drugset / Trial / NCT04636437
Doravirine for Obese Persons on Integrase Inhibitors and Tenofovir Alafenamide
Phase 4
Completed
147 enrolled
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
National Institute of Allergy and Infectious Diseases (NIAID) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study was to determine if people with HIV and obesity taking an antiretroviral treatment regimen containing an integrase strand transfer inhibitor (INSTI) with (tenofovir alafenamide/emtricitabine (TAF/FTC) would either slow their rate of weight gain, or even lose weight, over the span of about 1 year after a switch to a regimen containing doravirine (DOR; a newer, non-nucleoside reverse transcriptase inhibitor medication) combined with either TAF/TFC or tenofovir disoproxil fumarate (TDF)/FTC.
Timeline
- Start
- 2021-07-27
- Primary completion
- 2024-10-18
- Completion
- 2024-10-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dolutegravir | Other / unclassified | — | Oral |
| Subject | Doravirine | Small molecule | 100 mg | Oral |
| Subject | Raltegravir | Other / unclassified | — | Oral |
| Subject | Tenofovir disoproxil fumarate | Small molecule | — | Oral |
| Subject | bictegravir | Small molecule | — | Oral |
| Comparator | tenofovir alafenamide | Small molecule | — | Oral |
| Comparator | emtricitabine | Other / unclassified | — | Oral |