Doravirine and Weight Gain in Antiretroviral Naive

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is determine whether different antiretroviral therapy (ART) changes the effects on body fat and predict the weight change in Black and Hispanic females.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Prism Health North Texas
• Collaborator: Merck Sharp & Dohme LLC
• Treatments: Emtricitabine tenofovir alafenamide

Criteria

Inclusion Criteria:

• 18 years or older;

• No prior exposure to antiretroviral therapy for >7 days prior to study entry;

• Plasma HIV1 RNA concentration >/=5000 copies/mL;

• CD4 T cell count >/=200 cells/µL.

• For persons capable of becoming pregnant, negative serum or urine pregnancy test within 45 days prior to entry

• Ability and willingness of participant or legal guardian/representative to provide informed consent

Exclusion Criteria:

• Evidence of resistance to DOR, TDF, 3TC/FTC or BIC.

• Creatinine clearance <60 mL/min

• Use of weight loss agents or plans to initiate weight loss program (diet or exercise-based)

• Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation