Explorations into the mechanism for INSTI-associated weight gain: a focus on energy balance

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Inclusion: - Adults age >=18 years - BMI of >=30.0 kg/m2 - >=10% weight gain within the first 2 years of switching to INSTI-based ART (bictegravir or dolutegravir-based regimens only), with weight gain that has continued or worsened (not decreased). - At least one plasma HIV-1 RNA <50 copies/mL while on the current INSTI-based ART within 6 months of screening - Willing to switch to doravirine and pay any associated co-pays that may not be covered by insurance. - 2 NRTI back-bone therapy with either TAF or TDF with 3TC or FTC and willing to continue these 2 agents. Exclusion - Use of an INSTI other than bictegravir or dolutegravir within the 1 year prior to entry - Any plasma HIV-1 RNA >500 copies/mL within one year prior to entry - Pregnant, breast-feeding, or intention to become pregnant during the study period

Type of Study

Outcomes Research


Compensation provided

Principal Investigator
Photograph of Kristine Erlandson,  MD

Kristine Erlandson, MD

Study ID

Protocol Number: 19-2960

More information available at ClinicalTrials.gov: NCT04495348

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