InflammationPhase 2TACTICAL-HIVNCT02339415
Targeted Anticoagulation Therapy to Reduce Inflammation and Cellular Activation in Long-term HIV Disease
A Phase 2 study testing Edoxaban 30mg daily in people with Inflammation and Coagulation, run by Hennepin Healthcare Research Institute at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the effects of pharmacologic FXa inhibition (via edoxaban 30 mg daily) on inflammation, as reflected in plasma Interleukin-6 levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation, Coagulation, HIV Infection
- What is being tested?
- Edoxaban 30mg daily
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2015to Sep 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infection (verified by previous positive antibody or detectable HIV RNA level)
- Age ≥18 years
- Receiving continuous ART for ≥2 years (regimen changes >3 months prior to enrollment are acceptable)
- HIV RNA level ≤200 copies/mL for ≥1 year (1 measure ≥200 allowed if also <500 and preceded and followed by one or more values ≤200 copies/mL)
- D-dimer level ≥100 mg/L (or ng/mL) at screening (or within the prior month)
- Estimated creatinine clearance ≥50 mL/min
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- Body weight ≥60kg
- Do not anticipate starting (or stopping) statin or aspirin therapy during the study
- For women of child bearing potential, agrees to use a reliable form of birth control
Who cannot join
- Pregnancy or breast feeding
- A contra-indication to taking edoxaban
- A clinical indication for anticoagulation therapy (e.g., atrial fibrillation or Deep Vein Thrombosis/PE)
- Treatment with anti-platelet, anti-coagulation, or immune-modulatory drugs currently or within the past 6 months; prior self-limited treatment with aspirin (i.e., not daily use) is not itself an exclusion.
- Grade ≥1 hematology lab abnormality for INR (>1.1 x ULN), hemoglobin (<10.0 g/L), platelets (<100,000 cells/μL), and WBC (2,500 cells/mm3)
- Grade ≥2 lab abnormality for chemistries (BMP) or liver panel
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- Alcohol or illicit drug abuse/dependency within the prior year
- History of prior myocardial infarction or unstable atherosclerotic disease
- History of prior stroke or transient ischemic attack (TIA)
- History of active gastrointestinal ulcer or bleeding disorder within the prior year
- Intent to have surgery during the study period (12 months)
- Hepatitis C treatments (e.g., interferon, ribavirin, protease inhibitors) within the past 6 months
- Cirrhosis or hepatic impairment (e.g., Child-Pugh class B or C).
- Seizure disorder
- Previous/current CNS space occupying lesion (e.g., Toxoplasmosis, mTB) with persistent abnormalities on CNS imaging after completion of treatment.
- Surgical or invasive procedure anticipated during study period.
- Invasive cancer in the prior year or receiving cancer treatment (not including carcinoma-in-situ or basal cell cancer of the skin)
- Rheumatologic or inflammatory disease, systemic in nature (e.g., systemic lupus erythematosus, rheumatoid arthritis, vasculitis, sarcoidosis, Crohn's disease)
- Assessment by the clinical investigator that enrollment into the study could entail excess risk to the participant, beyond what is intended or expected.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Hennepin County Medical Center
Minneapolis, Minnesota, 55417
About this study
The purpose of this study is to evaluate the effects of pharmacologic FXa inhibition (via edoxaban 30 mg daily) on inflammation, as reflected in plasma Interleukin-6 levels.
Read the detailed description
We hypothesize that increased generation of activated factor X (FXa) contributes to a systemic elevation in pro-inflammatory cytokine levels (e.g. IL-6) among HIV positive patients. This occurs, in part, via FXa activation of protease activated receptor 2 (PAR-2) on monocytes and tissue macrophages, which perpetuates innate inflammation. We will test our hypothesis with an oral antagonist to FXa (edoxaban), and quantify the immunologic effects of PAR-2 inhibition on systemic inflammation and monocyte activation.
The potential benefits of pharmacologic inhibition of FXa will be studied among HIV positive participants receiving ART with suppressed HIV viral load and a D-dimer >100 ng/mL. The study design is a cross-over placebo controlled randomized trial of edoxaban 30mg daily versus matched placebo (n=40 total participants). After screening and baseline visits, participants will be randomized to the sequence of drug administration (i.e., edoxaban vs. placebo). After randomization, participants will start study medication #1 and follow-up for visits at months 1, 2, 3 and 4. They will then stop study medication for 3 months, return for visits at months 7 and 8 (analogous to screening and baseline, respectively), then start study medication #2 and follow-up for visits at months 9, 10, 11, and 12.
The treatment effect (i.e., changes from pre-treatment levels) over 4 months will be assessed in measures of inflammation, immune activation, and coagulation. For comparisons with placebo, each participant will then serve as his or her own control in this cross-over design.
- Conditions
- Inflammation, Coagulation, HIV Infection
- Being tested
- Edoxaban 30mg daily, Matching placebo
- Medical subject headings
- Inflammation, Thrombosis, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edoxaban 30mg dailyDrug
Matching placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Edoxaban 30mg daily Receives: Drug: Edoxaban 30mg daily |
| Placebo | Placebo comparator | Matching Placebo Receives: Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Interleukin 6 (IL-6) Plasma Levels From Baseline to 4 Months.
Difference between treatment and control ln-transformed IL-6 plasma levels in change from pre-treatment to on-treatment values
Measured: Through study completion, an average of 4 months on each treatment.
Secondary outcomes (1)
Change in D-Dimer Levels From Baseline to 4 Months
Difference between treatment and control ln-transformed D-Dimer levels in change from pre-treatment to on-treatment values
Measured: Through study completion, an average of 4 months on each treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2015 (estimated)
- Study startJul 2015
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Baker, Hennepin Healthcare Research Institute
- Investigators
- Jason Baker, M.D., Principal investigator, Hennepin Healthcare Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339415
- Sponsor's protocol ID
- PCC-008
- Acronym
- TACTICAL-HIV
- Status last verified
- Aug 2019
- First submitted
- 12 Jan 2015
- Last updated
- 6 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Anticoagulation Therapy to Reduce Inflammation and Cellular Activation in Long-term HIV Disease
- ClinicalTrials.gov ID
- NCT02339415
- Acronym / sponsor ID
- TACTICAL-HIV / PCC-008
- Conditions
- Inflammation, Coagulation, HIV Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 15 Jan 2015 (estimated)
- Results
- Posted 6 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effects of pharmacologic FXa inhibition (via edoxaban 30 mg daily) on inflammation, as reflected in plasma Interleukin-6 levels.
Detailed description
We hypothesize that increased generation of activated factor X (FXa) contributes to a systemic elevation in pro-inflammatory cytokine levels (e.g. IL-6) among HIV positive patients. This occurs, in part, via FXa activation of protease activated receptor 2 (PAR-2) on monocytes and tissue macrophages, which perpetuates innate inflammation. We will test our hypothesis with an oral antagonist to FXa (edoxaban), and quantify the immunologic effects of PAR-2 inhibition on systemic inflammation and monocyte activation.
The potential benefits of pharmacologic inhibition of FXa will be studied among HIV positive participants receiving ART with suppressed HIV viral load and a D-dimer >100 ng/mL. The study design is a cross-over placebo controlled randomized trial of edoxaban 30mg daily versus matched placebo (n=40 total participants). After screening and baseline visits, participants will be randomized to the sequence of drug administration (i.e., edoxaban vs. placebo). After randomization, participants will start study medication #1 and follow-up for visits at months 1, 2, 3 and 4. They will then stop study medication for 3 months, return for visits at months 7 and 8 (analogous to screening and baseline, respectively), then start study medication #2 and follow-up for visits at months 9, 10, 11, and 12.
The treatment effect (i.e., changes from pre-treatment levels) over 4 months will be assessed in measures of inflammation, immune activation, and coagulation. For comparisons with placebo, each participant will then serve as his or her own control in this cross-over design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Drug: Edoxaban 30mg dailyEdoxaban 30mg daily |
| Placebo | Placebo comparator | Drug: Matching placeboMatching Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- HIV infection (verified by previous positive antibody or detectable HIV RNA level)
- Age ≥18 years
- Receiving continuous ART for ≥2 years (regimen changes >3 months prior to enrollment are acceptable)
- HIV RNA level ≤200 copies/mL for ≥1 year (1 measure ≥200 allowed if also <500 and preceded and followed by one or more values ≤200 copies/mL)
- D-dimer level ≥100 mg/L (or ng/mL) at screening (or within the prior month)
Key exclusion criteria (19 listed)
- Pregnancy or breast feeding
- A contra-indication to taking edoxaban
- A clinical indication for anticoagulation therapy (e.g., atrial fibrillation or Deep Vein Thrombosis/PE)
- Treatment with anti-platelet, anti-coagulation, or immune-modulatory drugs currently or within the past 6 months; prior self-limited treatment with aspirin (i.e., not daily use) is not itself an exclusion.
- Grade ≥1 hematology lab abnormality for INR (>1.1 x ULN), hemoglobin (<10.0 g/L), platelets (<100,000 cells/μL), and WBC (2,500 cells/mm3)
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 |
|---|---|---|
| Edoxaban 30mg daily | Drug | Treatment |
| Matching placebo | Drug | Placebo |
Primary outcome
Change in Interleukin 6 (IL-6) Plasma Levels From Baseline to 4 Months.
Time frame: Through study completion, an average of 4 months on each treatment.
Difference between treatment and control ln-transformed IL-6 plasma levels in change from pre-treatment to on-treatment values
1 secondary outcome
Change in D-Dimer Levels From Baseline to 4 Months
Time frame: Through study completion, an average of 4 months on each treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jason Baker, M.D. principal investigator
Hennepin Healthcare Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Edoxaban 30mg daily in people with Inflammation and Coagulation, run by Hennepin Healthcare Research Institute at 2 sites 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 9 inclusion and 19 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: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 6 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Interleukin 6 (IL-6) Plasma Levels From Baseline to 4 Months. (time frame: Through study completion, an average of 4 months on each treatment.). 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 6 Sep 2019.