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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate | Active Comparator | Participants to receive DOR/3TC/TDF tablet once daily for 48 weeks |
|
| Doravirine + Emtricitibine/Tenofovir alafenamide Fumerate | Active Comparator | Participants to receive DOR + FTC/TAF tablets once daily for 48 weeks |
|
| Bictegravir/Emtricitibine/Tenofovir alafenamide | Active Comparator | Participants to receive BIC/FTC/TAF tablet once daily for 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DOR/3TC/TDF | Drug | 100 mg of doravirine (DOR), 300 mg of lamivudine (3TC), and 300 mg of TDF |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline of BMI after Initiation of ART Therapy at 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. | Week 48 |
| Change of BMI Category after Initiation of ART Therapy at 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. | Week 48 |
| Change in Regional Lean and Body Mass | Whole body Dual-energy X-ray absorptiometry (DEXA) scan (Hologic, QDR 4500A) will measure changes between study arms. | Week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger Bedimo | Prism Health North Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prism Health North Texas | Dallas | Texas | 75208 | United States |
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| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D000163 | Acquired Immunodeficiency Syndrome |
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| D005215 | Fasting |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015658 | HIV Infections |
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| ID | Term |
|---|---|
| D017465 | Receptors, Opioid, delta |
| C000592662 | doravirine |
| C000613801 | emtricitabine tenofovir alafenamide |
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
| ID | Term |
|---|---|
| D011957 | Receptors, Opioid |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
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| DOR + FTC/TAF | Combination Product | 100 mg of doravirine + 200 mg emtricitabine (FTC) and 25 mg of tenofovir alefenamide fumerate (TAF) |
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| BIC/FTC/TAF | Drug | Bictegravir sodium 50 mg, emtricitabine 200mg, tenofovir alefenamide fumerate 25mg |
|
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| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D018013 | Receptors, Neuropeptide |
| D017981 | Receptors, Neurotransmitter |
| D018000 | Receptors, Peptide |