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

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ClinicalTrials.gov Identifier: NCT01737359
Recruitment Status : Terminated
First Posted : November 29, 2012
Last Update Posted : November 5, 2014
Sponsor:
Information provided by (Responsible Party):
RFS Pharma, LLC

Study Description
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Brief Summary:

This is a double-blind Phase 2a study to test the safety and efficacy of an investigational HIV drug, amdoxovir (300 mg or 500 mg twice daily) compared with tenofovir DF 300 mg once daily in HIV-1 infected antiretroviral therapy-experienced subjects who are currently failing antiretroviral therapy. There are three treatment groups (N=45). Subjects will be randomized to receive either amdoxovir 300 mg twice daily (n=15) or amdoxovir 500 mg twice daily (n=15) or tenofovir DF 300 mg once daily (n=15); each in combination with zidovudine 300 mg twice daily.

The study will assess initially amdoxovir (300 mg or 500 mg twice daily) or tenofovir DF 300 mg once daily, both in combination zidovudine 300 mg twice daily plus failing third drug, but then with lopinavir/ritonavir (400 mg/100 mg twice daily) after Week 2. Subjects who received amdoxovir (300 mg or 500 mg twice daily) and benefited from the drug may choose to enroll in the 36-week open-label study.


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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase IIa, Randomized, Double-blind, Active-controlled, 12-week Study of Amdoxovir (Two Doses) Versus Tenofovir DF, in Combination With Zidovudine in HIV-1 Treatment-experienced Subjects With M184I/V Mutation in Addition to 0-2 Confirmed Thymidine Analog Mutations.
Study Start Date : December 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: amdoxovir 300 mg bid
in combination with zidovudine 300 mg bid for 12 weeks; lopinavir/ritonavir (400 mg/100 mg) bid is added on week 3
 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 for 12 weeks; lopinavir/ritonavir (400 mg/100 mg) bid is added on week 3
 Drug: amdoxovir 500 mg bid
2 x 250 mg capsules bid
Other Names:
  • DAPD
  • AMDX
Active Comparator: tenofovir DF 300 mg qd
in combination with zidovudine 300 mg bid for 12 weeks; lopinavir/ritonavir (400 mg/100 mg) bid is added on week 3
 Drug: tenofovir DF 300 mg qd
1 x 300 mg tablet once daily
Other Name: Viread


Outcome Measures
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Primary Outcome Measures :
  1. HIV-1 viral load [ Time Frame: change from baseline to Week 2 ]
  2. Safety and Tolerability- Incidence of adverse events and laboratory abnormalities [ Time Frame: number and frequency from baseline through Week 12 ]

Secondary Outcome Measures :
  1. HIV-1 viral load [ Time Frame: change from baseline to Weeks 4, 8 and 12 ]
  2. Changes in Immunologic Function (CD4 cell counts) [ Time Frame: changes from baseline to Weeks 4, 8 and 12 ]

Eligibility Criteria
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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.


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

Inclusion Criteria:

  • Male or female ≥ 18 years old with HIV-1 RNA ≥ 2,000 copies/mL and currently failing therapy.
  • Has M184I/V mutation in addition to 0-2 thymidine analog mutations (TAMs) at screening.
  • Agree to be abstinent or use two reliable forms of contraception (for females) and one form for men when participating in sexual activity that could result in pregnancy.

Exclusion Criteria:

  • Current or recent (last 30 days of study entry) AIDS defining diseases.
  • Genotypic resistance testing at screening indicating K65R, L74V, Q151M mutation.
  • Prior exposure to lopinavir/ritonavir or amdoxovir.
  • Impaired hepatic function (ALT > 5 x ULN).
  • Women who are pregnant or breast feeding.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01737359


Locations
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Argentina
Research Site
Rosario, Santa Fe, Argentina, S2000CXP
Research Site
Rosario, Santa Fe, Argentina, S2000PBJ
Research Site
Buenos Aires, Argentina, C1141ACG
Research Site
Buenos Aires, Argentina, C1202ABB
Research Site
Buenos Aires, Argentina, C1405CKC
Research Site
Buenos Aires, Argentina, C1426EGR
Sponsors and Collaborators
RFS Pharma, LLC
Investigators
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Study Director: Luz Pascual, MD MPH RFS Pharma
More Information
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Responsible Party: RFS Pharma, LLC
ClinicalTrials.gov Identifier: NCT01737359    
Other Study ID Numbers: RFSP-AMDX-2010
First Posted: November 29, 2012    Key Record Dates
Last Update Posted: November 5, 2014
Last Verified: March 2013
Keywords provided by RFS Pharma, LLC:
amdoxovir
zidovudine
tenofovir DF
 HIV
HAART
antiretroviral
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Virus Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Slow Virus Diseases
Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents