drugset / Trial / NCT05630638
Doravirine Dose Optimisation in Pregnancy
Phase 4
Recruiting
76 enrolled
University of Liverpool
Desmond Tutu Health Foundation · collabLiverpool School of Tropical Medicine · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
A randomised, open label, controlled PK standard of care vs doravirine plus 2 nucleoside reverse transcriptase inhibitors backbone in pregnant women initiating combination antiretroviral therapy in the second trimester of pregnancy.
Timeline
- Start
- 2023-10-10
- Primary completion
- 2028-07
- Completion
- 2028-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dolutegravir | Other / unclassified | 50 mg | — |
| Subject | Doravirine | Small molecule | 100 mg | — |
| Comparator | Lamivudine | Other / unclassified | 300 mg | — |
| Comparator | Tenofovir disoproxil fumarate | Small molecule | 245 mg | — |