A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects.
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ClinicalTrials.gov Identifier: NCT01737359 |
Recruitment Status :
Terminated
First Posted : November 29, 2012
Last Update Posted : November 5, 2014
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Human Immunodeficiency Virus Infection | Drug: amdoxovir 300 mg bid Drug: amdoxovir 500 mg bid Drug: tenofovir DF 300 mg qd | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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. |
Study Start Date : | December 2012 |
Actual Primary Completion Date : | February 2013 |
Actual Study Completion Date : | March 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: amdoxovir 300 mg bid
in combination with zidovudine 300 mg bid for 12 weeks; lopinavir/ritonavir (400 mg/100 mg) bid is added on week 3
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Drug: amdoxovir 300 mg bid
2 x 150 mg capsules bid
Other Names:
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Experimental: amdoxovir 500 mg bid
in combination with zidovudine 300 mg bid for 12 weeks; lopinavir/ritonavir (400 mg/100 mg) bid is added on week 3
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Drug: amdoxovir 500 mg bid
2 x 250 mg capsules bid
Other Names:
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Active Comparator: tenofovir DF 300 mg qd
in combination with zidovudine 300 mg bid for 12 weeks; lopinavir/ritonavir (400 mg/100 mg) bid is added on week 3
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Drug: tenofovir DF 300 mg qd
1 x 300 mg tablet once daily
Other Name: Viread |
- HIV-1 viral load [ Time Frame: change from baseline to Week 2 ]
- Safety and Tolerability- Incidence of adverse events and laboratory abnormalities [ Time Frame: number and frequency from baseline through Week 12 ]
- HIV-1 viral load [ Time Frame: change from baseline to Weeks 4, 8 and 12 ]
- Changes in Immunologic Function (CD4 cell counts) [ Time Frame: changes from baseline to Weeks 4, 8 and 12 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01737359
Argentina | |
Research Site | |
Rosario, Santa Fe, Argentina, S2000CXP | |
Research Site | |
Rosario, Santa Fe, Argentina, S2000PBJ | |
Research Site | |
Buenos Aires, Argentina, C1141ACG | |
Research Site | |
Buenos Aires, Argentina, C1202ABB | |
Research Site | |
Buenos Aires, Argentina, C1405CKC | |
Research Site | |
Buenos Aires, Argentina, C1426EGR |
Study Director: | Luz Pascual, MD MPH | RFS Pharma |
Responsible Party: | RFS Pharma, LLC |
ClinicalTrials.gov Identifier: | NCT01737359 |
Other Study ID Numbers: |
RFSP-AMDX-2010 |
First Posted: | November 29, 2012 Key Record Dates |
Last Update Posted: | November 5, 2014 |
Last Verified: | March 2013 |
amdoxovir zidovudine tenofovir DF |
HIV HAART antiretroviral |
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Immune System Diseases Virus Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Slow Virus Diseases Tenofovir Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents |