HIV-related Insomnia and Inflammation

Completed · Not applicable

Conditions studied: Hiv, Insomnia

In brief

This randomized trial will determine the effects of internet cognitive behavioral therapy on measures of systemic inflammation in HIV-positive people receiving antiretroviral therapy.

Key facts

Study ID

NCT04721067

Run by

Indiana University

People needed

30

Starts

2021-12-02

Expected to finish

2024-03-15

Last updated by the study team

2025-05-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Indiana University Infectious Diseases Research — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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