Depression Therapy to Improve Cardiovascular Risk in HIV

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02309372
• Date of registration: 03/12/2014
• Prospective Registration: Yes
• Primary sponsor: Indiana University
• Public title: Depression Therapy to Improve Cardiovascular Risk in HIV
• Scientific 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
• Date of first enrolment: April 2015
• Target sample size: 54
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02309372
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Samir K Gupta, MD
• Affiliation: Indiana University School of Medicine

• Name: Jesse C Stewart, PhD
• Affiliation: Indiana University School of Medicine

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Depression

HIV

Intervention(s)

Behavioral: Beating the Blues

Primary Outcome(s)

Change in Brachial Artery Flow-mediated Dilation From Baseline to Week 12 [Time Frame: Baseline and Week 12 of participation]

Secondary Outcome(s)

Change in D-dimer From Baseline to Week 12 [Time Frame: 12 weeks]

Change in hsCRP From Baseline to Week 12 [Time Frame: 12 weeks]

Changes in Circulating IL-6 From Baseline to Week 12 [Time Frame: Baseline and 12 weeks]

Secondary ID(s)

R01HL126557

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 14/07/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02309372