Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
121 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-08-31
Study Completion Date
2015-07-31
Brief Summary
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Since people started taking HIV medications, illness from AIDS has decreased, but other serious diseases like heart disease, cancer, and kidney, and liver disease have increased. HIV causes inflammation (irritation) inside the body that cannot be felt but can be measured by blood. Inflammation can lead to diseases that have become some of the leading causes of death in people with HIV. HIV therapy can partially lower levels of inflammation measured in blood, however, levels of inflammation in people who have HIV may remain high compared with people not infected with HIV.
Aspirin is a drug that is commonly used for pain relief but is also approved by the Food and Drug Administration (FDA) for preventing heart attacks and stroke in those who are at increased risk for heart attack and stroke. Aspirin also is used (but is not approved by the FDA) to decrease the risk of some cancers in people who are at increased risk. Aspirin is thought to decrease risk of heart attack and stroke because it blocks the activation of platelets and prevents blood clots from clogging narrowed blood vessels, a disease called atherosclerosis. It is unknown how aspirin might decrease the chance of developing cancer in some people at higher risk, but aspirin has been shown to modulate (or change) the immune system. In HIV-infected people who have been taking antiretroviral therapy and have an undetectable HIV viral load it was recently shown that low-dose aspirin 81 mg (baby aspirin), given for one week, lowers platelet activation and reduces blood markers of inflammation which may improve the function of the immune system.
The purpose of this study was to evaluate whether aspirin improves inflammation and immune activation when compared to a placebo (inactive medication like a dummy pill) and to determine if 12 weeks of aspirin 300 mg and aspirin 100 mg is safe for HIV-infected persons on antiretroviral therapy. Additionally, it studied whether a higher dose and longer duration of aspirin provides further anti-inflammatory and immune-modulating benefit. This was done using blood and urine tests that measure inflammation and also with a test that uses ultrasound to measure the flow of blood in your arm, called flow-mediated vasodilation (FMD) of the brachial artery (BART). This is a painless test that bounces sound waves off of a blood vessel in your arm.
Aspirin is a drug that is commonly used for pain relief but is also approved by the Food and Drug Administration (FDA) for preventing heart attacks and stroke in those who are at increased risk for heart attack and stroke. Aspirin also is used (but is not approved by the FDA) to decrease the risk of some cancers in people who are at increased risk. Aspirin is thought to decrease risk of heart attack and stroke because it blocks the activation of platelets and prevents blood clots from clogging narrowed blood vessels, a disease called atherosclerosis. It is unknown how aspirin might decrease the chance of developing cancer in some people at higher risk, but aspirin has been shown to modulate (or change) the immune system. In HIV-infected people who have been taking antiretroviral therapy and have an undetectable HIV viral load it was recently shown that low-dose aspirin 81 mg (baby aspirin), given for one week, lowers platelet activation and reduces blood markers of inflammation which may improve the function of the immune system.
The purpose of this study was to evaluate whether aspirin improves inflammation and immune activation when compared to a placebo (inactive medication like a dummy pill) and to determine if 12 weeks of aspirin 300 mg and aspirin 100 mg is safe for HIV-infected persons on antiretroviral therapy. Additionally, it studied whether a higher dose and longer duration of aspirin provides further anti-inflammatory and immune-modulating benefit. This was done using blood and urine tests that measure inflammation and also with a test that uses ultrasound to measure the flow of blood in your arm, called flow-mediated vasodilation (FMD) of the brachial artery (BART). This is a painless test that bounces sound waves off of a blood vessel in your arm.
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Detailed Description
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This was a phase II prospective, double-blind, randomized, placebo-controlled 3-arm clinical trial to study whether aspirin improves inflammation and immune activation. At study entry, participants were randomized between the three study arms: aspirin 300 mg, aspirin 100 mg and placebo. The study treatment duration was 12 weeks, followed by a 4 week washout period. The study duration was 16 weeks.
The study clinic visits included pre-entry (within 7 days prior to entry), entry, on treatment visits at weeks 2, 11 and 12, and final study visit at the end of the wash-out period at week 16. The samples for the primary and secondary outcomes were collected at pre-entry, entry, and weeks 2, 11 and 12. The evaluations of safety (clinical assessment for signs and symptoms, diagnoses, laboratory tests) were done at entry and weeks 2, 11, 12 and 16.
The co-primary objectives used pair-wise comparisons to assess the effects of 300 mg and 100 mg of daily aspirin for 12 weeks on plasma sCD14 levels.
The study clinic visits included pre-entry (within 7 days prior to entry), entry, on treatment visits at weeks 2, 11 and 12, and final study visit at the end of the wash-out period at week 16. The samples for the primary and secondary outcomes were collected at pre-entry, entry, and weeks 2, 11 and 12. The evaluations of safety (clinical assessment for signs and symptoms, diagnoses, laboratory tests) were done at entry and weeks 2, 11, 12 and 16.
The co-primary objectives used pair-wise comparisons to assess the effects of 300 mg and 100 mg of daily aspirin for 12 weeks on plasma sCD14 levels.
Conditions
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HIV-1 Infection
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Caregivers
Study Groups
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Aspirin 300 mg + aspirin 100 mg placebo
At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Group Type
ACTIVE_COMPARATOR
Aspirin
Intervention Type
DRUG
Aspirin is a nonsteroidal antiinflammatory drug (NSAID) effective in treating fever, pain, and inflammation in the body.
Placebo
Intervention Type
DRUG
Placebo for aspirin
Aspirin 100 mg + aspirin 300 mg placebo
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.
Group Type
ACTIVE_COMPARATOR
Aspirin
Intervention Type
DRUG
Aspirin is a nonsteroidal antiinflammatory drug (NSAID) effective in treating fever, pain, and inflammation in the body.
Placebo
Intervention Type
DRUG
Placebo for aspirin
Aspirin 300 mg + aspirin 100 mg placebos
At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Placebo for aspirin
Interventions
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Aspirin
Aspirin is a nonsteroidal antiinflammatory drug (NSAID) effective in treating fever, pain, and inflammation in the body.
Intervention Type
DRUG
Placebo
Placebo for aspirin
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* HIV-1 infection.
* Currently on continuous ART for ≥48 weeks prior to study entry. NOTE: This is defined as continuous active therapy with no treatment interruption longer than 7 consecutive days and a total duration off-treatment of no more than 14 days during the 48 weeks prior to entry.
* No change in ART regimen within the 12 weeks prior to study entry (except as noted below).
NOTE: Modifications of ART dosing during within the 12 weeks prior to entry are permitted. In addition, the change in formulation (eg, from standard formulation to fixed dose combination or single tablet regimen) or dosing (eg, from once a day to twice a day) is allowed within 12 weeks prior to entry. Within-class single drug substitution (eg, switch from nevirapine to efavirenz or from atazanavir to darunavir), are not allowed within 12 weeks prior to entry. No other changes in ART in the 12 weeks prior to entry are permitted.
* Screening HIV-1 RNA must be \<50 copies/mL and performed by any FDA-approved assay at any US laboratory that has a CLIA certification or its equivalent within 45 days prior to study entry.
* Maintain ART-mediated viral suppression for at least 48 weeks prior to study entry defined as:
A. At least one HIV-1 RNA test result obtained at any time point greater than 48 weeks prior to study entry must be BLQ and must be performed by any FDA-approved assay at a CLIA-certified laboratory or its equivalent.
AND
B. All HIV-1 RNA tests reported during the 48 weeks prior to study entry must be BLQ and must be performed by any FDA-approved assay at a CLIA-certified laboratory or its equivalent.
NOTE: A single RNA "blip" of ≤500 copies/mL is permissible if RNA levels most recent before and after (may include the screening HIV-1 RNA test) are below the level of quantification (BLQ) for the assay. If the RNA level after the blip is the screening HIV-1 RNA test, the result must be \<50 copies/mL.
* The following laboratory values obtained within 45 days prior to study entry by any US laboratory that has a CLIA certification or its equivalent.
* Absolute neutrophil count (ANC) ≥750/mm\^3
* Hemoglobin ≥9.0 g/dL for female subjects and ≥10.0 g/dL for male subjects
* Platelet count \>100,000/mm\^3
* Prothrombin time (PT) \<1.2 x upper limit normal (ULN)
* Partial thromboplastin time (PTT) \<1.5 x ULN
* Calculated creatinine clearance (CrCl) ≥30 mL/min, as estimated by the Cockroft-Gault formula NOTE: Calculation for the Cockcroft-Gault equation is available at https://www.fstrf.org/apps/cfmx/apps/common/Portal/index.cfm
* Aspartate aminotransferase (AST) (SGOT) ≤2 x ULN.
* Alanine aminotransferase (ALT) (SGPT) ≤2 x ULN.
* Alkaline phosphatase ≤2 x ULN.
* Total bilirubin ≤2.5 x ULN. If the subject if taking an indinavir- or atazanavir-containing regimen at the time of screening, a total bilirubin of ≤5 x ULN is acceptable.
* Female study volunteers of reproductive potential (pre-menopausal women who have not had a sterilization procedure (eg, hysterectomy, bilateral oophorectomy, tubal ligation, or salpingectomy) must have a negative serum or urine pregnancy test performed within 24 hours prior to study entry. Women are considered menopausal if they have not had a menses for at least 12 months and have a FSH (follicle stimulating hormone) of greater than 40 IU/L or, if FSH testing is not available, they have had amenorrhea for 24 consecutive months.
If the female volunteer is not of reproductive potential (women who are menopausal, defined as not having had a menses for at least 12 months with an FSH of greater than 40 IU/L, or if FSH testing is not available, have had amenorrhea for 24 consecutive months, or women who have undergone surgical sterilization, (eg, hysterectomy, bilateral oophorectomy, tubal ligation or salpingectomy)), she is eligible without requiring the use of a contraceptive method. Acceptable documentation of sterilization is subject reported history of hysterectomy, bilateral oophorectomy, tubal ligation, tubal micro-insert, menopause, or the partner with vasectomy/azoospermia.
\- If participating in sexual activity that could lead to pregnancy, the female study volunteer must be willing to use contraception while receiving protocol-specified medication(s) and for the washout period of 4 weeks. At least one of the following methods MUST be used:
* Condoms (male or female), with or without a spermicidal agent
* Diaphragm or cervical cap with spermicide
* Intrauterine device (IUD)
* Hormone-based contraceptive
As hormone-based contraceptives (oral, transdermal, or subdermal) can affect coagulopathy biomarkers, subjects who plan on using such a contraceptive during the study must be taking the same product for ≥4 weeks prior to screening and be encouraged to continue throughout the duration of the study, if medically feasible.
* No documented opportunistic infections within 24 weeks prior to study entry
* Karnofsky performance score \>/= 70 within 45 days prior to study entry
* Ability and willingness of subject or legal guardian/representative to provide written informed consent.
* Willingness to refrain from the use of aspirin or any aspirin-related product (other than the study drug), including NSAIDs, from time of screening visit through the end of the 16 week trial.
NOTE: Acetaminophen-based products may be used before and during the trial when analgesics are required.
* Completion of the pre-entry FMD assessment NOTE: The FMD must be performed at the site and confirmed as acceptable by the University of Wisconsin Atherosclerosis Imaging Research Program (UW AIRP) core lab prior to study entry.
* Confirmation of the availability of the stored pre-entry fasting specimens (plasma and serum); the site must confirm that these specimens have been entered into the Laboratory Data Management System (LDMS).
* Currently on continuous ART for ≥48 weeks prior to study entry. NOTE: This is defined as continuous active therapy with no treatment interruption longer than 7 consecutive days and a total duration off-treatment of no more than 14 days during the 48 weeks prior to entry.
* No change in ART regimen within the 12 weeks prior to study entry (except as noted below).
NOTE: Modifications of ART dosing during within the 12 weeks prior to entry are permitted. In addition, the change in formulation (eg, from standard formulation to fixed dose combination or single tablet regimen) or dosing (eg, from once a day to twice a day) is allowed within 12 weeks prior to entry. Within-class single drug substitution (eg, switch from nevirapine to efavirenz or from atazanavir to darunavir), are not allowed within 12 weeks prior to entry. No other changes in ART in the 12 weeks prior to entry are permitted.
* Screening HIV-1 RNA must be \<50 copies/mL and performed by any FDA-approved assay at any US laboratory that has a CLIA certification or its equivalent within 45 days prior to study entry.
* Maintain ART-mediated viral suppression for at least 48 weeks prior to study entry defined as:
A. At least one HIV-1 RNA test result obtained at any time point greater than 48 weeks prior to study entry must be BLQ and must be performed by any FDA-approved assay at a CLIA-certified laboratory or its equivalent.
AND
B. All HIV-1 RNA tests reported during the 48 weeks prior to study entry must be BLQ and must be performed by any FDA-approved assay at a CLIA-certified laboratory or its equivalent.
NOTE: A single RNA "blip" of ≤500 copies/mL is permissible if RNA levels most recent before and after (may include the screening HIV-1 RNA test) are below the level of quantification (BLQ) for the assay. If the RNA level after the blip is the screening HIV-1 RNA test, the result must be \<50 copies/mL.
* The following laboratory values obtained within 45 days prior to study entry by any US laboratory that has a CLIA certification or its equivalent.
* Absolute neutrophil count (ANC) ≥750/mm\^3
* Hemoglobin ≥9.0 g/dL for female subjects and ≥10.0 g/dL for male subjects
* Platelet count \>100,000/mm\^3
* Prothrombin time (PT) \<1.2 x upper limit normal (ULN)
* Partial thromboplastin time (PTT) \<1.5 x ULN
* Calculated creatinine clearance (CrCl) ≥30 mL/min, as estimated by the Cockroft-Gault formula NOTE: Calculation for the Cockcroft-Gault equation is available at https://www.fstrf.org/apps/cfmx/apps/common/Portal/index.cfm
* Aspartate aminotransferase (AST) (SGOT) ≤2 x ULN.
* Alanine aminotransferase (ALT) (SGPT) ≤2 x ULN.
* Alkaline phosphatase ≤2 x ULN.
* Total bilirubin ≤2.5 x ULN. If the subject if taking an indinavir- or atazanavir-containing regimen at the time of screening, a total bilirubin of ≤5 x ULN is acceptable.
* Female study volunteers of reproductive potential (pre-menopausal women who have not had a sterilization procedure (eg, hysterectomy, bilateral oophorectomy, tubal ligation, or salpingectomy) must have a negative serum or urine pregnancy test performed within 24 hours prior to study entry. Women are considered menopausal if they have not had a menses for at least 12 months and have a FSH (follicle stimulating hormone) of greater than 40 IU/L or, if FSH testing is not available, they have had amenorrhea for 24 consecutive months.
If the female volunteer is not of reproductive potential (women who are menopausal, defined as not having had a menses for at least 12 months with an FSH of greater than 40 IU/L, or if FSH testing is not available, have had amenorrhea for 24 consecutive months, or women who have undergone surgical sterilization, (eg, hysterectomy, bilateral oophorectomy, tubal ligation or salpingectomy)), she is eligible without requiring the use of a contraceptive method. Acceptable documentation of sterilization is subject reported history of hysterectomy, bilateral oophorectomy, tubal ligation, tubal micro-insert, menopause, or the partner with vasectomy/azoospermia.
\- If participating in sexual activity that could lead to pregnancy, the female study volunteer must be willing to use contraception while receiving protocol-specified medication(s) and for the washout period of 4 weeks. At least one of the following methods MUST be used:
* Condoms (male or female), with or without a spermicidal agent
* Diaphragm or cervical cap with spermicide
* Intrauterine device (IUD)
* Hormone-based contraceptive
As hormone-based contraceptives (oral, transdermal, or subdermal) can affect coagulopathy biomarkers, subjects who plan on using such a contraceptive during the study must be taking the same product for ≥4 weeks prior to screening and be encouraged to continue throughout the duration of the study, if medically feasible.
* No documented opportunistic infections within 24 weeks prior to study entry
* Karnofsky performance score \>/= 70 within 45 days prior to study entry
* Ability and willingness of subject or legal guardian/representative to provide written informed consent.
* Willingness to refrain from the use of aspirin or any aspirin-related product (other than the study drug), including NSAIDs, from time of screening visit through the end of the 16 week trial.
NOTE: Acetaminophen-based products may be used before and during the trial when analgesics are required.
* Completion of the pre-entry FMD assessment NOTE: The FMD must be performed at the site and confirmed as acceptable by the University of Wisconsin Atherosclerosis Imaging Research Program (UW AIRP) core lab prior to study entry.
* Confirmation of the availability of the stored pre-entry fasting specimens (plasma and serum); the site must confirm that these specimens have been entered into the Laboratory Data Management System (LDMS).
Exclusion Criteria
\- Current malignancy (except non-melanoma cancer of the skin not requiring systemic chemotherapy or radiation therapy).
NOTE: Carcinoma in situ of the cervix or anus is not considered exclusionary.
* Prior history of malignancy if the subject is not disease free for 24 or more weeks prior to study entry.
* Current use or indication for use of non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin that cannot be interrupted for clinical reasons. Examples of clinical reasons include, but are not limited to, known and documented 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).
* Current diagnosis of diabetes with HbA1c ≥8% within 24 weeks prior to screening.
* Changes in lipid-lowering or antihypertensive medication within 90 days prior to study entry or expected need to modify these medications during the study.
NOTE: Lipid-lowering medication includes: statins, fibrates, niacin (dose ≥250 mg daily), and fish-oil/omega 3 fatty acids (dose \>1000 mg of marine oils daily).
* Known cirrhosis
* Known chronic active hepatitis B NOTE: Active hepatitis B is defined as hepatitis B surface antigen positive and hepatitis B DNA positive within 24 weeks prior to study entry; subjects with hepatitis B virus (HBV) DNA BLQ for greater than 24 weeks prior to study entry are eligible.
* Known chronic active hepatitis C NOTE: Active hepatitis C is defined as a detectable plasma HCV RNA level within 24 weeks prior to study entry; subjects with HCV RNA BLQ for greater than 24 weeks prior to study entry are eligible.
* Known inflammatory conditions, such as, but not limited to, rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), sarcoidosis, inflammatory bowel disease (IBD), chronic pancreatitis, autoimmune hepatitis, Adult Stills disease, Rheumatic heart disease, bursitis.
* Breastfeeding or pregnant
* Previous intolerance or allergy to aspirin or any aspirin products.
* Frequent use of aspirin or aspirin products (NSAIDs), defined as an average of 2 or more times per week in the last 12 weeks prior to study entry.
* Immunosuppressant use, such as, but not limited to, systemic or potentially systemic glucocorticoids (including injected, ie, intra-articular, nasal or inhaled steroids), azathioprine, tacrolimus, mycophenolate, sirolimus, rapamycin, methotrexate, or cyclosporine within 45 days prior to study entry.
* Use of any systemic antineoplastic or immunomodulatory treatment, investigational vaccines, interleukins, interferons, growth factors, or intravenous immunoglobulin (IVIG) within 45 days prior to study entry.
NOTE: Routine standard of care, including hepatitis A and/or B, human papilloma virus, influenza, pneumococcal, and tetanus vaccines are permitted if administered at least 7 days before study entry and before biomarker/peripheral blood mononuclear cell (PBMC) blood collections.
* Concurrent use of prohibited medications as per section 5.4
* Heavy alcohol use as defined by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) http://www.niaaa.nih.gov/alcohol-health/overview-alcohol-consumption/moderate-binge-drinking
* Alcohol or drug use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
* Current use of anticoagulation therapy or conditions requiring use of anticoagulants, use such as, but not limited to warfarin (Coumadin), rivaroxaban (Xarelto), clopidogrel (Plavix), dabigatran (Pradaxa), apixaban (Eliquis), heparin, ticlopidine (Ticlid), Presugrel (Effient).
* History of coagulopathy, deep venous thrombosis, pulmonary embolism.
* Known active or recent (not fully resolved within 4 weeks prior to study entry) invasive bacterial, fungal, parasitic, or viral infections.
NOTE: Recurrent herpes simplex virus (HSV) is not exclusionary. Subjects on antiviral prophylaxis for HSV or VZV are encouraged to remain on treatment for the duration of the study if medically feasible.
* Serious illness or trauma requiring systemic treatment and/or hospitalization within 4 weeks prior to study entry.
* History of bleeding conditions such as peptic ulcer disease, hemophilia, von Willebrand disease, idiopathic thrombocytopenic purpura.
* History of thrombotic disorders such as protein C or S deficiency.
* History of gastrointestinal (GI) bleeding within the past 6 months prior to study entry.
* History of intracranial hemorrhage.
NOTE: Carcinoma in situ of the cervix or anus is not considered exclusionary.
* Prior history of malignancy if the subject is not disease free for 24 or more weeks prior to study entry.
* Current use or indication for use of non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin that cannot be interrupted for clinical reasons. Examples of clinical reasons include, but are not limited to, known and documented 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).
* Current diagnosis of diabetes with HbA1c ≥8% within 24 weeks prior to screening.
* Changes in lipid-lowering or antihypertensive medication within 90 days prior to study entry or expected need to modify these medications during the study.
NOTE: Lipid-lowering medication includes: statins, fibrates, niacin (dose ≥250 mg daily), and fish-oil/omega 3 fatty acids (dose \>1000 mg of marine oils daily).
* Known cirrhosis
* Known chronic active hepatitis B NOTE: Active hepatitis B is defined as hepatitis B surface antigen positive and hepatitis B DNA positive within 24 weeks prior to study entry; subjects with hepatitis B virus (HBV) DNA BLQ for greater than 24 weeks prior to study entry are eligible.
* Known chronic active hepatitis C NOTE: Active hepatitis C is defined as a detectable plasma HCV RNA level within 24 weeks prior to study entry; subjects with HCV RNA BLQ for greater than 24 weeks prior to study entry are eligible.
* Known inflammatory conditions, such as, but not limited to, rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), sarcoidosis, inflammatory bowel disease (IBD), chronic pancreatitis, autoimmune hepatitis, Adult Stills disease, Rheumatic heart disease, bursitis.
* Breastfeeding or pregnant
* Previous intolerance or allergy to aspirin or any aspirin products.
* Frequent use of aspirin or aspirin products (NSAIDs), defined as an average of 2 or more times per week in the last 12 weeks prior to study entry.
* Immunosuppressant use, such as, but not limited to, systemic or potentially systemic glucocorticoids (including injected, ie, intra-articular, nasal or inhaled steroids), azathioprine, tacrolimus, mycophenolate, sirolimus, rapamycin, methotrexate, or cyclosporine within 45 days prior to study entry.
* Use of any systemic antineoplastic or immunomodulatory treatment, investigational vaccines, interleukins, interferons, growth factors, or intravenous immunoglobulin (IVIG) within 45 days prior to study entry.
NOTE: Routine standard of care, including hepatitis A and/or B, human papilloma virus, influenza, pneumococcal, and tetanus vaccines are permitted if administered at least 7 days before study entry and before biomarker/peripheral blood mononuclear cell (PBMC) blood collections.
* Concurrent use of prohibited medications as per section 5.4
* Heavy alcohol use as defined by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) http://www.niaaa.nih.gov/alcohol-health/overview-alcohol-consumption/moderate-binge-drinking
* Alcohol or drug use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
* Current use of anticoagulation therapy or conditions requiring use of anticoagulants, use such as, but not limited to warfarin (Coumadin), rivaroxaban (Xarelto), clopidogrel (Plavix), dabigatran (Pradaxa), apixaban (Eliquis), heparin, ticlopidine (Ticlid), Presugrel (Effient).
* History of coagulopathy, deep venous thrombosis, pulmonary embolism.
* Known active or recent (not fully resolved within 4 weeks prior to study entry) invasive bacterial, fungal, parasitic, or viral infections.
NOTE: Recurrent herpes simplex virus (HSV) is not exclusionary. Subjects on antiviral prophylaxis for HSV or VZV are encouraged to remain on treatment for the duration of the study if medically feasible.
* Serious illness or trauma requiring systemic treatment and/or hospitalization within 4 weeks prior to study entry.
* History of bleeding conditions such as peptic ulcer disease, hemophilia, von Willebrand disease, idiopathic thrombocytopenic purpura.
* History of thrombotic disorders such as protein C or S deficiency.
* History of gastrointestinal (GI) bleeding within the past 6 months prior to study entry.
* History of intracranial hemorrhage.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Sponsor Role
collaborator
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
NETWORK
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Judith A Aberg, MD
Role: STUDY_CHAIR
Icahn School of Medicine at Mount Sinai
Meagan O'Brien, MD
Role: STUDY_CHAIR
Icahn School of Medicine at Mount Sinai
Locations
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601 University of California, Los Angeles CARE Center CRS
Los Angeles, California, United States
Site Status
701 University of California, San Diego AntiViral Research Center CRS
San Diego, California, United States
Site Status
Ucsf Aids Crs (801)
San Francisco, California, United States
Site Status
Harbor-UCLA Med. Ctr. CRS (603)
Torrance, California, United States
Site Status
University of Colorado Hospital CRS (6101)
Aurora, Colorado, United States
Site Status
2701 Northwestern University CRS
Chicago, Illinois, United States
Site Status
Rush Univ. Med. Ctr. ACTG CRS (2702)
Chicago, Illinois, United States
Site Status
Massachusetts General Hospital ACTG CRS (101)
Boston, Massachusetts, United States
Site Status
Brigham and Women's Hosp. ACTG CRS (107)
Boston, Massachusetts, United States
Site Status
3201 Chapel Hill CRS
Chapel Hill, North Carolina, United States
Site Status
Greensboro CRS (3203)
Greensboro, North Carolina, United States
Site Status
Univ. of Cincinnati CRS (2401)
Cincinnati, Ohio, United States
Site Status
Case CRS (2501)
Cleveland, Ohio, United States
Site Status
3652 Vanderbilt Therapeutics (VT) CRS
Nashville, Tennessee, United States
Site Status
Houston AIDS Research Team CRS (31473)
Houston, Texas, United States
Site Status
Countries
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United States
Related Links
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http://rsc.tech-res.com/clinical-research-sites/safety-reporting/manual
Version 2.0 of the DAIDS EAE Manual
http://rsc.tech-res.com/clinical-research-sites/safety-reporting/daids-grading-tables
DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009),
Other Identifiers
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ACTG A5331
Identifier Type: -
Identifier Source: org_study_id
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NCT00422695
COMPLETED
Analysis of Genetic Factors Which May Influence the Course of HIV Infection
NCT00159068
COMPLETED
Analysis of HIV-1 Replication During Antiretroviral Therapy
NCT00767312
ENROLLING_BY_INVITATION
Impact of Antiretroviral Therapy on Cardiac Biomarkers
NCT00641888
COMPLETED
Studies of the Pathogenesis of HIV Infection in Human Peripheral Blood Cells and/or Body Fluids in People Living With and Without HIV
NCT00001281
RECRUITING
Endothelial Function, Lipoproteins, and Inflammation With Low HDL Cholesterol in HIV: ER Niacin Versus Fenofibrate
NCT01426438
COMPLETED
PHASE2
Suppression of HIV 1 RNA in People Living With HIV
NCT02363387
COMPLETED
NA
Blood Vessel Function in HIV-Infected Patients Taking Anti-HIV Drugs
NCT00050908
COMPLETED
A Study of the Long-Term Outcomes of HIV-Positive Patients
NCT00000932
COMPLETED
Examining the Link Between Heart Disease and HIV Infection in Women
NCT00312468
COMPLETED
Cardiovascular Prevention for Persons With HIV
NCT00982189
COMPLETED
NA
The Effects of Anti-HIV Drugs on the HIV Virus in HIV-Infected Patients
NCT00006442
COMPLETED
Effectiveness Study Low-Dose Naltrexone Versus ARV's for HIV+
NCT01174914
COMPLETED
PHASE2
Subclinical Atherosclerosis in HIV-infected Patients
NCT00455793
COMPLETED
The Safety and Effectiveness of Retrovir in HIV-Infected Patients Who Have Problems Related to the Nervous System
NCT00002288
COMPLETED
NA
Zinc Therapy in HIV Infected Individuals Who Abuse Drugs
NCT00149552
COMPLETED
NA
A Clinical Trial for People HIV+ Age > 50 at Risk for Heart Disease
NCT01578772
COMPLETED
PHASE2
Evaluating the Effectiveness of Pentoxifylline at Improving Blood Vessel Function in HIV-infected People Not Receiving Antiretroviral Medications
NCT00796822
COMPLETED
PHASE2
Pentoxifylline and Combination Antiretroviral Therapy to Improve Blood Vessel Function in HIV-Infected People
NCT00864916
COMPLETED
PHASE2