Doravirine and Weight Gain in Antiretroviral Naive (DAWN)

Effect of Modified, Rapid-start, DOR/3TC/TDF or DOR + FTC/TAF or BIC/FTC/TAF on Body Weight and Composition, Metabolic Risk Parameters, and Measures of Bone Strength in Treatment-Naïve Black and Hispanic Women With HIV-1 Infection

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 Overview

• Status: Withdrawn
• Conditions: Obesity; Metabolic Syndrome; Body Weight Changes; Human Immunodeficiency Virus; Fasting; Minority Health; ART; BMD
• Intervention / Treatment: Drug: DOR/3TC/TDF; Combination product: DOR + FTC/TAF; Drug: BIC/FTC/TAF

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.

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• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Dindi Matthews; Phone Number: 9728077380; Email: dindi.matthews@prismntx.org
• Study Contact Backup: Name: Carla Romo-Sikes; Phone Number: 9728077380; Email: carla.romo-sikes@prismntx.org

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75208
      • Prism Health North Texas
      • Contact: Carla Romo-Sikes; Phone Number: 9728077380; Email: carla.romo-sikes@prismntx.org
      • Contact: Dindi Matthews; Phone Number: 337-255-7802; Email: dindi.matthews@prismntx.org
      • Principal Investigator: Roger Bedimo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate; Participants to receive DOR/3TC/TDF tablet once daily for 48 weeks	Drug: DOR/3TC/TDF; 100 mg of doravirine (DOR), 300 mg of lamivudine (3TC), and 300 mg of TDF; Other Names: Delstrigo
Active Comparator: Doravirine + Emtricitibine/Tenofovir alafenamide Fumerate; Participants to receive DOR + FTC/TAF tablets once daily for 48 weeks	Combination product: DOR + FTC/TAF; 100 mg of doravirine + 200 mg emtricitabine (FTC) and 25 mg of tenofovir alefenamide fumerate (TAF); Other Names: Pifeltro + Descovy
Active Comparator: Bictegravir/Emtricitibine/Tenofovir alafenamide; Participants to receive BIC/FTC/TAF tablet once daily for 48 weeks	Drug: BIC/FTC/TAF; Bictegravir sodium 50 mg, emtricitabine 200mg, tenofovir alefenamide fumerate 25mg; Other Names: Biktarvy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Prism Health North Texas
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Roger Bedimo, Prism Health North Texas

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): May 3, 2023
• Study Completion (Actual): May 3, 2023

Study Registration Dates

• First Submitted: April 15, 2022
• First Submitted That Met QC Criteria: July 12, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Hispanic Women; Treatment Naive; 18 years or older; African American Women; Fasting Glucose; Fasting Insuline; Negative pregnancy test
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Insulin Resistance; Hyperinsulinism; Slow Virus Diseases; HIV Infections; Metabolic Syndrome; Body Weight; Acquired Immunodeficiency Syndrome; Body Weight Changes; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Emtricitabine tenofovir alafenamide
• Other Study ID Numbers: 60160

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes