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HIV-related Insomnia and Inflammation | Clinical Trials | Clareo Health

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HIV-related Insomnia and Inflammation

Treating Insomnia to Reduce Inflammation in HIV

NCT04721067•Indiana University

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+8 more criteria

Locations (1)

Indiana University Infectious Diseases Research

Indianapolis, Indiana, United States

Key Dates

Start Date

December 2, 2021

Primary Completion Date

March 15, 2024

Completion Date

March 15, 2024

Last Updated

May 29, 2025

Enrollment

ACTUAL participants

Conditions

HivInsomnia

Interventions

SHUTi

DEVICE

Sleep Education/Hygiene

BEHAVIORAL

Thinking and Memory Problems in People With HIV

NCT01875588

HIV Positive

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RECRUITINGPHASE2

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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HIV-related Insomnia and Inflammation

Inclusion Criteria

Exclusion Criteria

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