- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02309372
Depression Therapy to Improve Cardiovascular Risk in HIV
A Randomized, Controlled Pilot Trial Assessing the Utility of Cognitive Behavioral Therapy to Improve Endothelial Function and Reduce Inflammation in Depressed, Virologically-Suppressed, Antiretroviral-Treated, HIV-infected Adults
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202
- Infectious Diseases Research Center
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Indianapolis, Indiana, Forenede Stater, 46202
- Indiana University Health University Hospital, Indiana Clinical Research Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- HIV-1 infection, documented by both: (1) any licensed rapid HIV test or HIV enzyme test kit at any time prior to study entry and (2) by at least one detectable HIV-1 antigen or at least one detectable plasma HIV-1 RNA viral load
- Age equal to or greater than 18 years
- Receipt of antiretroviral therapy of any kind for at least 360 days prior to screening
Note: Interruptions in ART of up to 14 days total during the 360 days prior to screening are allowed
- HIV-1 RNA level < 75 copies/mL at screening
NOTE: There are no CD4 cell count eligibility criteria for this trial
- For women who are still of reproductive potential, a negative urine pregnancy test
- Depression as defined by having a score ≥ 10 on the PHQ-9 questionnaire
Exclusion Criteria:
- Inability to complete written, informed consent
- Incarceration at the time of any study visit
- Active suicidality, as determined by the patient's HIV provider or social worker following a positive response (1, 2, or 3) to PHQ-9 Item #9 and a positive response (yes) to one or more of the three questions on the Patient Suicidality Form (with last suicide attempt within the past ten years)
- Diagnosed vascular disease (documented history of angina pectoris, coronary disease, peripheral vascular disease, cerebrovascular disease, aortic aneurysm, or otherwise known atherosclerotic disease)
- History of congestive heart failure, even if currently compensated
- Diagnosed disease or process, besides HIV infection, associated with increased systemic inflammation (including, but not limited to, systemic lupus erythematosis, inflammatory bowel diseases, other collagen vascular diseases)
Note: Hepatitis B or C co-infections are NOT exclusionary
- Known or suspected malignancy requiring systemic treatment within 180 days of screening
NOTE: Localized treatment for skin cancers is not exclusionary
- History of Raynaud's phenomenon
- History of cardiac arrhythmias or cardiomyopathy
- Uncontrolled hyperthyroidism or hypothyroidism, defined as TSH values outside of the local reference range on most recent clinical assessment
- History of carotid bruits
- Systolic blood pressure > 160 mmHg or diastolic blood pressure > 110 mmHg at screening
- Screening estimated glomerular filtration rate (eGFR) < 50 mL/min/1.732 (using the 2009 CKD-EPI equation) using a serum creatinine level measured at screening
- Screening glucose ≥ 140 mg/dL or hemoglobin A1c > 8.0%
- Screening total cholesterol > 240 mg/dL
- Therapy for serious medical illnesses within 14 days prior to screening
Note: Therapy for serious medical illnesses that overlaps with a main study visit will result in postponement of that study visit until the course of therapy is completed; postponement outside of the allowed study visit timeframe will result in study discontinuation
- Pregnancy or breastfeeding during the course of the study
- Receipt of investigational agents, cytotoxic chemotherapy, systemic glucocorticoids (of any dose), or anabolic steroids at screening
Note: Physiologic testosterone replacement therapy or topical steroids is not exclusionary. Inhaled/nasal steroids are not exclusionary as long as the participant is not also receiving HIV protease inhibitors
- Active drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
- History of schizophrenia or bipolar disorder
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Cognitive Behavioral Therapy (CBT)
Those assigned to the CBT arm will undergo therapy with the Beating the Blues (BtB) computerized intervention.
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Computerized depression treatment intervention
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Ingen indgriben: Usual Care
No specific depression care will be provided through this study for those assigned to this arm.
However, the participant's caregiver may choose to provide depression treatment outside of this trial.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in Brachial Artery Flow-mediated Dilation From Baseline to Week 12
Tidsramme: Baseline and Week 12 of participation
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Changes in flow-mediated dilation of the brachial artery from baseline to week 12.
This is calculated by the FMD value at Week 12 minus the FMD value at baseline.
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Baseline and Week 12 of participation
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Changes in Circulating IL-6 From Baseline to Week 12
Tidsramme: Baseline and 12 weeks
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Interleukin-6 (IL-6) is a measure of systemic inflammation.
This is calculated by the IL-6 value at Week 12 minus the IL-6 value at baseline.
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Baseline and 12 weeks
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Change in hsCRP From Baseline to Week 12
Tidsramme: 12 weeks
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hsCRP (high sensitivity C-reactive protein) is a measure of systemic inflammation.
This is calculated by the hsCRP value at Week 12 minus the hsCRP value at baseline.
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12 weeks
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Change in D-dimer From Baseline to Week 12
Tidsramme: 12 weeks
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D-dimer is a measure of systemic coagulation.
This is calculated by the D-dimer value at Week 12 minus the D-dimer value at baseline.
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12 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Samir K Gupta, MD, Indiana University School of Medicine
- Ledende efterforsker: Jesse C Stewart, PhD, Indiana University School of Medicine
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R01HL126557 (U.S. NIH-bevilling/kontrakt)
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