InflammationPhase 1/2NCT04939311
Immunomodulation Using VB-201 to Reduce Arterial Inflammation in Treated HIV - VITAL HIV Trial
A Phase 1/2 study testing VB-201 in people with Inflammation and HIV Infection, run by Priscilla Hsue, MD at 1 site in United States.
Trial summary
This study is a double blinded, placebo-controlled, randomized, parallel group study, designed to compare the efficacy and safety of VB-201 80mg taken orally once daily to placebo for anti-inflammation in HIV-infected subjects. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Inflammation, HIV Infection, Cardiovascular Disease
- What is being tested?
- VB-201
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 1 Jul 2027
- Phase
- Phase 1/2
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented HIV infection
- On continuous antiretroviral therapy and virologically suppressed HIV infection for ≥12 weeks prior to study entry
- CD4 T-cell count > 350 cells/mm3
- Male or female between the ages ≥ 40 years of age to <≤75
- Documented cardiovascular disease (1. Prior myocardial infarction, 2. History of percutaneous coronary intervention, 3. History of coronary artery bypass graft OR 4. Angiographic evidence of >50% stenosis in at least one coronary artery] OR 1 CVD risk factor (T2DM, current smoking, hypertension, dyslipidemia, hsCRP≥2mg/L, family history)
- TBR of >1.6 of the MDS of the carotid/aorta at baseline. This baseline arterial TBR cutoff excludes the rare individual that lacks appreciable arterial inflammation. It is notable that while 5-10% of uninfected individuals will have lower TBRs, it is rare that an HIV infected individual will fall below this range.
- Female subjects must either be of non-childbearing potential as defined by menopause with amenorrhea for >2 years, bilateral oophorectomy, or agree to use adequate contraception throughout the study and for at least one month following termination and have a negative pregnancy test at screening prior to the first dose of drug.
- Males must use at least one method of contraception throughout the study.
Who cannot join
- Pregnant/nursing women
- Uncontrolled hypertension or diabetes requiring insulin
- AST/ALT or alkaline phosphatase >2x ULN
- Cancer within the last 5 years with exception of squamous cell carcinoma and basal cell carcinoma
- Nephrotic syndrome or eGFR <60 mL/min/1.73m2
- Cytopenias which include 1) WBC <3.5 x103/uL 2) Platelet <120 x103/uL 3) ANC <1.5 x103/uL, and absolute lymphocytes <0.8 x 103/uL
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- Anemia as fined by <10 g/dL
- Evidence of tuberculosis infection at screening within 30 days prior to screening.
- Family history of long QT syndrome, using medication that prolongs QT internal, OR evidence of prolonged QT of >470 msec as evidenced by ECG
- Acute systemic infection within 30 days
- On additional immunosuppressant or immunomodulatory therapies
Trial locations and contacts
1 site in 1 country.
United States1 site
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
About this study
This study is a double blinded, placebo-controlled, randomized, parallel group study, designed to compare the efficacy and safety of VB-201 80mg taken orally once daily to placebo for anti-inflammation in HIV-infected subjects.
- Conditions
- Inflammation, HIV Infection, Cardiovascular Disease
- Being tested
- VB-201, Placebo
- Medical subject headings
- Inflammation, HIV Infections, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VB-201Drug
One dose of VB-201 80 mg (1 tablet) will be administered orally once daily for 52 weeks.
PlaceboDrug
One dose of placebo 80 mg (1 tablet) will be administered orally once daily for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| VB-201 | Experimental | One dose of VB-201 80 mg (1 tablet) will be administered orally once daily for 52 weeks. Receives: Drug: VB-201 |
| Placebo | Placebo comparator | One dose of placebo 80 mg (1 tablet) will be administered orally once daily for 52 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Target-to-background ratio (TBR)
Change in Target-to-background ratio (TBR) from baseline to follow-up study at 52 weeks as assessed by Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG PET/CT)
Measured: 1 year (Baseline and Week 52)
Secondary outcomes (8)
Change in high sensitivity C-reactive protein (hs-CRP) in mg/L
Change in hs-CRP from baseline to week 24 and baseline to week 52 as measured by blood collection
Measured: 1 year (Change from baseline to week 24 and baseline to week 52)
Change in Interleukin-6 (IL-6) in pg/mL
Change in IL-6 from baseline to week 24 and baseline to week 52 as measured by blood collection
Measured: 1 year (Change from baseline to week 24 and baseline to week 52)
Change in soluble cluster of differentiation (sCD163) ng/mL
Change in sCD163 from baseline to week 24 and baseline to week 52 as measured by blood collection
Measured: 1 year (Change from baseline to week 24 and baseline to week 52)
Change in Lipoprotein (a) [Lp(a)] in mg/dL
Change in Lp(a) from baseline to week 24 and baseline to week 52 as measured by blood collection
Measured: 1 year (Change from baseline to week 24 and baseline to week 52)
Change in Lipoprotein-associated Phospholipase A2 (Lp-PLA2) in ng/mL
Change in Lp-PLA2 from baseline to week 24 and baseline to week 52 as measured by blood collection
Measured: 1 year (Change from baseline to week 24 and baseline to week 52)
Change in D-Dimer (ng/mL)
Change in D-Dimer from baseline to week 24 and baseline to week 52 as measured by blood collection
Measured: 1 year (Change from baseline to week 24 and baseline to week 52)
Change in Markers of Immune Activation
Change in Co-expression of HLA-DR/CD38 on T-cells from baseline to week 24 and baseline to week 52 as measured by blood collection
Measured: 1 year (Change from baseline to week 24 and baseline to week 52)
Change in Monocyte Activation
Change in Co-expression of CD14/CD16 on Monocytes from baseline to week 24 and baseline to week 52
Measured: 1 year (Change from baseline to week 24 and baseline to week 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start1 Jul 2022 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Why it stopped: Funding for this trial has not been established.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Priscilla Hsue, MD
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, University of Utah
- Responsible party
- Sponsor-investigator, Priscilla Hsue, MD, University of California, San Francisco
- Investigators
- Priscilla Hsue, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939311
- Sponsor's protocol ID
- VITAL HIV
- Status last verified
- Sep 2022
- First submitted
- 3 Jun 2021
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomodulation Using VB-201 to Reduce Arterial Inflammation in Treated HIV - VITAL HIV Trial
- ClinicalTrials.gov ID
- NCT04939311
- Acronym / sponsor ID
- VITAL HIV
- Conditions
- Inflammation, HIV Infection, Cardiovascular Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding for this trial has not been established.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Priscilla Hsue, MDUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, University of Utah
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 25 Jun 2021 (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.
This study is a double blinded, placebo-controlled, randomized, parallel group study, designed to compare the efficacy and safety of VB-201 80mg taken orally once daily to placebo for anti-inflammation in HIV-infected subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VB-201 | Experimental | Drug: VB-201One dose of VB-201 80 mg (1 tablet) will be administered orally once daily for 52 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboOne dose of placebo 80 mg (1 tablet) will be administered orally once daily for 52 weeks. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Documented HIV infection
- On continuous antiretroviral therapy and virologically suppressed HIV infection for ≥12 weeks prior to study entry
- CD4 T-cell count > 350 cells/mm3
- Male or female between the ages ≥ 40 years of age to <≤75
- Documented cardiovascular disease (1. Prior myocardial infarction, 2. History of percutaneous coronary intervention, 3. History of coronary artery bypass graft OR 4. Angiographic evidence of >50% stenosis in at least one coronary artery] OR 1 CVD risk factor (T2DM, current smoking, hypertension, dyslipidemia, hsCRP≥2mg/L, family history)
Key exclusion criteria (11 listed)
- Pregnant/nursing women
- Uncontrolled hypertension or diabetes requiring insulin
- AST/ALT or alkaline phosphatase >2x ULN
- Cancer within the last 5 years with exception of squamous cell carcinoma and basal cell carcinoma
- Nephrotic syndrome or eGFR <60 mL/min/1.73m2
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 |
|---|---|---|
| VB-201One dose of VB-201 80 mg (1 tablet) will be administered orally once daily for 52 weeks. | Drug | VB-201 |
| PlaceboOne dose of placebo 80 mg (1 tablet) will be administered orally once daily for 52 weeks. | Drug | Placebo |
Primary outcome
Change in Target-to-background ratio (TBR)
Time frame: 1 year (Baseline and Week 52)
Change in Target-to-background ratio (TBR) from baseline to follow-up study at 52 weeks as assessed by Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG PET/CT)
8 secondary outcomes
Change in high sensitivity C-reactive protein (hs-CRP) in mg/L
Time frame: 1 year (Change from baseline to week 24 and baseline to week 52)
Change in Interleukin-6 (IL-6) in pg/mL
Time frame: 1 year (Change from baseline to week 24 and baseline to week 52)
Change in soluble cluster of differentiation (sCD163) ng/mL
Time frame: 1 year (Change from baseline to week 24 and baseline to week 52)
Change in Lipoprotein (a) [Lp(a)] in mg/dL
Time frame: 1 year (Change from baseline to week 24 and baseline to week 52)
Change in Lipoprotein-associated Phospholipase A2 (Lp-PLA2) in ng/mL
Time frame: 1 year (Change from baseline to week 24 and baseline to week 52)
Change in D-Dimer (ng/mL)
Time frame: 1 year (Change from baseline to week 24 and baseline to week 52)
Change in Markers of Immune Activation
Time frame: 1 year (Change from baseline to week 24 and baseline to week 52)
Change in Monocyte Activation
Time frame: 1 year (Change from baseline to week 24 and baseline to week 52)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Priscilla Hsue, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VB-201 in people with Inflammation and HIV Infection, run by Priscilla Hsue, MD at 1 site in United States.
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 8 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: withdrawn, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Target-to-background ratio (TBR) (time frame: 1 year (Baseline and Week 52)). 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 15 Sep 2022.