Doravirine for Obese Persons on Integrase Inhibitors and Tenofovir Alafenamide
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
Outcome
Missed primary endpoint
registry analysis (superiority test); DOR 100 mg + TAF/FTC vs Continuation of INSTI+TAF/FTC; p = 0.23; NCT04636437 ↗
registry analysis (superiority test); DOR 100 mg + TDF/FTC vs Continuation of INSTI+TAF/FTC; p = 0.41; NCT04636437 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bictegravir | Small molecule | — | Oral |
| Subject | Dolutegravir | Other / unclassified | — | Oral |
| Subject | Doravirine | Small molecule | 100 mg | Oral |
| Subject | Raltegravir | Other / unclassified | — | Oral |
| Subject | Tenofovir disoproxil fumarate | Small molecule | — | Oral |
| Comparator | tenofovir alafenamide | Small molecule | — | Oral |
| Comparator | emtricitabine | Other / unclassified | — | Oral |