NCT04495348

Explorations Into the Mechanism for INSTI-associated Weight Gain: a Focus on Energy Balance

Completed Last updated 22 June 2023

What this trial tests

trial testing Doravirine in HIV-1-infection in 18 participants. Completed in 5 June 2023.

Timeline

22 October 2020

Primary endpoint
25 January 2023

5 June 2023

Quick facts

Lead sponsor	University of Colorado, Denver
Status	Completed
Study type	OBSERVATIONAL
Enrollment	18
Start date	22 October 2020
Primary completion	25 January 2023
Estimated completion	5 June 2023
Sites	2 locations across United States

Drugs / interventions tested

• Doravirine (DORAVIRINE) — full drug profile →

Conditions studied

• HIV-1-infection — all drugs for HIV-1-infection →
• Weight Gain — all drugs for Weight Gain →

Sponsor

University of Colorado, Denver

Who can join

18 and older, any sex, with HIV-1-infection or Weight Gain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Weight gain following antiretroviral therapy (ART) initiation occurs with all modern regimens. Recent real-world reports suggest that integrase strand transfer inhibitor (INSTI)-based ART may be associated with excess weight gain compared to other regimens. Weight gain appears to occur regardless of baseline weight, and is most pronounced among women and minorities, often those at highest risk of obesity-associated comorbidities. INSTI- and TAF-based regimens are now preferred regimens for most persons according to the Department of Health and Human Services ART-Treatment Guidelines. As a result, there is an urgent need to understand the underlying mechanisms for this weight gain.

This study aims to understand the changes in energy balance that occur with changes in ART. Participants with HIV who have experienced \>10% weight gain on INSTI (bictegravir or dolutegravir-based therapy) will be switched to doravirine for 12 weeks, and then back to their prior INSTI regimen, allowing for assessment of changes in metabolic parameters with drug withdrawal and reintroduction (with no change to NRTI-backbone). Twenty-four hour energy balance will be measured on both regimens during a 24-hour stay using a whole room indirect calorimetry, with a standardized diet. Ultimately, the investigator's goal is to understand the mechanisms of weight gain so that future interventions can most effectively mitigate ART-associated weight changes.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Energy balance and body composition after switch between integrase strand transfer inhibitors and doravirine among people with HIV.
   Erlandson KM, Mohaweche R, Morrow M, Mawhinney S, et al · · 2024 · cited 2× · PMID 38000089 · DOI 10.1093/jac/dkad363