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

NCT ID: NCT01738555

Last Updated: 2013-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Human Immunodeficiency Virus Infection

Keywords

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amdoxovir zidovudine HIV HAART antiretroviral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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amdoxovir 300 mg bid

in combination with zidovudine 300 mg bid and lopinavir/ritonavir (400 mg/100 mg bid) for 36 weeks.

Group Type EXPERIMENTAL

amdoxovir 300 mg bid

Intervention Type DRUG

2 x 150 mg capsules bid

amdoxovir 500 mg bid

in combination with zidovudine 300 mg bid and lopinavir/ritonavir (400 mg/100 mg bid) for 36 weeks.

Group Type EXPERIMENTAL

amdoxovir 500 mg bid

Intervention Type DRUG

2 x 250 mg capsules bid

Interventions

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amdoxovir 300 mg bid

2 x 150 mg capsules bid

Intervention Type DRUG

amdoxovir 500 mg bid

2 x 250 mg capsules bid

Intervention Type DRUG

Other Intervention Names

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DAPD AMDX DAPD AMDX

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RFS Pharma, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luz Pascual, MD MPH

Role: STUDY_DIRECTOR

RFS Pharma, LLC

Other Identifiers

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RFSP-AMDX-2012

Identifier Type: -

Identifier Source: org_study_id