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

Human Immunodeficiency Virus Infection Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01738555
• Other study ID #: RFSP-AMDX-2012
• Status: Withdrawn
• Phase: Phase 2
• First received: November 28, 2012
• Last updated: March 27, 2013
• Start date: April 2013
• Est. completion date: October 2014

Study information

• Verified date: March 2013
• Source: RFS Pharma, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus Infection
• Immunologic Deficiency Syndromes
• Virus Diseases

Intervention

Drug:
• amdoxovir 300 mg bid
2 x 150 mg capsules bid
• amdoxovir 500 mg bid
2 x 250 mg capsules bid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RFS Pharma, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV-1 viral load		up to 48 Weeks	No
Secondary	Incidence of adverse events		up to 48 Weeks	Yes
Secondary	Changes in Immunologic Function (CD4 cell counts)		from baseline to Weeks 18, 24, 30, 36, 42, 48	No