Clinical trial NCT02309372: Depression Therapy to Improve Cardiovascular Risk in HIV
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
HIV
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2014-12-05
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 computerized depression treatment with the other half receiving usual care from their HIV providers.

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 screened to identify 110 participants to be enrolled and randomized. These participants will be ≥ 18 years old, have been receiving antiretroviral therapy for at least one year with an HIV viral load \< 75 copies/mL at screening, and have major depression using the PHQ-9 questionnaire. These participants will be randomized 1:1 to either depression treatment with the Beating-the-Blues cognitive behavioral therapy program (N=55) or usual care (N=55).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Brachial Artery Flow-mediated Dilation From Baseline to Week 12
timeFrame: Baseline and Week 12 of participation
Secondary outcomes:
measure: Changes in Circulating IL-6 From Baseline to Week 12
timeFrame: Baseline and 12 weeks
measure: Change in hsCRP From Baseline to Week 12
timeFrame: 12 weeks
measure: Change in D-dimer From Baseline to Week 12
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health University Hospital, Indiana Clinical Research Center
state: Indiana
city: Indianapolis
country: United States
facility: Infectious Diseases Research Center
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Samir K Gupta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University School of Medicine
name: Jesse C Stewart, PhD
role: PRINCIPAL_INVESTIGATOR
References: