drugset / Trial / NCT04880395
Dolutegravir-Lamivudine for naïve HIV-Infected Patients With ≤200 CD4/mm3
Phase 4
Completed
265 enrolled
Fundación Huésped
Federal University of Bahia · collabViiV Healthcare · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Protocol Title: DOLCE: Dolutegravir-Lamivudine for naïve HIV-Infected Patients with ≤200 CD4/mm3 Protocol Number: FH-57 Study Objectives: To assess the antiviral activity at week 48 of DTG+3TC among naïve HIV patients with a CD4 count ≤200 cells /mm3.
Timeline
- Start
- 2021-05-17
- Primary completion
- 2024-05-07
- Completion
- 2024-05-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dolutegravir | Other / unclassified | 50 mg | — |
| Subject | Lamivudine | Other / unclassified | 300 mg | — |
| Comparator | Tenofovir disoproxil fumarate | Small molecule | 300 mg | — |
| Comparator | emtricitabine | Other / unclassified | 200 mg | — |