drugset / Trial / NCT02469246
Switch Study to Evaluate F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed on Regimens Containing ABC/3TC
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of switching abacavir/lamivudine (ABC/3TC) fixed-dose combination (FDC) tablets to emtricitabine/tenofovir alafenamide (F/TAF) FDC tablets versus maintaining ABC/3TC in human immunodeficiency virus type 1 (HIV-1) infected adults who are virologically suppressed on regimens containing ABC/3TC.
Timeline
- Start
- 2015-06-29
- Primary completion
- 2017-12-11
- Completion
- 2019-03-13
Outcome
Met primary endpoint
paper difference -3·0%, 95% CI -8·2 to 2·0), showing non-inferiority. PMID 29475804 ↗
Publications
- Results Winston A, Post FA, DeJesus E, Podzamczer D, Di Perri G, Estrada V, Raffi F, Ruane P, Peyrani P, Crofoot G, Mallon PWG, Castelli F, Yan M, Cox S, Das M, Cheng A, Rhee MS. Tenofovir alafenamide plus emtricitabine versus abacavir plus lamivudine for treatment of virologically suppressed HIV-1-infected adults: a randomised, double-blind, active-controlled, non-inferiority phase 3 trial. Lancet HIV. 2018 Apr;5(4):e162-e171. doi: 10.1016/S2352-3018(18)30010-9. Epub 2018 Feb 20.
- Results Gupta SK, Post FA, Arribas JR, Eron JJ Jr, Wohl DA, Clarke AE, Sax PE, Stellbrink HJ, Esser S, Pozniak AL, Podzamczer D, Waters L, Orkin C, Rockstroh JK, Mudrikova T, Negredo E, Elion RA, Guo S, Zhong L, Carter C, Martin H, Brainard D, SenGupta D, Das M. Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. AIDS. 2019 Jul 15;33(9):1455-1465. doi: 10.1097/QAD.0000000000002223.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Abacavir | Other / unclassified | 600 mg | Oral |
| Comparator | Lamivudine | Other / unclassified | 300 mg | Oral |
| Subject | emtricitabine | Other / unclassified | 200 mg | Oral |
| Subject | tenofovir alafenamide | Small molecule | 10 mg | Oral |
| Subject | tenofovir alafenamide | Small molecule | 25 mg | Oral |
| Background | Atazanavir | Other / unclassified | — | — |
| Background | Cobicistat | Small molecule | — | — |
| Background | Darunavir | Small molecule | — | — |
| Background | Dolutegravir | Other / unclassified | — | — |
| Background | Efavirenz | Other / unclassified | — | — |
| Background | Lopinavir | Other / unclassified | — | — |
| Background | Maraviroc | Other / unclassified | — | — |
| Background | Nevirapine | Small molecule | — | — |
| Background | Raltegravir | Other / unclassified | — | — |
| Background | Rilpivirine | Small molecule | — | — |
| Background | Ritonavir | Other / unclassified | — | — |