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

NCT04495348 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2023-06-22

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Doravirine

Participants will be switched to doravirine and then switched back to INSTI-based therapy to determine the impact on energy balance.

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Kristine Erlandson, MD · University of Colorado Denver, Anschutz Medical Campus

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-22
Primary Completion
2023-01-25
Completion
2023-06-05

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04495348 on ClinicalTrials.gov