drugset / Trial / NCT02032888
A Phase 3 Study to Evaluate Combination Therapy With Daclatasvir and Sofosbuvir in the Treatment of HIV and Hepatitis C Virus Coinfection.
RandomizedParallel-groupOpen-labelTreatment
Summary
A study of the efficacy and safety of the combination of daclatasvir and sofosbuvir in the treatment of hepatitis C virus and HIV coinfection.
Timeline
- Start
- 2014-02
- Primary completion
- 2014-10
- Completion
- 2015-01
Publications
- Luetkemeyer AF, McDonald C, Ramgopal M, Noviello S, Bhore R, Ackerman P. 12 Weeks of Daclatasvir in Combination With Sofosbuvir for HIV-HCV Coinfection (ALLY-2 Study): Efficacy and Safety by HIV Combination Antiretroviral Regimens. Clin Infect Dis. 2016 Jun 15;62(12):1489-96. doi: 10.1093/cid/ciw163. Epub 2016 Mar 29.
- Wyles DL, Ruane PJ, Sulkowski MS, Dieterich D, Luetkemeyer A, Morgan TR, Sherman KE, Dretler R, Fishbein D, Gathe JC Jr, Henn S, Hinestrosa F, Huynh C, McDonald C, Mills A, Overton ET, Ramgopal M, Rashbaum B, Ray G, Scarsella A, Yozviak J, McPhee F, Liu Z, Hughes E, Yin PD, Noviello S, Ackerman P; ALLY-2 Investigators. Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1. N Engl J Med. 2015 Aug 20;373(8):714-25. doi: 10.1056/NEJMoa1503153. Epub 2015 Jul 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daclatasvir | Small molecule | 30 mg | Oral |
| Subject | Daclatasvir | Small molecule | 60 mg | Oral |
| Subject | Daclatasvir | Small molecule | 90 mg | Oral |
| Subject | Sofosbuvir | Small molecule | 400 mg | Oral |