Body Weight Changes, Human Immunodeficiency Virus, ART, Obesity, Minority Health, BMD, Metabolic Syndrome, Fasting
Conditions
Keywords
Treatment Naive, African American Women, Hispanic Women, Fasting Glucose, Fasting Insuline, Negative pregnancy test, 18 years or older
Brief 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.
Detailed description
Study is three-arm, open-label, randomized, interventional trial, in which all patients who are successfully enrolled will be randomized 1:1:1 to initiate ART therapy with Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate vs. Doravirine + Emtricitabine/Tenofovir Alefenamide, Bictegravir/Emtricitabine/Tenofovir Alafenamide. All patients will be followed or a total o 48 weeks. .
Interventions
DRUGDOR/3TC/TDF
100 mg of doravirine (DOR), 300 mg of lamivudine (3TC), and 300 mg of TDF
COMBINATION_PRODUCTDOR + FTC/TAF
100 mg of doravirine + 200 mg emtricitabine (FTC) and 25 mg of tenofovir alefenamide fumerate (TAF)
DRUGBIC/FTC/TAF
Bictegravir sodium 50 mg, emtricitabine 200mg, tenofovir alefenamide fumerate 25mg
Sponsors
Merck Sharp & Dohme LLC
Prism Health North Texas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline of BMI after Initiation of ART Therapy at Week 48 | Week 48 | Comparison of weight and height is collected prior to, and during ART to determine baseline and changes of BMI (kg/m2) on ART. |
| Change of BMI Category after Initiation of ART Therapy at Week 48 | Week 48 | Comparison of participants w/ \>10% weight change in the study arms. BMI categories: underweight (\<18.5) or normal weight (18.5 - 25) or overweight (25 - 30) or obese (\>30); or from overweight to obese. |
| Change in Regional Lean and Body Mass | Week 48 | Whole body Dual-energy X-ray absorptiometry (DEXA) scan (Hologic, QDR 4500A) will measure changes between study arms. |
Countries
United States
Outcome results
None listed