Clinical trial NCT04721067: HIV-related Insomnia and Inflammation
Official title: Treating Insomnia to Reduce Inflammation in HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Insomnia
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-01-22
Enrollment: 30
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 randomized trial will determine the effects of internet cognitive behavioral therapy on measures of systemic inflammation in HIV-positive people receiving antiretroviral therapy.

Detailed description: The primary objective of this pilot trial is to evaluate the effects of cognitive behavioral therapy for insomnia (CBT-I) on changes in circulating levels of hsCRP at 24 weeks in virologically-suppressed, HIV-positive adults with insomnia, defined as having an Insomnia Severity Index (ISI) score ≥ 11. Secondary objectives include comparing changes in hsCRP at 12 weeks, changes in other circulating inflammation biomarkers (IL-6, sCD14, sCD163, CD14+CD16+ monocytes) at both 12 and 24 weeks, and ISI scores and other self-reported patient outcomes at both 12 and 24 weeks.

Eligibility criteria: Inclusion Criteria:

* HIV-1 infection, documented as listed clinically in the participant's electronic medical record by any of the following tests: (1) any licensed rapid HIV test, (2) HIV enzyme test kit at any time prior to study entry, (3) at least one detectable HIV-1 antigen, or (4) at least one detectable plasma HIV-1 RNA viral load.
* Age equal to or greater than 18 years.
* Ongoing receipt of stable antiretroviral therapy of any kind for at least 180 days prior to the date of the HIV-1 RNA value determining eligibility.
* HIV-1 RNA level \< 75 copies/mL at Screening.

NOTE: There are no CD4 cell count eligibility criteria for this trial.

-ISI score ≥ 11 at Screening.

NOTE: Use of sleeping aids/medications is permitted as long as the ISI score criterion is met.

Exclusion Criteria:

* Inability to complete written, informed consent.
* Incarceration at the time of any study visit.
* Active suicidality at Entry, 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 (for Question #3, the previous attempt must be within the past 10 years) on the Patient Suicidality Form (see Appendix).
* Diagnosed disease or process, besides HIV infection, associated with increased systemic inflammation (including, but not limited to, systemic lupus erythematosus, inflammatory bowel diseases, or other collagen vascular diseases).

NOTE: Hepatitis B or C co-infections are NOT exclusionary, but treatment for hepatitis C cannot be provided during study participation.

* End stage renal disease requiring renal replacement therapy (dialysis, transplantation).
* Known or suspected malignancy requiring systemic treatment within 180 days of the Entry Visit.

NOTE: Localized treatment for skin cancers is not exclusionary.

-Therapy for serious medical illnesses within 14 days prior to the Entry Visit.

NOTE: Therapy for serious medical illnesses that overlaps with a 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 immunosuppressive therapies, systemic glucocorticoids (of any dose), or anabolic steroids at the Entry Visit.

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 bipolar disorder or a psychotic disorder, including schizophrenia.

NOTE: Depressive disorders are not exclusionary.

* Current sleep disorder diagnosis other than insomnia disorder (e.g., sleep apnea).
* Have a schedule requiring a bedtime earlier than 8:00pm or later than 2:00am or arising time earlier than 4:00am or later than 10:00am (thus preventing adoption of SHUTi interventions).

Primary outcomes:
measure: Change in hsCRP Levels at 24 Weeks
timeFrame: Baseline and 24 weeks
Secondary outcomes:
measure: Change in IL-6 Levels at 24 Weeks
timeFrame: Baseline and 24 weeks
measure: Change is sCD14 Levels at 24 Weeks
timeFrame: Baseline and 24 weeks
measure: Change in sCD163 Levels at 24 Weeks
timeFrame: Baseline and 24 weeks
measure: Change in CD14+CD16+ Monocytes at 24 Weeks
timeFrame: Baseline and 24 weeks
measure: Change in hsCRP Levels at 12 Weeks
timeFrame: Baseline and 12 weeks
measure: Change in Insomnia Severity Index (ISI) at 24 Weeks
timeFrame: Baseline and 24 weeks
measure: Change in Pittsburgh Sleep Quality Index (PSQI) at 24 Weeks
timeFrame: Baseline and 24 weeks
measure: Change in Dysfunctional Beliefs and Attitudes About Sleep (DBAS-16) at 24 Weeks
timeFrame: Baseline and 24 weeks
measure: Change in Patient Health Questionnaire-9 (PHQ-9) at 24 Weeks
timeFrame: Baseline and 24 weeks
measure: Change in Hopkins Symptom Checklist (SCL-20) at 24 Weeks
timeFrame: Baseline and 24 weeks
measure: Change in Generalized Anxiety Disorder-7 (GAD-7) at 24 Weeks
timeFrame: Baseline and 24 weeks
measure: Change in PROMIS FACIT-F Fatigue Short Form at 24 Weeks
timeFrame: Baseline and 24 weeks
measure: Change in Alcohol Use Disorders Identification Test (AUDIT) at 24 Weeks
timeFrame: Baseline and 24 weeks
measure: Change in Short Form-36 (SF-36) Health Survey and 24 Weeks
timeFrame: Baseline and 24 weeks
measure: Use of Sleep Medications at Week 12
timeFrame: Week 12
measure: Use of Sleep Medications at Week 24
timeFrame: Week 24
measure: Insomnia Treatment Satisfaction at Week 12
timeFrame: Week 12
measure: Insomnia Treatment Satisfaction at Week 24
timeFrame: Week 24
measure: Change in Pittsburgh Sleep Quality Index (PSQI) at 12 Weeks
timeFrame: Baseline and 12 weeks
measure: Change in Dysfunctional Beliefs and Attitudes About Sleep (DBAS-16) at 12 Weeks
timeFrame: Baseline and 12 weeks
measure: Change in Patient Health Questionnaire-9 (PHQ-9) at 12 Weeks
timeFrame: Baseline and 12 weeks
measure: Change in Hopkins Symptom Checklist (SCL-20) at 12 Weeks
timeFrame: Baseline and 12 weeks
measure: Change in Generalized Anxiety Disorder-7 (GAD-7) at 12 Weeks
timeFrame: Baseline and 12 weeks
measure: Change in PROMIS FACIT-F Fatigue Short Form at 12 Weeks
timeFrame: Baseline and 12 weeks
measure: Change in Alcohol Use Disorders Identification Test (AUDIT) at 12 Weeks
timeFrame: Baseline and 12 weeks
measure: Change in Short Form-36 (SF-36) Health Survey and 12 Weeks
timeFrame: Baseline and 12 weeks
measure: Change in IL-6 Levels at 12 Weeks
timeFrame: Baseline and 12 weeks
measure: Change is sCD14 Levels at 12 Weeks
timeFrame: Baseline and 12 weeks
measure: Change in sCD163 Levels at 12 Weeks
timeFrame: Baseline and 12 weeks
measure: Change in CD14+CD16+ Monocytes at 12 Weeks
timeFrame: Baseline and 12 weeks
measure: Change in Insomnia Severity Index (ISI) at 12 Weeks
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Infectious Diseases Research
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Samir K Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References: