Clinical Trials


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

This study has been withdrawn
RFS Pharma, LLC

Information provided by (Responsible Party)
RFS Pharma, LLC Identifier

First received: November 28, 2012
Last updated: March 27, 2013
Last Verified: March 2013
History of Changes


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
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.

Further study details as provided by RFS Pharma, LLC:

Primary Outcome Measures

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

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 Name:
  • 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 Name:
  • DAPD
  • AMDX



Ages Eligible for Study: 18 Years and older  
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.

contacts and locations

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01738555

Sponsors and Collaborators

RFS Pharma, LLC


Study Director: Luz Pascual, MD MPH RFS Pharma, LLC
More Information

More Information

Responsible Party: RFS Pharma, LLC Identifier: NCT01738555   History of Changes  
Other Study ID Numbers: RFSP-AMDX-2012  
Study First Received: November 28, 2012  
Last Updated: March 27, 2013  

Keywords provided by RFS Pharma, LLC:


Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Virus Diseases
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