Overview

A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects

Status:
Withdrawn
Trial end date:
2014-10-01
Target enrollment:
Participant gender:
Summary
This study is an open-label extension of RFSP-AMDX-2010 study for those subjects who received treatment with amdoxovir (300 mg or 500 mg twice daily) for 12 weeks and benefited from it. This study will examine the safety and efficacy of the investigational HIV drug, amdoxovir (300 mg and 500 mg bid doses; N = up to 30) in combination with zidovudine and lopinavir/ritonavir for 36 weeks. Subjects will continue to receive either amdoxovir 300 mg twice daily or amdoxovir 500 mg twice daily, each in combination with zidovudine 300 mg twice daily and lopinavir/ritonavir (400 mg/100 mg twice daily) for additional 36 weeks.
Phase:
Phase 2
Details
Lead Sponsor:
RFS Pharma, LLC
Treatments:
Lopinavir
Ritonavir
Zidovudine