NCT05224492

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4 hiv-infections

Timeline
Completed

Started Feb 2022

Shorter than P25 for phase_4 hiv-infections

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

February 21, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2022

Completed
Last Updated

February 7, 2022

Status Verified

February 1, 2022

Enrollment Period

5 months

First QC Date

February 1, 2022

Last Update Submit

February 3, 2022

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (2)

  • Lipids

    Triglycerides, Cholesterol

    4 months

  • Inflammatory Markers

    CRP

    4 months

Study Arms (2)

Sulforaphane Group

EXPERIMENTAL
Drug: Sulforaphane

Placebo Group

PLACEBO COMPARATOR
Other: Placebo

Interventions

SulforaphaneDRUG

40 mg of Sulforaphane powder once daily.

Sulforaphane Group
PlaceboOTHER

Placebo

Placebo Group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • years of age.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HIV Infections

Interventions

sulforaphane

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Jose A. Giron, MD

    Sunshine Specialty Health Care

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Johannah G Katz

CONTACT

4074894750Johannahfgiron@gmail.com

Jose A. Giron, MD

CONTACT

4078885980Joseoidc@aol.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2022

First Posted

February 4, 2022

Study Start

February 21, 2022

Primary Completion

July 21, 2022

Study Completion

September 21, 2022

Last Updated

February 7, 2022

Record last verified: 2022-02