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NCT05916989 Clinical Trial

Stimulant Use and Methylation in HIV

HIV Infections Clinical Trial

Official title:
Stimulant Use and Methylation in HIV

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05916989
Other study ID # 20180865
Secondary ID R01DA033854
Status Completed
Phase
First received
Last updated
Start date September 30, 2018
Est. completion date October 26, 2022

Study information
Verified date November 2023
Source Florida International University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will leverage extracted leukocyte DNA specimens from a completed NIH-funded project to examine the efficacy of a behavioral intervention model that reduced stimulant use on DNA methylation over 6 months.

Recruitment information / eligibility
Status Completed
Enrollment 53
Est. completion date October 26, 2022
Est. primary completion date October 26, 2022
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - At least 18 years old - Documentation of HIV-positive serostatus - Speak English - Biological verification of recent methamphetamine use - Completion of at least three contingency management (CM) visits - Self reported anal sex with a man in the past 12 months Exclusion Criteria: - Inability to provide informed consent, evidenced by cognitive impairment - HIV negative serostatus

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Florida International University Miami Florida

Sponsors (5)
Lead Sponsor Collaborator
Florida International University National Institute on Drug Abuse (NIDA), New York University, Northwestern University, University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Neuroimmune Signaling Decreased methylation of genes for genes relevant to neuroimmune signaling such as beta-2 (ß2) adrenergic (i.e., ADRB2), glucocorticoid (i.e., NR3C1 and FKBP5), and oxytocin (i.e., OXTR) receptors as well as brain-derived neurotrophic factor (BDNF) promoters. 6 Months
Secondary DNA Methylation Pathways Pathway Analyses examining alterations in methylation patterns relevant to immune and neural function. 6 Months
Secondary Immune Dysfunction Soluble makers of monocyte activation such as soluble CD14 (sCD14) and inflammation such as soluble Tumor Necrosis Factor - Alpha Receptors I and II (sTNF-aRI and sTNF-aRII) 6 Month
Secondary Dysregulated Metabolism of Amino Acid Precursors for Neurotransmitters measured via high-performance liquid chromatography (HPLC) Using HPLC, higher kynurenine/tryptophan (K/T) ratio indexes catabolism of tryptophan into kynurenine and other downstream catabolites versus serotonin over 6 months. Using HPLC, the phenylalanine/tyrosine ratio reflects decreased metabolism of tyrosine into catecholamines such as dopamine over 6 months. 6 Months
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