NCT03299205: ALIVE-Ex

Alcohol & Metabolic Comorbidities in PLWHA: Evidence Driven Interventions

Completed NA Last updated 3 October 2023

What this trial tests

NA trial testing Exercise in HIV/AIDS in 68 participants. Completed in 15 September 2023.

Timeline

20 November 2017

Primary endpoint
15 September 2023

15 September 2023

Quick facts

Lead sponsor	Louisiana State University Health Sciences Center in New Orleans
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	68
Start date	20 November 2017
Primary completion	15 September 2023
Estimated completion	15 September 2023
Sites	1 location across United States

Drugs / interventions tested

• Exercise

Conditions studied

• HIV/AIDS — all drugs for HIV/AIDS →
• Dysglycemia — all drugs for Dysglycemia →
• Alcohol Use Disorder — all drugs for Alcohol Use Disorder →

Sponsor

Louisiana State University Health Sciences Center in New Orleans

Who can join

18 and older, any sex, with HIV/AIDS or Dysglycemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cross-sectional and prospective studies are proposed to test the prediction that a higher proportion of HIV+ individuals with hazardous alcohol drinking with subclinical fasting dysglycemia will present with impaired oral glucose tolerance and dysfunctional metabolic skeletal muscle phenotype. Prospective studies will test the efficacy of an exercise intervention in improving glycemic control. Results will inform larger scale interventions to ameliorate metabolic comorbidities, improve health, quality of life, and possibly decrease hazardous alcohol drinking.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Skeletal muscle bioenergetic health and function in people living with HIV: association with glucose tolerance and alcohol use.
   Levitt DE, Ferguson TF, Primeaux SD, Zavala JA, et al · · 2021 · cited 17× · PMID 34585616 · DOI 10.1152/ajpregu.00197.2021
2. Alcohol use and dysglycemia among people living with human immunodeficiency virus (HIV) in the Alcohol & Metabolic Comorbidities in PLWH: Evidence Driven Interventions (ALIVE-Ex) study.
   Primeaux SD, Simon L, Ferguson TF, Levitt DE, et al · · 2021 · cited 9× · PMID 34342022 · DOI 10.1111/acer.14667
3. Unique circulating microRNA associations with dysglycemia in people living with HIV and alcohol use.
   Bourgeois BL, Lin HY, Yeh AY, Levitt DE, et al · · 2022 · cited 5× · PMID 34859690 · DOI 10.1152/physiolgenomics.00085.2021
4. An aerobic exercise intervention to improve metabolic health among people living with HIV with at-risk alcohol use: the ALIVE-Ex research study protocol.
   Simon L, Primeaux SD, Levitt DE, Bourgeois B, et al · · 2023 · cited 2× · PMID 37296413 · DOI 10.1186/s12981-023-00530-2
5. Alcohol misuse and health-related behaviors among people with HIV during the COVID-19 stay-at-home directive: an ALIVE-Ex sub-study.
   Ferguson TF, Levitt DE, Simon L, Molina PE, et al · · 2025 · PMID 40267314 · DOI 10.1093/alcalc/agaf019