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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
RFS Pharma, LLC
ClinicalTrials.gov Identifier:
NCT01738555
First received: November 28, 2012
Last updated: March 27, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Human Immunodeficiency Virus Infection
 Drug: amdoxovir 300 mg bid
Drug: amdoxovir 500 mg bid
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by RFS Pharma, LLC:

Primary Outcome Measures:
  • HIV-1 viral load [ Time Frame: up to 48 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse events [ Time Frame: up to 48 Weeks ] [ Designated as safety issue: Yes ]
  • Changes in Immunologic Function (CD4 cell counts) [ Time Frame: from baseline to Weeks 18, 24, 30, 36, 42, 48 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: April 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: amdoxovir 300 mg bid
in combination with zidovudine 300 mg bid and lopinavir/ritonavir (400 mg/100 mg bid) for 36 weeks.
 Drug: amdoxovir 300 mg bid
2 x 150 mg capsules bid
Other Names:
  • DAPD
  • AMDX
Experimental: amdoxovir 500 mg bid
in combination with zidovudine 300 mg bid and lopinavir/ritonavir (400 mg/100 mg bid) for 36 weeks.
 Drug: amdoxovir 500 mg bid
2 x 250 mg capsules bid
Other Names:
  • DAPD
  • AMDX

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01738555

Sponsors and Collaborators
RFS Pharma, LLC
Investigators
Study Director: Luz Pascual, MD MPH RFS Pharma, LLC
  More Information

No publications provided

Responsible Party: RFS Pharma, LLC
ClinicalTrials.gov Identifier: NCT01738555     History of Changes
Other Study ID Numbers: RFSP-AMDX-2012
Study First Received: November 28, 2012
Last Updated: March 27, 2013
Health Authority: United States: Food and Drug Administration
Argentina: ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica)

Keywords provided by RFS Pharma, LLC:
amdoxovir
zidovudine
HIV
HAART
antiretroviral

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Virus Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Zidovudine
Lopinavir
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
HIV Protease Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013