Status:
COMPLETED
Depression Therapy to Improve Cardiovascular Risk in HIV
Lead Sponsor:
Indiana University
Conditions:
Depression
HIV
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This trial will determine if depression treatment will reduce cardiovascular risk in HIV-infected patients already receiving HIV treatments. Half of the participants will undergo a specific computeriz...
Detailed Description
The objectives of this study will be met by performing a 24-week, randomized, controlled, single-blinded, two-arm, parallel group, pilot trial at a single center. A total of 200 subjects may be screen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2019
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT02309372
Start Date
April 1 2015
End Date
April 1 2019
Last Update
July 14 2020
Active Locations (2)
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1
Indiana University Health University Hospital, Indiana Clinical Research Center
Indianapolis, Indiana, United States, 46202
2
Infectious Diseases Research Center
Indianapolis, Indiana, United States, 46202