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

March 27, 2013 updated by: RFS Pharma, LLC

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

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:

  • 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.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • DAPD
  • AMDX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HIV-1 viral load
Time Frame: up to 48 Weeks
up to 48 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events
Time Frame: up to 48 Weeks
up to 48 Weeks
Changes in Immunologic Function (CD4 cell counts)
Time Frame: from baseline to Weeks 18, 24, 30, 36, 42, 48
from baseline to Weeks 18, 24, 30, 36, 42, 48

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, LLC

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

April 1, 2013

Primary Completion (ANTICIPATED)

August 1, 2014

Study Completion (ANTICIPATED)

October 1, 2014

Study Registration Dates

First Submitted

November 28, 2012

First Submitted That Met QC Criteria

November 29, 2012

First Posted (ESTIMATE)

November 30, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 29, 2013

Last Update Submitted That Met QC Criteria

March 27, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RFSP-AMDX-2012

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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