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

November 4, 2014 updated by: RFS Pharma, LLC

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1202ABB
        • Research Site
      • Buenos Aires, Argentina, C1141ACG
        • Research Site
      • Buenos Aires, Argentina, C1405CKC
        • Research Site
      • Buenos Aires, Argentina, C1426EGR
        • Research Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000PBJ
        • Research Site
      • Rosario, Santa Fe, Argentina, S2000CXP
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • Viread

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RFS Pharma, LLC

Investigators

  • Study Director: Luz Pascual, MD MPH, RFS Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

November 27, 2012

First Submitted That Met QC Criteria

November 27, 2012

First Posted (Estimate)

November 29, 2012

Study Record Updates

Last Update Posted (Estimate)

November 5, 2014

Last Update Submitted That Met QC Criteria

November 4, 2014

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RFSP-AMDX-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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