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

Primary Purpose

HIV Infections

Status

Not yet recruiting

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Sulforaphane

Placebo

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sulforaphane Group

Placebo Group

Arm Description

Outcomes

Primary Outcome Measures

Lipids

Triglycerides, Cholesterol

Inflammatory Markers

CRP

Secondary Outcome Measures

Full Information

NCT ID

NCT05224492

First Posted

February 1, 2022

Last Updated

February 3, 2022

Sponsor

Sunshine Specialty Health Care

1. Study Identification

Unique Protocol Identification Number

NCT05224492

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

February 21, 2022 (Anticipated)

Primary Completion Date

July 21, 2022 (Anticipated)

Study Completion Date

September 21, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sunshine Specialty Health Care

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sulforaphane Group

Arm Type

Experimental

Arm Title

Placebo Group

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Sulforaphane

Intervention Description

40 mg of Sulforaphane powder once daily.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Lipids

Description

Triglycerides, Cholesterol

Time Frame

4 months

Title

Inflammatory Markers

Description

CRP

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Johannah G Katz

Phone

4074894750

Johannahfgiron@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jose A. Giron, MD

Phone

4078885980

Joseoidc@aol.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jose A. Giron, MD

Organizational Affiliation

Sunshine Specialty Health Care

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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