drugset / Trial / NCT04022967
ANRS 12372 MODERATO Study
RandomizedParallel-groupOpen-labelTreatment
Summary
MODERATO is a phase III, open-label, randomized, multicenter, non-inferiority trial conducted in West and Central Africa (Cameroon, Côte d'Ivoire, Burkina Faso). HIV-1 infected adults receiving first line ART with TDF+XTC+EFV or DTG+XTC+TDF virologically suppressed will be recruited and followed during 100 weeks. The objective is to assess the non-inferiority of a strategy consisting of switching to a dual maintenance therapy (DTG+3TC or ATV/r+3TC), comparing to WHO standard first line regimen (TDF+3TC+EFV or DTG+3TC+TDF), in terms of virological success at 96 weeks
Timeline
- Start
- 2020-09-21
- Primary completion
- 2025-02-05
- Completion
- 2025-02-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atazanavir | Other / unclassified | 300 mg | Oral |
| Subject | Dolutegravir | Other / unclassified | 50 mg | Oral |
| Comparator | Efavirenz | Other / unclassified | 400 mg | Oral |
| Comparator | Tenofovir | Small molecule | 245 mg | Oral |
| Comparator | Tenofovir | Small molecule | 300 mg | Oral |
| Background | Lamivudine | Other / unclassified | 300 mg | Oral |
| Background | Ritonavir | Other / unclassified | 100 mg | Oral |