Stimulant Use and Methylation in HIV

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05916989

Enrollment

Registered

2023-06-23

Start date

2018-09-30

Completion date

2022-10-26

Last updated

2023-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Methamphetamine Abuse, Methamphetamine-dependence

Keywords

HIV, Methamphetamine, Methylation

Brief 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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Neuroimmune Signaling	6 Months	Decreased methylation of genes for genes relevant to neuroimmune signaling such as beta-2 (β2) 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.

Secondary

Measure	Time frame	Description
DNA Methylation Pathways	6 Months	Pathway Analyses examining alterations in methylation patterns relevant to immune and neural function.
Immune Dysfunction	6 Month	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)
Dysregulated Metabolism of Amino Acid Precursors for Neurotransmitters measured via high-performance liquid chromatography (HPLC)	6 Months	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.

Countries

United States

Outcome results