HIV InfectionsPhase 4NCT05224492
Sulforaphane Use to Effect Inflammatory and Metabolic Changes in Virally Suppressed HIV Patients
A Phase 4 study testing Sulforaphane in people with HIV Infections, run by Sunshine Specialty Health Care.
Trial summary
Assess the effects of Sulforaphane supplementation in HIV patients that have achieved viral suppression. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Sulforaphane
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 21 Feb 2022to 21 Sep 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Cancer
- Pregnancy or breastfeeding
- Intolerance to cruciferous vegetables
- Intolerance to sulforaphane
- Gluten Intolerance
- Creatinine > 1.3 mg/dL
Show all 11Show fewer
- 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 locations and contacts
No sites are listed yet.
About this study
Assess the effects of Sulforaphane supplementation in HIV patients that have achieved viral suppression.
- Conditions
- HIV Infections
- Being tested
- Sulforaphane, Placebo
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulforaphaneDrug
40 mg of Sulforaphane powder once daily.
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Sulforaphane Group | Experimental | Not described Receives: Drug: Sulforaphane |
| Placebo Group | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipids
Triglycerides, Cholesterol
Measured: 4 months
Inflammatory Markers
CRP
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start21 Feb 2022 (estimated)
- Primary completion21 Jul 2022 (estimated)
- Study completion21 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunshine Specialty Health Care
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose A. Giron, MD, Principal investigator, Sunshine Specialty Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224492
- Sponsor's protocol ID
- SSHC1001
- Status last verified
- Feb 2022
- First submitted
- 1 Feb 2022
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sulforaphane Use to Effect Inflammatory and Metabolic Changes in Virally Suppressed HIV Patients
- ClinicalTrials.gov ID
- NCT05224492
- Acronym / sponsor ID
- SSHC1001
- Conditions
- HIV Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sunshine Specialty Health CareUniversity, hospital or other
- Study start
- 21 Feb 2022 (estimated)
- Primary completion
- 21 Jul 2022 (estimated)
- Study completion
- 21 Sep 2022 (estimated)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess the effects of Sulforaphane supplementation in HIV patients that have achieved viral suppression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sulforaphane Group | Experimental | Drug: Sulforaphane |
| Placebo Group | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- Cancer
- Pregnancy or breastfeeding
- Intolerance to cruciferous vegetables
- Intolerance to sulforaphane
- Gluten Intolerance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sulforaphane40 mg of Sulforaphane powder once daily. | Drug | Sulforaphane Group |
| PlaceboPlacebo | Other | Placebo Group |
Primary outcome
Lipids
Time frame: 4 months
Triglycerides, Cholesterol
Inflammatory Markers
Time frame: 4 months
CRP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose A. Giron, MD principal investigator
Sunshine Specialty Health Care
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sulforaphane in people with HIV Infections, run by Sunshine Specialty Health Care.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johannah G Katz (4074894750, Johannahfgiron@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipids (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.