COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01738555
Recruitment Status : Withdrawn
First Posted : November 30, 2012
Last Update Posted : March 29, 2013
Information provided by (Responsible Party):
RFS Pharma, LLC

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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Infection Drug: amdoxovir 300 mg bid Drug: amdoxovir 500 mg bid Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : April 2013
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Zidovudine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. HIV-1 viral load [ Time Frame: up to 48 Weeks ]

Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: up to 48 Weeks ]
  2. Changes in Immunologic Function (CD4 cell counts) [ Time Frame: from baseline to Weeks 18, 24, 30, 36, 42, 48 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01738555

Sponsors and Collaborators
RFS Pharma, LLC
Layout table for investigator information
Study Director: Luz Pascual, MD MPH RFS Pharma, LLC

Layout table for additonal information
Responsible Party: RFS Pharma, LLC Identifier: NCT01738555    
Other Study ID Numbers: RFSP-AMDX-2012
First Posted: November 30, 2012    Key Record Dates
Last Update Posted: March 29, 2013
Last Verified: March 2013
Keywords provided by RFS Pharma, LLC:
Additional relevant MeSH terms:
Layout table for MeSH terms
Acquired Immunodeficiency Syndrome
HIV Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors