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

NCT01737359 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2014-11-05

No results posted yet for this study

Summary

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.

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

DRUG

tenofovir DF 300 mg qd

1 x 300 mg tablet once daily

Sponsors & Collaborators

  • RFS Pharma, LLC

    lead INDUSTRY

Principal Investigators

  • Luz Pascual, MD MPH · RFS Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-02-28
Completion
2013-03-31

Countries

  • Argentina

Study Locations

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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 NCT01737359 on ClinicalTrials.gov