MedTrace Logo

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

NCT01738555 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2013-03-29

No results posted yet for this study

Summary

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.

Conditions

  • Human Immunodeficiency Virus Infection

Interventions

DRUG

amdoxovir 300 mg bid

2 x 150 mg capsules bid

DRUG

amdoxovir 500 mg bid

2 x 250 mg capsules bid

Sponsors & Collaborators

  • RFS Pharma, LLC

    lead INDUSTRY

Principal Investigators

  • Luz Pascual, MD MPH · RFS Pharma, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-08-31
Completion
2014-10-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01738555 on ClinicalTrials.gov