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

NCT01737359 | Terminated Phase 2

• 1 other identifier: RFSP-AMDX-2010
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

amdoxovir; zidovudine; tenofovir DF; HIV; HAART; antiretroviral

Outcome Measures

Primary Outcomes (2)

• HIV-1 viral load

  change from baseline to Week 2

• Safety and Tolerability- Incidence of adverse events and laboratory abnormalities

  number and frequency from baseline through Week 12

Secondary Outcomes (2)

• HIV-1 viral load

  change from baseline to Weeks 4, 8 and 12

• Changes in Immunologic Function (CD4 cell counts)

  changes from baseline to Weeks 4, 8 and 12

Study Arms (3)

amdoxovir 300 mg bid

EXPERIMENTAL

in combination with zidovudine 300 mg bid for 12 weeks; lopinavir/ritonavir (400 mg/100 mg) bid is added on week 3

Drug: amdoxovir 300 mg bid

amdoxovir 500 mg bid

EXPERIMENTAL

in combination with zidovudine 300 mg bid for 12 weeks; lopinavir/ritonavir (400 mg/100 mg) bid is added on week 3

Drug: amdoxovir 500 mg bid

tenofovir DF 300 mg qd

ACTIVE COMPARATOR

in combination with zidovudine 300 mg bid for 12 weeks; lopinavir/ritonavir (400 mg/100 mg) bid is added on week 3

Drug: tenofovir DF 300 mg qd

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

tenofovir DF 300 mg qd DRUG

1 x 300 mg tablet once daily

Also known as: Viread

tenofovir DF 300 mg qd

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RFS Pharma, LLC: lead

Study Sites (6)

Research Site

Buenos Aires, Buenos Aires, C1141ACG, Argentina

Location

Research Site

Buenos Aires, Buenos Aires, C1202ABB, Argentina

Location

Research Site

Buenos Aires, Buenos Aires, C1405CKC, Argentina

Location

Research Site

Buenos Aires, Buenos Aires, C1426EGR, Argentina

Location

Research Site

Rosario, Santa Fe Province, S2000CXP, Argentina

Location

Research Site

Rosario, Santa Fe Province, S2000PBJ, Argentina

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

amdoxovir; BID protein, human; Tenofovir

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

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Luz Pascual, MD MPH

  RFS Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: November 29, 2012
• Study Start: December 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: March 1, 2013
• Last Updated: November 5, 2014

Record last verified: 2013-03

Locations

AR (6)