Overview

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

Status:
Withdrawn
Trial end date:
2014-10-01
Target enrollment:
0
Participant gender:
All
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
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
RFS Pharma, LLC
Treatments:
Lopinavir
Ritonavir
Zidovudine
Criteria
Inclusion Criteria:

- Must have completed Study RFSP-AMDX-2010 and received treatment with amdoxovir (500 mg
bid or 300 mg bid) for 12 weeks before entry into study RFSP-AMDX-2012.

- Must have maintained ≥ 1.0 log10 copies/mL from baseline at Week 12 in Study
RFSP-AMDX-2010.

- Must not have had any serious adverse experience since enrollment in Study
RFSP-AMDX-2010, whether or not considered to be study drug-related.

Exclusion Criteria:

- Subjects who require ongoing therapy of nephrotoxic drugs or competitors of renal
excretion.

- Subjects who require therapy with hematologic, bone marrow suppressive or cytotoxic
agents.

- Subjects who require medications that are highly dependent on CYP3A for clearance and
for which elevated plasma concentrations are associated with life-threatening adverse
events.

- Known allergy/sensitivity or any hypersensitivity to components of study drugs or
their formulations.

- Women who are pregnant or breastfeeding.