Body Weight ChangesPhase 3DAWNNCT05457530
Doravirine and Weight Gain in Antiretroviral Naive
A Phase 3 study testing DOR/3TC/TDF, DOR + FTC/TAF and BIC/FTC/TAF in people with Body Weight Changes and Human Immunodeficiency Virus, run by Prism Health North Texas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Weight Changes, Human Immunodeficiency Virus, ART
- What is being tested?
- DOR/3TC/TDF, DOR + FTC/TAF and BIC/FTC/TAF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 3 May 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
.
- Conditions
- Body Weight Changes, Human Immunodeficiency Virus, ART, Obesity, Minority Health, BMD
- Being tested
- DOR/3TC/TDF, DOR + FTC/TAF, BIC/FTC/TAF
- Keywords
- Treatment Naive, African American Women, Hispanic Women, Fasting Glucose, Fasting Insuline, Negative pregnancy test, 18 years or older
- Medical subject headings
- Body Weight Changes, Acquired Immunodeficiency Syndrome, Obesity, Metabolic Syndrome, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOR/3TC/TDFDrug
Also called Delstrigo
100 mg of doravirine (DOR), 300 mg of lamivudine (3TC), and 300 mg of TDF
DOR + FTC/TAFCombination product
Also called Pifeltro + Descovy
100 mg of doravirine + 200 mg emtricitabine (FTC) and 25 mg of tenofovir alefenamide fumerate (TAF)
BIC/FTC/TAFDrug
Also called Biktarvy
Bictegravir sodium 50 mg, emtricitabine 200mg, tenofovir alefenamide fumerate 25mg
| Study group | Role | What they receive |
|---|---|---|
| Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate | Active comparator | Participants to receive DOR/3TC/TDF tablet once daily for 48 weeks Receives: Drug: DOR/3TC/TDF |
| Doravirine + Emtricitibine/Tenofovir alafenamide Fumerate | Active comparator | Participants to receive DOR + FTC/TAF tablets once daily for 48 weeks Receives: Combination Product: DOR + FTC/TAF |
| Bictegravir/Emtricitibine/Tenofovir alafenamide | Active comparator | Participants to receive BIC/FTC/TAF tablet once daily for 48 weeks Receives: Drug: BIC/FTC/TAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start1 Aug 2022
- Primary completion3 May 2023
- Study completion3 May 2023
Why it stopped: Due to No/Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Weight ChangesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prism Health North Texas
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Roger Bedimo, Principal investigator, Prism Health North Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457530
- Sponsor's protocol ID
- 60160
- Acronym
- DAWN
- Status last verified
- May 2023
- First submitted
- 15 Apr 2022
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05457530
- Acronym / sponsor ID
- DAWN / 60160
- Conditions
- Body Weight Changes, Human Immunodeficiency Virus, ART, Obesity, Minority Health, BMD
- Keywords
- Treatment Naive, African American Women, Hispanic Women, Fasting Glucose, Fasting Insuline, Negative pregnancy test, 18 years or older
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to No/Low enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Prism Health North TexasUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 3 May 2023 (actual)
- Study completion
- 3 May 2023 (actual)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate | Active comparator | Drug: DOR/3TC/TDFParticipants to receive DOR/3TC/TDF tablet once daily for 48 weeks |
| Doravirine + Emtricitibine/Tenofovir alafenamide Fumerate | Active comparator | Combination Product: DOR + FTC/TAFParticipants to receive DOR + FTC/TAF tablets once daily for 48 weeks |
| Bictegravir/Emtricitibine/Tenofovir alafenamide | Active comparator | Drug: BIC/FTC/TAFParticipants to receive BIC/FTC/TAF tablet once daily for 48 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DOR/3TC/TDFAlso: Delstrigo100 mg of doravirine (DOR), 300 mg of lamivudine (3TC), and 300 mg of TDF | Drug | Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate |
| DOR + FTC/TAFAlso: Pifeltro + Descovy100 mg of doravirine + 200 mg emtricitabine (FTC) and 25 mg of tenofovir alefenamide fumerate (TAF) | Combination product | Doravirine + Emtricitibine/Tenofovir alafenamide Fumerate |
| BIC/FTC/TAFAlso: BiktarvyBictegravir sodium 50 mg, emtricitabine 200mg, tenofovir alefenamide fumerate 25mg | Drug | Bictegravir/Emtricitibine/Tenofovir alafenamide |
Primary outcome
Change from Baseline of BMI after Initiation of ART Therapy at Week 48
Time frame: 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
Time frame: 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
Time frame: Week 48
Whole body Dual-energy X-ray absorptiometry (DEXA) scan (Hologic, QDR 4500A) will measure changes between study arms.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Bedimo principal investigator
Prism Health North Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DOR/3TC/TDF, DOR + FTC/TAF and BIC/FTC/TAF in people with Body Weight Changes and Human Immunodeficiency Virus, run by Prism Health North Texas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline of BMI after Initiation of ART Therapy at Week 48 (time frame: Week 48). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.