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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| amdoxovir 300 mg bid | Experimental | in combination with zidovudine 300 mg bid and lopinavir/ritonavir (400 mg/100 mg bid) for 36 weeks. |
|
| amdoxovir 500 mg bid | Experimental | in combination with zidovudine 300 mg bid and lopinavir/ritonavir (400 mg/100 mg bid) for 36 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| amdoxovir 300 mg bid | Drug | 2 x 150 mg capsules bid |
|
| Measure | Description | Time Frame |
|---|---|---|
| HIV-1 viral load | up to 48 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | up to 48 Weeks | |
| Changes in Immunologic Function (CD4 cell counts) | from baseline to Weeks 18, 24, 30, 36, 42, 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luz Pascual, MD MPH | RFS Pharma, LLC | Study Director |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C098393 | amdoxovir |
| C494814 | BID protein, human |
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| amdoxovir 500 mg bid | Drug | 2 x 250 mg capsules bid |
|
|
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |