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| Name | Class |
|---|---|
| Achillion, a wholly owned subsidiary of Alexion | INDUSTRY |
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To assess the safety of 48 weeks of treatment with 10 milligrams (mg) of elvucitabine in combination with background antiretroviral therapy (ART) in participants who completed Study ACH443-014A and meet the inclusion and exclusion criteria.
This study is an open-label extension study for participants who have completed 14 days of treatment in Study ACH443-014A and meet all inclusion and exclusion criteria. Elvucitabine treatment (10 mg) will begin on Day 1 (Day 15 following completion of Study ACH443-014A) for all consenting participants in combination with background ART as determined by the Principal Investigator. Participants will have clinical and laboratory assessments every 2 weeks for the first 8 weeks and then every 4 weeks to Week 48.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elvucitabine | Drug | Elvucitabine 10 mg in combination with background ART | ||
| Lamivudine | Drug | |||
| Emtricitabine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To Assess The Safety Of 48 Weeks Of 10 mg/daily (QD) Of Elvucitabine In Combination With ART | September 2008 |
| Measure | Description | Time Frame |
|---|---|---|
| To Describe The Anti-viral Activity Of Elvucitabine In Combination With ART As Measured By Plasma HIV-1 Ribonucleic Acid (RNA) Over 24 Weeks | September 2008 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Atlanta | Georgia | 30308 | United States | ||
| Clinical Trial Site |
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| Cincinnati |
| Ohio |
| 45242 |
| United States |
| Clinical Trial Site | Santo Domingo | Dominican Republic |
| Clinical Trial Site | Berlin | Germany |
| Clinical Trial Site | Bonn | Germany |
| Clinical Trial Site | Cologne | Germany |
| Clinical Trial Site | Madrid | Spain |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| 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 |
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| ID | Term |
|---|---|
| C099405 | dexelvucitabine |
| D019259 | Lamivudine |
| D000068679 | Emtricitabine |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
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