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

• Sponsor: Sunshine Specialty Health Care (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05224492
• Collaborator: (none)
• Enrollment: 20
• Arms: 2
• Anticipated Duration (Months): 7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Sulforaphane; Other: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Sulforaphane Use to Effect Inflammatory and Metabolic Changes in Virally Suppressed HIV Patients
• Anticipated Study Start Date: Feb 21, 2022
• Anticipated Primary Completion Date: Jul 21, 2022
• Anticipated Study Completion Date: Sep 21, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sulforaphane Group	Drug: Sulforaphane; 40 mg of Sulforaphane powder once daily.
Placebo Comparator: Placebo Group	Other: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Lipids [4 months]

   Triglycerides, Cholesterol

2. Inflammatory Markers [4 months]

   CRP

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Sunshine Specialty Health Care

Investigators

• Principal Investigator: Jose A. Giron, MD, Sunshine Specialty Health Care

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sunshine Specialty Health Care
• ClinicalTrials.gov Identifier: NCT05224492
• Other Study ID Numbers: SSHC1001
• First Posted: Feb 4, 2022
• Last Update Posted: Feb 7, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: HIV Infections; Sulforaphane

Study Results

No Results Posted as of Feb 7, 2022