Back to resultsA Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects
Primary Purpose
Human Immunodeficiency Virus Infection
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
amdoxovir 300 mg bid
amdoxovir 500 mg bid
Sponsored by
About this trial
This is an interventional treatment trial for Human Immunodeficiency Virus Infection focused on measuring amdoxovir, zidovudine, HIV, HAART, antiretroviral
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
amdoxovir 300 mg bid
amdoxovir 500 mg bid
Arm Description
in combination with zidovudine 300 mg bid and lopinavir/ritonavir (400 mg/100 mg bid) for 36 weeks.
in combination with zidovudine 300 mg bid and lopinavir/ritonavir (400 mg/100 mg bid) for 36 weeks.
Outcomes
Primary Outcome Measures
HIV-1 viral load
Secondary Outcome Measures
Incidence of adverse events
Changes in Immunologic Function (CD4 cell counts)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01738555
Brief Title
A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Withdrawn
Study Start Date
April 2013 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RFS Pharma, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus Infection
Keywords
amdoxovir, zidovudine, HIV, HAART, antiretroviral
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
amdoxovir 300 mg bid
Arm Type
Experimental
Arm Description
in combination with zidovudine 300 mg bid and lopinavir/ritonavir (400 mg/100 mg bid) for 36 weeks.
Arm Title
amdoxovir 500 mg bid
Arm Type
Experimental
Arm Description
in combination with zidovudine 300 mg bid and lopinavir/ritonavir (400 mg/100 mg bid) for 36 weeks.
Intervention Type
Drug
Intervention Name(s)
amdoxovir 300 mg bid
Other Intervention Name(s)
DAPD, AMDX
Intervention Description
2 x 150 mg capsules bid
Intervention Type
Drug
Intervention Name(s)
amdoxovir 500 mg bid
Other Intervention Name(s)
DAPD, AMDX
Intervention Description
2 x 250 mg capsules bid
Primary Outcome Measure Information:
Title
HIV-1 viral load
Time Frame
up to 48 Weeks
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
up to 48 Weeks
Title
Changes in Immunologic Function (CD4 cell counts)
Time Frame
from baseline to Weeks 18, 24, 30, 36, 42, 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luz Pascual, MD MPH
Organizational Affiliation
RFS Pharma, LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects
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