sulforaphane	-

Primary Outcome Measures

Name	Time	Method
Inflammatory Markers	4 months	CRP
Lipids	4 months	Triglycerides, Cholesterol