CLINICAL TRIALS PROFILE FOR AMDOXOVIR

Clinical Trials for Amdoxovir

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00031044 ↗	Adding New Drugs for HIV Infected Patients Failing Current Therapy	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1/Phase 2	Even though powerful anti-HIV drug combinations have been successful in patients with little or no prior anti-HIV therapy, studies have shown that these treatments are less effective in patients who have been treated with nucleoside analogues. This study will test the safety and effectiveness of adding one or two new drugs to a personalized anti-HIV regimen for patients whose previous HIV treatments have failed.
NCT00038272 ↗	A Study of DAPD Alone Versus DAPD Plus MMF for Treatment of HIV Infection	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	The purpose of this study is to evaluate the safety, efficacy, and side effects of beta-D-2,6-diaminopurine dioxolane (DAPD) compared to DAPD plus mycophenolate mofetil (MMF) when these drugs are added to the anti-HIV treatment regimens of people infected with HIV. Some studies have shown that DAPD and MMF can help fight HIV. However, neither DAPD nor MMF has been approved by the Food and Drug Administration for treating HIV infection. This study will help doctors decide if DAPD and MMF are good drugs for treating HIV.
NCT00432016 ↗	Safety, Tolerance, Pharmacokinetic and Antiviral Study of Amdoxovir in Combination With Zidovudine in Adults With HIV	Completed	RFS Pharma, LLC	Phase 1/Phase 2	The purpose of this study is to determine the short term safety, tolerance, and antiviral effect of zidovudine (AZT) and amdoxovir (AMDX, DAPD) in combination, and whether the dosage for AZT can be reduced, potentially decreasing side effects, while maintaining antiviral effects. Study hypothesis: DADP in combination with AZT is safe and effective, and AZT dosing may be reduced, resulting in lower levels of AZT-monophosphate associated with toxicity and maintaining levels of AZT-triphosphate associated with efficacy.
NCT01737359 ↗	A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects.	Terminated	RFS Pharma, LLC	Phase 2	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.
NCT01738555 ↗	A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects	Withdrawn	RFS Pharma, LLC	Phase 2	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.

Clinical Trial Conditions for Amdoxovir

Condition Name

Condition Name for
Intervention	Trials
HIV Infections	3
Human Immunodeficiency Virus Infection	2

Condition MeSH

Condition MeSH for
Intervention	Trials
HIV Infections	5
Acquired Immunodeficiency Syndrome	3
Virus Diseases	2
Immunologic Deficiency Syndromes	2

Clinical Trial Locations for Amdoxovir

Trials by Country

Trials by Country for
Location	Trials
United States	16
Argentina	3
Puerto Rico	1

Trials by US State

Trials by US State for
Location	Trials
Ohio	2
New York	2
Florida	2
Colorado	2
Washington	1

Clinical Trial Progress for Amdoxovir

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 2	3
Phase 1/Phase 2	2

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Completed	3
Terminated	1
Withdrawn	1

Clinical Trial Sponsors for Amdoxovir

Sponsor Name

Sponsor Name for
Sponsor	Trials
RFS Pharma, LLC	3
National Institute of Allergy and Infectious Diseases (NIAID)	2

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	3
NIH	2