Last reviewed · How we verify
NCT05457530: DAWN
Doravirine and Weight Gain in Antiretroviral Naive
Phase 3 trial testing DOR/3TC/TDF in Body Weight Changes. Withdrawn.
3 May 2023
Quick facts
| Lead sponsor | Prism Health North Texas |
|---|---|
| Phase | Phase 3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Start date | 1 August 2022 |
| Primary completion | 3 May 2023 |
| Estimated completion | 3 May 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- DOR/3TC/TDF — full drug profile →
- DOR + FTC/TAF
- BIC/FTC/TAF — full drug profile →
Conditions studied
- Body Weight Changes — all drugs for Body Weight Changes →
- Human Immunodeficiency Virus — all drugs for Human Immunodeficiency Virus →
- ART — all drugs for ART →
- Obesity — all drugs for Obesity →
Sponsor
Prism Health North Texas — full company profile →
Who can join
18 and older, female only, with Body Weight Changes or Human Immunodeficiency Virus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05457530
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of DOR/3TC/TDF
Trials testing the same drug.
- NCT07075146 — DOR/TDF/3TC COmpared With BIC/FTC/TAF in ART-Naïve People Living With HIV and Overweight or Obesity · Phase 3 · recruiting
- NCT04665375 — Can INSTI-associated Weight Gain be Halted or Reversed With a Switch to Doravirine/Lamivudine/Tenofovir DF? · Phase 4 · terminated
- NCT04375800 — Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-0 · Phase 2 · recruiting
Other recruiting trials for Body Weight Changes
Currently open trials in the same condition.
- NCT06464497 — Whole Foods for Teens: A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity · NA · recruiting
- NCT06777498 — The Precision Nutrition New York Study · NA · recruiting
- NCT05644717 — Effect of Erugliflozin On Liver Fat, Liver Fibrosis and Glycemic Control in Type II DM Patients With NASH/NAFLD · Phase 4 · recruiting
- NCT05220709 — Bio Impedance Monitoring as a Tool to Assess Fluid Status in the Pediatric Surgical Patient? (PedFluid Study) · NA · recruiting
- NCT06534567 — Body Composition, Growth, and Maturation of Triathletes · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05457530 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Prism Health North Texas
- Last refreshed: 12 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05457530.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing