HIV InfectionPhase 1/2NCT02121756
Dipyridamole for Immune Activation in HIV
A Phase 1/2 study testing Dipyridamole in people with HIV Infection, run by Sharon Riddler at 1 site in United States.
Trial summary
The purpose of this study is to determine if Dipyridamole (DP) will decrease inflammation in HIV-1-infected individuals who are already on antiretroviral treatment and have a low viral load. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- Dipyridamole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Nov 2017
- Phase
- Phase 1/2
- 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-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.
- On ART for at least 12 months prior to study entry with a regimen that includes three or more antiretroviral medications. More information on this criterion is available in the protocol.
- Plasma HIV-1 RNA <50 copies/mL by any standard clinical assay at screening and for a minimum of 12 months prior to entry, confirmed by at least 2 measurements prior to study entry, one of which must be at least 48 weeks prior to study entry and one of which must be 61 days and 48 weeks prior to study entry. All plasma HIV-1 RNA measurements in the 12 months prior to study entry must be <50 copies/mL (with the exception that a single detectable measurement of ≤ 200 copies/mL is permitted if the RNA levels immediately before and after are <50 copies/mL).
- Stable ART regimen for at least 8 weeks prior to study entry and no plans to change ART regimen for at least 6 months following study entry.
- Ability and willingness to provide informed consent.
- In the opinion of the investigator, no medical, mental health or other condition that precludes participation.
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- Laboratory values obtained within 60 days prior to entry.
- Hemoglobin ≥10.0 g/dL
- Platelet count ≥100,000/mm3
- INR ≤ 1.5 (for rectal tissue subset only)
- PTT <2x ULN (for rectal tissue subset only)
- AST and ALT < 2.5 x upper limit of normal (ULN)
- Total bilirubin < 2.5 x ULN (except if hyperbilirubinemia is secondary to atazanavir).
- Creatinine ≤ 1.5 x ULN
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative (note: subject with HCV Ab positive is eligible if Hepatitis C RNA PCR (viral load) is undetectable)
- For females of reproductive potential, negative serum or urine pregnancy test at screening and within 72 hours prior to study entry. Females of reproductive potential include women who have not been post-menopausal for at least 24 consecutive months, (i.e., who have had menses within the preceding 24 months, or women who have not undergone surgical sterilization, specifically hysterectomy and/or bilateral oophorectomy).
- Females of reproductive potential who are participating in sexual activity that could lead to pregnancy must agree to use one method of acceptable contraception while receiving protocol-specified treatment and for 4 weeks after stopping the treatment. These methods include condoms (male or female) with or without a spermicidal agent; diaphragm or cervical cap with spermicide; intrauterine device (IUD); and hormone-based contraceptive.
- Females not of reproductive potential (girls who have not reached menarche, women who have been post-menopausal for at least 24 consecutive months, or women who have undergone surgical sterilization, e.g., hysterectomy, bilateral oophorectomy, or bilateral tubal ligation or salpingectomy) are eligible without requiring the use of a contraceptive. Self- report is acceptable documentation of sterilization, other contraceptive methods, and menopause.
- Rectal Tissue Subset only: Willing to abstain from receptive anal intercourse and practices involving insertion of anything in the rectum (drug, enema, penis, or sex toy) for 72 hours prior to rectal biopsy and for 7 days post-biopsy to minimize risk of bleeding complications.
Who cannot join
- Pregnancy or breast-feeding.
- Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation.
- Known cardiovascular disease (history of MI, coronary artery bypass graft surgery, percutaneous coronary intervention, stroke, transient ischemic attack, peripheral arterial disease with ABI <0.9 or claudication).
- Uncontrolled type II diabetes mellitus.
- Known chronic inflammatory conditions such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, sarcoidosis, inflammatory bowel disease (i.e., Crohn's disease or ulcerative colitis), chronic pancreatitis, or autoimmune hepatitis, myositis, or myopathy.
- History of asthma requiring medical treatment within 2 years prior to study entry with the exception of the use of albuterol inhaler for mild intermittent asthma.
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- Serious illness requiring systemic treatment and/or hospitalization within 14 days prior to entry.
- Use of any of the following medications for more than 3 consecutive days within the 60 days prior to study entry:
- Immunosuppressives (e.g., azathioprine, corticosteroids [physiologic replacement doses are allowed], cyclosporine, mycophenolate, NSAIDs (nonsteroidal anti-inflammatory drugs), sirolimus, sulfasalazine, tacrolimus)
- Immune modulators (e.g., cytokines [e.g., IL-2], granulocyte colony stimulating factor, growth hormone, tumor necrosis factor antagonists, thalidomide)
- Antineoplastic agents
- Anticoagulants (e.g., warfarin and heparin)
- Anti-platelet drugs (e.g., clopidogrel and aspirin)
- Vaccinations within 1 week prior to the pre-entry or study entry visits. Routine standard of care vaccinations including hepatitis A and/or B, influenza, pneumococcal, and tetanus are permitted if administered at least 7 days before pre-entry and entry evaluations.
- Participation on any HIV immunotherapy or therapeutic vaccination trials within 6 months prior to study entry.
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Use of investigational therapies within 30 days prior to study entry.
- Rectal Tissue Subset only:
- Abnormalities of the colorectal mucosa or significant colorectal symptom(s), which in the opinion of the study investigator represent a contraindication to biopsy (including but not limited to presence of any unresolved injury, infectious or inflammatory condition of the local mucosa, and presence of symptomatic external hemorrhoids.
- NOTE: Abnormalities of the colorectal mucosa will be assessed at the time of the enrollment flexible sigmoidoscopy. If no significant colorectal abnormalities or symptoms are present then the participant will undergo the enrollment procedures. If abnormalities are present then no biopsies will be performed and the participant will not be enrolled into the rectal tissue subset but will continue participation in the main study.
- Active untreated gonorrhea, or chlamydia infection within 30 days prior to study entry (subjects diagnosed with rectal gonorrhea or chlamydia infection at screening may be treated during the screening period provided the treatment is at least 30 days prior to entry).
- Exclusions for spirometry testing (for participants enrolled under Version 2.0) Participants will not undergo pre- and post-bronchodilator spirometry if they have any of the following: - Abdominal or cataract surgery within 3 months.
- Myocardial infarction or stroke within the past 3 months.
- Acute onset of shortness of breath, cough, fever or heart condition such as tachycardia, angina or arrhythmias with 4 weeks prior to enrollment.
- Increasing respiratory symptoms or febrile (temperature >100.4°F [38°C]) within 4 weeks of study entry.
- Uncontrolled hypertension defined as systolic > 160 mm Hg or diastolic > 100 mm Hg from an average of two or more readings. Participant with controlled hypertension may undergo spirometry.
- Prior history of adverse reaction to albuterol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pitt Treatment Evaluation Unit / University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Phase I/II Pilot Study of Dipyridamole as a Modulator of Immune Activation and Systemic Inflammation in HIV-1-Infected Subjects on Antiretroviral Therapy- DAIDS-ES ID 11987
The purpose of this study is to determine if Dipyridamole (DP) will decrease inflammation in HIV-1-infected individuals who are already on antiretroviral treatment and have a low viral load.
Read the detailed description
Background:
- Since HIV-infected individuals started taking anti-HIV medications, illnesses from AIDS have decreased, but other serious diseases have increased. Researchers think this may be caused by an increase in activity of the immune system that fights infection, leading to inflammation. Inflammation is a normal body reaction to any infection. However, if inflammation lasts a long time, like in HIV infection, it may lead to complications such as heart disease, cancer, liver disease, lung disease, and problems with thinking. Many HIV researchers are studying the harmful effects of this prolonged immune system activity and inflammation and possible ways to prevent these complications.
- A drug called dipyridamole is approved by the Food and Drug Administration (FDA) under the trade name Persantine® for use with other drugs to reduce the risk of blood clots after heart valve replacement. Laboratory studies have shown that dipyridamole also lowers the level of immune system activity and inflammation measured in the blood.
Objectives:
- To see how dipyridamole affects blood and lung tests to measure immune system activity and inflammation and to look at the safety and tolerability of dipyridamole in people infected with HIV. This use of dipyridamole is investigational, or not approved by the FDA; however, the dose to be used in this study, 100mg four times a day, is the dose approved by the FDA.
Eligibility:
- Individuals 18 years of age and older who have HIV infection and are taking medications to treat it, and have a low viral load (HIV-1 RNA <50 copies/mL) for a minimum of 12 months.
Design:
- Participants will be screened with a physical exam, blood test, and medical history. Women of reproductive age will also receive a pregnancy test.
- Participants will take either Dipyridamole or a placebo for 12 weeks. Then they will take Dipyridamole for 12 weeks.
- During the study, participants will have frequent blood and urine tests. Dipyridamole drug levels, and liver and kidney function tests will be performed. HIV viral load (the amount of virus in the blood) will also be studied.
- Participants will have a final follow-up visit after an additional 4 weeks.
- Four brachial artery ultrasound images will be taken.
- Four pre- and post-bronchodilator spirometry tests will be performed by participants enrolled under Version 2.0: after each pre-test spirometry, participants will be asked to inhale 4 puffs of albuterol, and then to repeat the spirometry for post-testing.
- Participants will receive rectal swabs at screening, and four flexible sigmoidoscopies with rectal biopsies of the sigmoid colon throughout the study. These studies of the lower colon and samples of the rectum will be used to explore the effects of Dipyridamole. Participants can, however, opt out of all rectal procedures.
- Conditions
- HIV Infection
- Being tested
- Dipyridamole, Placebo, then Dipyridamole
- Keywords
- Dipyridamole, HIV, Immune Markers, Immune Activation, Inflammation
- Medical subject headings
- HIV Infections, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DipyridamoleDrug
Also called Permole®, Persantine®
Dipyridamole 100 mg four (4) times daily for 24 weeks from Baseline to Week 24
Placebo, then DipyridamoleDrug
Also called Permole®, Persantine®
Placebo for Dipyridamole four (4) times daily for 12 weeks from Baseline to Week 12 followed by Dipyridamole 100mg four (4) times daily for 12 weeks from Week 12 to Week 24
| Study group | Role | What they receive |
|---|---|---|
| Dipyridamole | Experimental | ARM A: Dipyridamole 100 mg four (4) times daily for 24 weeks from Baseline to Week 24 Receives: Drug: Dipyridamole |
| Placebo then Dipyridamole | Active comparator | ARM B: Placebo for Dipyridamole four (4) times daily for 12 weeks from Baseline to Week 12 followed by Dipyridamole 100mg four (4) times daily for 12 weeks from Week 12 to Week 24 Receives: Drug: Placebo, then Dipyridamole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocyte and Macrophage Activation Assessed as Change in Plasma Levels of sCD14 From Baseline to Week 12
Change in plasma levels of sCD14 from baseline to week 12
Measured: Baseline to week 12
Monocyte and Macrophage Activation Assessed as Change in Plasma Levels of sCD163 From Baseline to Week 12
Change in Plasma levels of sCD163 from baseline to week 12
Measured: baseline to week 12
Systemic Inflammation Assessed as Change in IL-6 Plasma Levels From Baseline to Week 12
Change in Plasma levels of IL-6 from baseline to week 12
Measured: baseline to week 12
Secondary outcomes (12)
Immune System Activation as Measured by the Proportion of CD8+ T Cells Co-expressing CD69 and CD25 After 12 Weeks of Dipyridamole Treatment Compared to Placebo
To compare changes in the level of T cell immune activation as measured by the proportion of CD8+ T cells co-expressing CD69 and CD25 after 12 weeks of Dipyridamole treatment to placebo.
Measured: Baseline to week 12
Safety and Tolerability of Dipyridamole Assessed as the Number of Participants With Grade 2 or Higher Adverse Events or Treatment Discontinuations
Grade 2 or higher adverse events and treatment discontinuations
Measured: First 12 weeks of dipyridamole treatment
Immune System Activation Assessed as the Change in the Proportion of Cycling CD4+ T Cells as Measured by Ki-67 Expression at Baseline and After Treatment With Dipyridamole
To assess whether Dipyridamole reduces the proportion of cycling CD4+ T cells as measured by Ki-67 expression at baseline and after treatment with Dipyridamole.
Measured: Baseline to week 12
Immune System Activation as Measured by the Proportion of CD4+ T Cells Co-expressing HLA-DR and CD38 After 12 Weeks of Dipyridamole Treatment Compared to Placebo
To compare changes in the level of T cell immune activation as measured by the proportion of CD4+ T cells co-expressing HLA-DR and CD38 after 12 weeks of DP treatment to placebo.
Measured: Baseline to week 12
Immune System Activation as Measured by the Proportion of CD8+ T Cells Co-expressing HLA-DR and CD38 After 12 Weeks of Dipyridamole Treatment Compared to Placebo
To compare changes in the level of T cell immune activation as measured by the proportion of CD8+ T cells co-expressing HLA-DR and CD38 after 12 weeks of Dipyridamole treatment to placebo.
Measured: Baseline to week 12
Immune System Activation Assessed by the Proportion of CD4+ T Cells Co-expressing CD69 and CD25 After 12 Weeks of Dipyridamole Treatment to Placebo
To compare changes in the level of T cell immune activation as measured by the proportion of CD4+ T cells co-expressing CD69 and CD25 after 12 weeks of Dipyridamole treatment to placebo.
Measured: Baseline to week 12
Cellular Immune Activation: Change in the Proportion of Cycling CD8+ T Cells
To assess whether Dipyridamole reduces the proportion of cycling CD8+ T cells as measured by Ki-67 expression at baseline and after treatment with Dipyridamole.
Measured: Baseline to week 12
Systemic Inflammatory Biomarkers: Change in the Levels of sTNFαR
To compare changes in the levels of sTNFαR after 12 weeks of dipyridamole treatment to placebo
Measured: Baseline to week 12
Systemic Inflammatory Biomarkers: Change in the Levels of TNFα
To compare changes in the levels of TNFα after 12 weeks of dipyridamole treatment to placebo
Measured: Baseline to week 12
Systemic Inflammatory Biomarkers: Change in the Levels of hsCRP
To compare changes in the levels of hsCRP after 12 weeks of dipyridamole treatment to placebo
Measured: Baseline to week 12
Coagulation Biomarkers: Change in the Levels of D-dimer
To compare changes in the levels of D-dimer after 12 weeks of dipyridamole treatment to placebo
Measured: Baseline to week 12
Changes in Brachial Artery Flow-mediated Dilation (FMD)
To compare % change at tmax in brachial artery flow-mediated dilation (FMD) after 12 weeks of dipyridamole treatment to placebo
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2017
- Study completionNov 2017
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 HIV InfectionStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharon Riddler
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sharon Riddler, University of Pittsburgh
- Investigators
- Sharon A. Riddler, MD, MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121756
- Sponsor's protocol ID
- DAIDS-ES ID 11987
- Other IDs
- U01AI110410
- Status last verified
- Mar 2019
- First submitted
- 21 Apr 2014
- Last updated
- 11 Apr 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 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Pilot Study of Dipyridamole as a Modulator of Immune Activation and Systemic Inflammation in HIV-1-Infected Subjects on Antiretroviral Therapy- DAIDS-ES ID 11987
- ClinicalTrials.gov ID
- NCT02121756
- Acronym / sponsor ID
- DAIDS-ES ID 11987
- Conditions
- HIV Infection
- Keywords
- Dipyridamole, HIV, Immune Markers, Immune Activation, Inflammation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sharon RiddlerUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jul 2014
- Primary completion
- Oct 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Posted 11 Apr 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 determine if Dipyridamole (DP) will decrease inflammation in HIV-1-infected individuals who are already on antiretroviral treatment and have a low viral load.
Detailed description
Background:
- Since HIV-infected individuals started taking anti-HIV medications, illnesses from AIDS have decreased, but other serious diseases have increased. Researchers think this may be caused by an increase in activity of the immune system that fights infection, leading to inflammation. Inflammation is a normal body reaction to any infection. However, if inflammation lasts a long time, like in HIV infection, it may lead to complications such as heart disease, cancer, liver disease, lung disease, and problems with thinking. Many HIV researchers are studying the harmful effects of this prolonged immune system activity and inflammation and possible ways to prevent these complications.
- A drug called dipyridamole is approved by the Food and Drug Administration (FDA) under the trade name Persantine® for use with other drugs to reduce the risk of blood clots after heart valve replacement. Laboratory studies have shown that dipyridamole also lowers the level of immune system activity and inflammation measured in the blood.
Objectives:
- To see how dipyridamole affects blood and lung tests to measure immune system activity and inflammation and to look at the safety and tolerability of dipyridamole in people infected with HIV. This use of dipyridamole is investigational, or not approved by the FDA; however, the dose to be used in this study, 100mg four times a day, is the dose approved by the FDA.
Eligibility:
- Individuals 18 years of age and older who have HIV infection and are taking medications to treat it, and have a low viral load (HIV-1 RNA <50 copies/mL) for a minimum of 12 months.
Design:
- Participants will be screened with a physical exam, blood test, and medical history. Women of reproductive age will also receive a pregnancy test.
- Participants will take either Dipyridamole or a placebo for 12 weeks. Then they will take Dipyridamole for 12 weeks.
- During the study, participants will have frequent blood and urine tests. Dipyridamole drug levels, and liver and kidney function tests will be performed. HIV viral load (the amount of virus in the blood) will also be studied.
- Participants will have a final follow-up visit after an additional 4 weeks.
- Four brachial artery ultrasound images will be taken.
- Four pre- and post-bronchodilator spirometry tests will be performed by participants enrolled under Version 2.0: after each pre-test spirometry, participants will be asked to inhale 4 puffs of albuterol, and then to repeat the spirometry for post-testing.
- Participants will receive rectal swabs at screening, and four flexible sigmoidoscopies with rectal biopsies of the sigmoid colon throughout the study. These studies of the lower colon and samples of the rectum will be used to explore the effects of Dipyridamole. Participants can, however, opt out of all rectal procedures.
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 |
|---|---|---|
| Dipyridamole | Experimental | Drug: DipyridamoleARM A: Dipyridamole 100 mg four (4) times daily for 24 weeks from Baseline to Week 24 |
| Placebo then Dipyridamole | Active comparator | Drug: Placebo, then DipyridamoleARM B: Placebo for Dipyridamole four (4) times daily for 12 weeks from Baseline to Week 12 followed by Dipyridamole 100mg four (4) times daily for 12 weeks from Week 12 to Week 24 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.
- On ART for at least 12 months prior to study entry with a regimen that includes three or more antiretroviral medications. More information on this criterion is available in the protocol.
- Plasma HIV-1 RNA <50 copies/mL by any standard clinical assay at screening and for a minimum of 12 months prior to entry, confirmed by at least 2 measurements prior to study entry, one of which must be at least 48 weeks prior to study entry and one of which must be 61 days and 48 weeks prior to study entry. All plasma HIV-1 RNA measurements in the 12 months prior to study entry must be <50 copies/mL (with the exception that a single detectable measurement of ≤ 200 copies/mL is permitted if the RNA levels immediately before and after are <50 copies/mL).
- Stable ART regimen for at least 8 weeks prior to study entry and no plans to change ART regimen for at least 6 months following study entry.
- Ability and willingness to provide informed consent.
Key exclusion criteria (27 listed)
- Pregnancy or breast-feeding.
- Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation.
- Known cardiovascular disease (history of MI, coronary artery bypass graft surgery, percutaneous coronary intervention, stroke, transient ischemic attack, peripheral arterial disease with ABI <0.9 or claudication).
- Uncontrolled type II diabetes mellitus.
- Known chronic inflammatory conditions such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, sarcoidosis, inflammatory bowel disease (i.e., Crohn's disease or ulcerative colitis), chronic pancreatitis, or autoimmune hepatitis, myositis, or myopathy.
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 |
|---|---|---|
| DipyridamoleAlso: Permole®, Persantine®Dipyridamole 100 mg four (4) times daily for 24 weeks from Baseline to Week 24 | Drug | Dipyridamole |
| Placebo, then DipyridamoleAlso: Permole®, Persantine®Placebo for Dipyridamole four (4) times daily for 12 weeks from Baseline to Week 12 followed by Dipyridamole 100mg four (4) times daily for 12 weeks from Week 12 to Week 24 | Drug | Placebo then Dipyridamole |
Primary outcome
Monocyte and Macrophage Activation Assessed as Change in Plasma Levels of sCD14 From Baseline to Week 12
Time frame: Baseline to week 12
Change in plasma levels of sCD14 from baseline to week 12
Monocyte and Macrophage Activation Assessed as Change in Plasma Levels of sCD163 From Baseline to Week 12
Time frame: baseline to week 12
Change in Plasma levels of sCD163 from baseline to week 12
Systemic Inflammation Assessed as Change in IL-6 Plasma Levels From Baseline to Week 12
Time frame: baseline to week 12
Change in Plasma levels of IL-6 from baseline to week 12
12 secondary outcomes
Immune System Activation as Measured by the Proportion of CD8+ T Cells Co-expressing CD69 and CD25 After 12 Weeks of Dipyridamole Treatment Compared to Placebo
Time frame: Baseline to week 12
Safety and Tolerability of Dipyridamole Assessed as the Number of Participants With Grade 2 or Higher Adverse Events or Treatment Discontinuations
Time frame: First 12 weeks of dipyridamole treatment
Immune System Activation Assessed as the Change in the Proportion of Cycling CD4+ T Cells as Measured by Ki-67 Expression at Baseline and After Treatment With Dipyridamole
Time frame: Baseline to week 12
Immune System Activation as Measured by the Proportion of CD4+ T Cells Co-expressing HLA-DR and CD38 After 12 Weeks of Dipyridamole Treatment Compared to Placebo
Time frame: Baseline to week 12
Immune System Activation as Measured by the Proportion of CD8+ T Cells Co-expressing HLA-DR and CD38 After 12 Weeks of Dipyridamole Treatment Compared to Placebo
Time frame: Baseline to week 12
Immune System Activation Assessed by the Proportion of CD4+ T Cells Co-expressing CD69 and CD25 After 12 Weeks of Dipyridamole Treatment to Placebo
Time frame: Baseline to week 12
Cellular Immune Activation: Change in the Proportion of Cycling CD8+ T Cells
Time frame: Baseline to week 12
Systemic Inflammatory Biomarkers: Change in the Levels of sTNFαR
Time frame: Baseline to week 12
Systemic Inflammatory Biomarkers: Change in the Levels of TNFα
Time frame: Baseline to week 12
Systemic Inflammatory Biomarkers: Change in the Levels of hsCRP
Time frame: Baseline to week 12
Coagulation Biomarkers: Change in the Levels of D-dimer
Time frame: Baseline to week 12
Changes in Brachial Artery Flow-mediated Dilation (FMD)
Time frame: Baseline to week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 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.
Sharon A. Riddler, MD, MPH principal investigator
University of Pittsburgh
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 Dipyridamole in people with HIV Infection, run by Sharon Riddler 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 20 inclusion and 27 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 11 Apr 2019. 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. 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?
Yes. Results are posted in the registry (first posted 11 Apr 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?
Monocyte and Macrophage Activation Assessed as Change in Plasma Levels of sCD14 From Baseline to Week 12 (time frame: Baseline to week 12). The study lists 3 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 11 Apr 2019.