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

NCT01738555 | Withdrawn Phase 2

• 1 other identifier: RFSP-AMDX-2012
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

amdoxovir; zidovudine; HIV; HAART; antiretroviral

Outcome Measures

Primary Outcomes (1)

• HIV-1 viral load

  up to 48 Weeks

Secondary Outcomes (2)

• Incidence of adverse events

  up to 48 Weeks

• Changes in Immunologic Function (CD4 cell counts)

  from baseline to Weeks 18, 24, 30, 36, 42, 48

Study Arms (2)

amdoxovir 300 mg bid

EXPERIMENTAL

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

Drug: amdoxovir 300 mg bid

amdoxovir 500 mg bid

EXPERIMENTAL

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

Drug: amdoxovir 500 mg bid

Interventions

amdoxovir 300 mg bid DRUG

2 x 150 mg capsules bid

Also known as: DAPD, AMDX

amdoxovir 300 mg bid

amdoxovir 500 mg bid DRUG

2 x 250 mg capsules bid

Also known as: DAPD, AMDX

amdoxovir 500 mg bid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RFS Pharma, LLC: lead

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

amdoxovir; BID protein, human

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Luz Pascual, MD MPH

  RFS Pharma, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: November 30, 2012
• Study Start: April 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 29, 2013

Record last verified: 2013-03