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

Human Immunodeficiency Virus Infection Clinical Trial

Official title:

A Phase IIa, Randomized, Double-blind, Active-controlled, 12-week Study of Amdoxovir (Two Doses) Versus Tenofovir DF, in Combination With Zidovudine in HIV-1 Treatment-experienced Subjects With M184I/V Mutation in Addition to 0-2 Confirmed Thymidine Analog Mutations.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01737359
• Other study ID #: RFSP-AMDX-2010
• Status: Terminated
• Phase: Phase 2
• First received: November 27, 2012
• Last updated: November 4, 2014
• Start date: December 2012
• Est. completion date: March 2013

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: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female = 18 years old with HIV-1 RNA = 2,000 copies/mL and currently failing therapy.

• Has M184I/V mutation in addition to 0-2 thymidine analog mutations (TAMs) at screening.

• Agree to be abstinent or use two reliable forms of contraception (for females) and one form for men when participating in sexual activity that could result in pregnancy.

Exclusion Criteria:

• Current or recent (last 30 days of study entry) AIDS defining diseases.

• Genotypic resistance testing at screening indicating K65R, L74V, Q151M mutation.

• Prior exposure to lopinavir/ritonavir or amdoxovir.

• Impaired hepatic function (ALT > 5 x ULN).

• Women who are pregnant or breast feeding.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), 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
• tenofovir DF 300 mg qd
1 x 300 mg tablet once daily

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Rosario	Santa Fe
Argentina	Research Site	Rosario	Santa Fe

Sponsors (1)

Lead Sponsor	Collaborator
RFS Pharma, LLC

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV-1 viral load		change from baseline to Week 2	No
Primary	Safety and Tolerability- Incidence of adverse events and laboratory abnormalities		number and frequency from baseline through Week 12	Yes
Secondary	HIV-1 viral load		change from baseline to Weeks 4, 8 and 12	No
Secondary	Changes in Immunologic Function (CD4 cell counts)		changes from baseline to Weeks 4, 8 and 12	No