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Doravirine + Emtricitibine/Tenofovir alafenamide Fumerate for HIV/AIDS (DAWN Trial)

Phase 3

Waitlist Available

Led By Roger Bedimo

Research Sponsored by Prism Health North Texas

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 48

Awards & highlights

DAWN Trial Summary

This trial will study the effects of different ART on body fat in black and Hispanic females, in order to predict weight change.

Eligible Conditions

HIV/AIDS
Assisted Reproductive Technology
Metabolic Syndrome
Minority Health
Bone Mineral Density
Fasting
Weight Changes
Obesity

DAWN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline of BMI after Initiation of ART Therapy at Week 48

Change in Regional Lean and Body Mass

Change of BMI Category after Initiation of ART Therapy at Week 48

DAWN Trial Design

3Treatment groups

Active Control

Group I: Doravirine + Emtricitibine/Tenofovir alafenamide FumerateActive Control1 Intervention

Participants to receive DOR + FTC/TAF tablets once daily for 48 weeks

Group II: Bictegravir/Emtricitibine/Tenofovir alafenamideActive Control1 Intervention

Participants to receive BIC/FTC/TAF tablet once daily for 48 weeks

Group III: Doravirine/Lamivudine/Tenofovir Disoproxil FumarateActive Control1 Intervention

Participants to receive DOR/3TC/TDF tablet once daily for 48 weeks

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Prism Health North TexasLead Sponsor

1 Previous Clinical Trials

200 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,887 Previous Clinical Trials

5,054,629 Total Patients Enrolled

Roger BedimoPrincipal InvestigatorPrism Health North Texas

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the risks associated with Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate?

"There is some evidence supporting the efficacy of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate, so it has been given a safety rating of 3."

Answered by AI

Is this a fully-enrolled clinical trial or are there still opportunities for individuals to participate?

"The clinical trial in question, which can be found on clinicaltrials.gov, is not currently looking for patients. This is based on the date of the most recent edit to the posting, being July 12th, 2022, as well as the date of the original posting, being August 1st, 2022. There are, however, 1850 other trials that are actively recruiting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Doravirine and Weight Gain in Antiretroviral Naive

2022. "Doravirine and Weight Gain in Antiretroviral Naive". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05457530.