HIV-1, Insufficient Sleep and Vascular Endothelial Dysfunction

HIV-1 Clinical Trial

Official title:

HIV-1, Insufficient Sleep and Vascular Endothelial Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04956861
• Other study ID #: 150465
• Status: Completed
• Phase: N/A
• Start date: December 17, 2015
• Est. completion date: August 7, 2020

Study information

• Verified date: June 2021
• Source: University of Colorado, Boulder
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesize that chronic insufficient sleep is associated with diminished endothelium-dependent nitric oxide-mediated vasodilation and tissue-type plasminogen activator release in anti-retroviral (ART)-treated HIV-1-seropositive adults. Furthermore, the investigators hypothesize that the postulated diminishment in endothelial vasodilator and fibrinolytic function with insufficient sleep will be due, at least in part, to increased oxidative stress. Moreover, increasing sleep duration and improving sleep quality will increase both endothelium-dependent nitric oxide-mediated vasodilation and endothelial tissue-type plasminogen activator release in ART-treated HIV-1-seropositive adults. Increases in endothelial vasodilator and fibrinolytic function will be due, at least in part, to reduced oxidative stress.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: August 7, 2020
• Est. primary completion date: August 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subjects will be men and women of all races and ethnic backgrounds aged 40-75 years with documented HIV-1 infection.

• Subjects will be HIV-1-seropositive individuals on a stable DHHS approved ART regimen for at least 6 months, with documented virologic suppression (<50 copies HIV-1 RNA/mL) for at least 3 months.

• All subjects must have CD4+ T cell counts >200 cells/mm3 at the time of study entry.

• Subjects will be free of overt CVD as assessed by: a) medical history; b) physical examination; c) electrocardiogram and BP at rest and maximal exercise; d) complete blood chemistries, lipid and lipoprotein, glucose, insulin and hematological evaluation.

• All candidates will be sedentary as determined from the Stanford Physical Activity Questionnaire (<35 kcal/wk) and will not have engaged in any program of regular physical activity for at least 6 months prior to the study.

Exclusion Criteria:

• Receiving hormone replacement therapy (HRT) currently or in the preceeding 3-year period.

• Pre- or peri-menopausal women

Related Conditions & MeSH terms

• HIV-1

Intervention

Behavioral:
• Individualized Targeted Sleep
The investigators will employ an 8-week individualized targeted sleep intervention. Individualized targeted interventions have the advantage of improving adherence, reducing attrition, and making the strategy personally meaningful.

Locations

Country	Name	City	State
United States	UC-Boulder Clinical and Translational Research Center	Boulder	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Boulder

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1: Forearm blood flow (FBF) response to Acetylcholine (ACh)		FBF response to ACh will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
Primary	Phase 2: FBF response to Acetylcholine (ACh)	FBF to ACh will me measured following the participants 8 week sleep intervention	FBF response to ACh will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date
Primary	Phase 1: Forearm blood flow (FBF) response to Sodium Nitroprusside (NTP)		FBF response to NTP will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
Primary	Phase 2: Forearm blood flow (FBF) response to Sodium Nitroprusside (NTP)	FBF to NTP will me measured following the participants 8 week sleep intervention	FBF response to NTP will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date
Primary	Phase 1: Endothelial t-PA Release in response to Bradykinin (BDK)		t-PA release will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
Primary	Phase 2: Endothelial t-PA Release in response to Bradykinin (BDK)	Endothelial t-PA release will me measured following the participants 8 week sleep intervention	t-PA release will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date
Primary	Phase 1: FBF response to ACh+L-NMMA		FBF response to ACh+L-NMMA will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
Primary	Phase 1: FBF response to ACh+Vitamin C		FBF response to ACh+Vitamin C will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
Primary	Phase 2: FBF response to ACh+L-NMMA	FBF to ACh+L-NMMA will me measured following the participants 8 week sleep intervention	FBF response to ACh+L-NMMA will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date
Primary	Phase 2: FBF response to ACh+Vitamin C	FBF to ACh+Vitamin C will me measured following the participants 8 week sleep intervention	FBF response to ACh+Vitamin C will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date