drugset / Trial / NCT01709084
A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus TDF/FTC/Efavirenz (TDF/FTC/EFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to demonstrate noninferiority (a new treatment is equivalent to standard treatment) in terms of the percentage of patients who have plasma human immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) levels less than 400 copies per mL after 48 weeks of randomized treatment with tenofovir disoproxil fumarate/emtricitabine/rilpivirine (TDF/FTC/RPV) versus TDF/FTC/efavirenz (TDF/FTC/EFV).
Timeline
- Start
- 2013-10-02
- Primary completion
- 2015-10-22
- Completion
- 2020-07-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Efavirenz | Other / unclassified | 600 mg | Oral |
| Subject | Rilpivirine | Small molecule | 25 mg | Oral |
| Background | Tenofovir disoproxil fumarate | Small molecule | 300 mg | Oral |
| Background | emtricitabine | Other / unclassified | 200 mg | Oral |