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This study has been withdrawn prior to enrollment.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

November 28, 2012
March 27, 2013
April 2013
August 2014   (final data collection date for primary outcome measure)
HIV-1 viral load [ Time Frame: up to 48 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01738555 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Human Immunodeficiency Virus Infection
  • Drug: amdoxovir 300 mg bid
    2 x 150 mg capsules bid
    Other Names:
    • DAPD
    • AMDX
  • Drug: amdoxovir 500 mg bid
    2 x 250 mg capsules bid
    Other Names:
    • DAPD
    • AMDX
  • Experimental: amdoxovir 300 mg bid
    in combination with zidovudine 300 mg bid and lopinavir/ritonavir (400 mg/100 mg bid) for 36 weeks.
    Intervention: Drug: amdoxovir 300 mg bid
  • Experimental: amdoxovir 500 mg bid
    in combination with zidovudine 300 mg bid and lopinavir/ritonavir (400 mg/100 mg bid) for 36 weeks.
    Intervention: Drug: amdoxovir 500 mg bid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
October 2014
August 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01738555
RFSP-AMDX-2012
No
RFS Pharma, LLC
RFS Pharma, LLC
Not Provided
Study Director: Luz Pascual, MD MPH RFS Pharma, LLC
RFS Pharma, LLC
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP