drugset / Trial / NCT02770508
Darunavir/Ritonavir + Lamivudine Versus Darunavir/Ritonavir +Emtricitabine/Tenofovir in Naïve HIV-1 Infected Subjects
Phase 4
Completed
145 enrolled
Fundación Huésped
Ministry of Science and Technology,Argentine · collabNational AIDS and STD programme,Argentine · collabRichmond Laboratories · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare the safety and efficacy of a combination of a QD regimen consisting on ritonavir boosted darunavir (FDC) and lamivudine versus ritonavir boosted darunavir (FDC) plus co-formulated tenofovir and emtricitabine or co-formulated tenofovir/lamivudine in naïve HIV-1 infected patients. Subjects will be ARV-naïve HIV-1-infected patients eligible to start ARV therapy according to current guidelines.Subjects will be adults ≥ 18 years of age who meet all of the inclusion criteria and none of the exclusion criteria.
Timeline
- Start
- 2015-11
- Primary completion
- 2017-07
- Completion
- 2017-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lamivudine | Other / unclassified | 300 mg | Oral |
| Comparator | Tenofovir | Small molecule | 300 mg | Oral |
| Comparator | emtricitabine | Other / unclassified | 200 mg | Oral |
| Background | Darunavir | Small molecule | 800 mg | Oral |
| Background | Ritonavir | Other / unclassified | 100 mg | Oral |