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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
RFS Pharma, LLC
ClinicalTrials.gov Identifier:
NCT01737359
First received: November 27, 2012
Last updated: November 4, 2014
Last verified: March 2013

November 27, 2012
November 4, 2014
December 2012
February 2013   (final data collection date for primary outcome measure)
  • HIV-1 viral load [ Time Frame: change from baseline to Week 2 ] [ Designated as safety issue: No ]
  • Safety and Tolerability- Incidence of adverse events and laboratory abnormalities [ Time Frame: number and frequency from baseline through Week 12 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01737359 on ClinicalTrials.gov Archive Site
  • HIV-1 viral load [ Time Frame: change from baseline to Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
  • Changes in Immunologic Function (CD4 cell counts) [ Time Frame: changes from baseline to Weeks 4, 8 and 12 ] [ 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.
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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
  • Drug: tenofovir DF 300 mg qd
    1 x 300 mg tablet once daily
    Other Name: Viread
  • 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
    Intervention: Drug: amdoxovir 300 mg bid
  • 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
    Intervention: Drug: amdoxovir 500 mg bid
  • 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
    Intervention: Drug: tenofovir DF 300 mg qd
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
March 2013
February 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina
 
NCT01737359
RFSP-AMDX-2010
No
RFS Pharma, LLC
RFS Pharma, LLC
Not Provided
Study Director: Luz Pascual, MD MPH RFS Pharma
RFS Pharma, LLC
March 2013

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