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This study examines the effect on adipose (fat) tissue of switching HIV-positive people's treatment to the combination TDF/3TC/Doravirine. It enrolled HIV-positive patients over 18 whose virus was suppressed and who had gained weight while on an INSTI-based regimen. It was a study without a phase and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * HIV positive patient \> 18 years * HIV RNA \< 50 copies/ml in the last 6 months * on INSTI based regimen (dual or 3-DR) since at least 6 months * Creatinine clearance \> 60 ml/min * With a body weight increase defined as: * 10% from pre INSTI body weight whatever duration of INSTI duration OR * 5% during the first year after INSTI regimen initiation Exclusion Criteria: * Prior hypersensitivity to NNRTI * Resistance to doravirine in past resistance genotype(s) if available * Full resistance to tenofovir in past resistance genotype(s) if available * Diabetes, type 1 or type 2 assessed on by fasting glycemia over 7mmol/L, or non-fasting glycemia over 11 mmol/L or receiving anti-diabetic medications. * Pregnancy and breast feeding * Prior bariatric surgery * Hemostasis disorder or hemophilia * Oral or injectable anti-diabetics, thyroid hormones, growth hormone, insulin, and corticosteroid therapy lasting more than 5 days. * Body weight increase (in a context of recent tobacco cessation, introduction of psychotropic drugs, corticosteroids for at least one month, dysthyroidism, anabolic treatment or any hormonal therapy 6 months) * Current antineoplastic chemotherapy * Patient with instable housing * Any acute infection or tumor * Subjects under judicial protection due to temporarily and slightly diminished mental or physical faculties, or under legal guardianship