N/A N=54 Randomized Single-blind Treatment

Depression Therapy to Improve Cardiovascular Risk in HIV

Depression · HIV

Bottom Line

View on ClinicalTrials.gov: NCT02309372 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2020

Primary outcome: Primary: Change in Brachial Artery Flow-mediated Dilation From Baseline to Week 12 — -0.47; 0.29 absolute percent change — p=0.32

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Beating the Blues (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Indiana University
Primary completion: Apr 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Brachial Artery Flow-mediated Dilation From Baseline to Week 12	-0.47; 0.29	0.32
SECONDARY Changes in Circulating IL-6 From Baseline to Week 12	2.38; 1.24	—
SECONDARY Change in hsCRP From Baseline to Week 12	1.22; 1.06	—
SECONDARY Change in D-dimer From Baseline to Week 12	3.69; -10.26	—

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.

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 160 mmHg or diastolic blood pressure > 110 mmHg at screening
Screening estimated glomerular filtration rate (eGFR) 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02309372). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.