Back to resultsDoravirine and Weight Gain in Antiretroviral Naive (DAWN)
Primary Purpose
Body Weight Changes, Human Immunodeficiency Virus, ART
Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
DOR/3TC/TDF
DOR + FTC/TAF
BIC/FTC/TAF
Sponsored by
About this trial
This is an interventional treatment trial for Body Weight Changes focused on measuring Treatment Naive, African American Women, Hispanic Women, Fasting Glucose, Fasting Insuline, Negative pregnancy test, 18 years or older
Eligibility 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
Sites / Locations
- Prism Health North Texas
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate
Doravirine + Emtricitibine/Tenofovir alafenamide Fumerate
Bictegravir/Emtricitibine/Tenofovir alafenamide
Arm Description
Participants to receive DOR/3TC/TDF tablet once daily for 48 weeks
Participants to receive DOR + FTC/TAF tablets once daily for 48 weeks
Participants to receive BIC/FTC/TAF tablet once daily for 48 weeks
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05457530
First Posted
April 15, 2022
Last Updated
May 10, 2023
Sponsor
Prism Health North Texas
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT05457530
Brief Title
Doravirine and Weight Gain in Antiretroviral Naive
Acronym
DAWN
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Due to No/Low enrollment
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
May 3, 2023 (Actual)
Study Completion Date
May 3, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prism Health North Texas
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight Changes, Human Immunodeficiency Virus, ART, Obesity, Minority Health, BMD, Metabolic Syndrome, Fasting
Keywords
Treatment Naive, African American Women, Hispanic Women, Fasting Glucose, Fasting Insuline, Negative pregnancy test, 18 years or older
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate
Arm Type
Active Comparator
Arm Description
Participants to receive DOR/3TC/TDF tablet once daily for 48 weeks
Arm Title
Doravirine + Emtricitibine/Tenofovir alafenamide Fumerate
Arm Type
Active Comparator
Arm Description
Participants to receive DOR + FTC/TAF tablets once daily for 48 weeks
Arm Title
Bictegravir/Emtricitibine/Tenofovir alafenamide
Arm Type
Active Comparator
Arm Description
Participants to receive BIC/FTC/TAF tablet once daily for 48 weeks
Intervention Type
Drug
Intervention Name(s)
DOR/3TC/TDF
Other Intervention Name(s)
Delstrigo
Intervention Description
100 mg of doravirine (DOR), 300 mg of lamivudine (3TC), and 300 mg of TDF
Intervention Type
Combination Product
Intervention Name(s)
DOR + FTC/TAF
Other Intervention Name(s)
Pifeltro + Descovy
Intervention Description
100 mg of doravirine + 200 mg emtricitabine (FTC) and 25 mg of tenofovir alefenamide fumerate (TAF)
Intervention Type
Drug
Intervention Name(s)
BIC/FTC/TAF
Other Intervention Name(s)
Biktarvy
Intervention Description
Bictegravir sodium 50 mg, emtricitabine 200mg, tenofovir alefenamide fumerate 25mg
Primary Outcome Measure Information:
Title
Change from Baseline of BMI after Initiation of ART Therapy at Week 48
Description
Comparison of weight and height is collected prior to, and during ART to determine baseline and changes of BMI (kg/m2) on ART.
Time Frame
Week 48
Title
Change of BMI Category after Initiation of ART Therapy at Week 48
Description
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.
Time Frame
Week 48
Title
Change in Regional Lean and Body Mass
Description
Whole body Dual-energy X-ray absorptiometry (DEXA) scan (Hologic, QDR 4500A) will measure changes between study arms.
Time Frame
Week 48
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Bedimo
Organizational Affiliation
Prism Health North Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prism Health North Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Doravirine and Weight Gain in Antiretroviral Naive
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