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

Study category: Immune System and Allergy

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Details
Age

Adult

Eligibility

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

Locations

Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Kristine Erlandson,  MD

Kristine Erlandson, MD

Study ID

Protocol Number: 19-2960

More information available at ClinicalTrials.gov: NCT04495348

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