Human Immunodeficiency Virus Infection Clinical Trial
Official title:
An Open-label, 36-week Extension Study on Amdoxovir at 500 mg Bid or 300 mg Bid in Combination With Zidovudine and Lopinavir/Ritonavir in HIV-1 Treatment-experienced Subjects With M184I/V Mutation in Addition to 0-2 Confirmed Thymidine Analog Mutations.
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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