An Open Label Treatment Protocol to Provide Continued Elvucitabine Treatment

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Extension study for subjects currently participating in protocols ACH443-015 and ACH443-018.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Achillion Pharmaceuticals; Alexion Pharmaceuticals
• Collaborators: Bellos, Nicholaos C., M.D.; Center for the Prevention and Treatment of Infections; Central Texas Primary Care Research Network; Orlando Immunology Center; Saint Michael
• Treatments: Dexelvucitabine; Zalcitabine

Criteria

Inclusion Criteria:

• Subject must have successfully completed 96 weeks of elvucitabine therapy in Protocol ACH443-015 OR subjects have completed 48-weeks of elvucitabine therapy in protocol ACH443-014A / 018.

Exclusion Criteria:

• Subject has experienced viroligic rebound as defined in section 5.6.1.3 of protocol ACH443-015.

• Subject has exceeded their baseline HIV-1 RNA level by Week 44 as measured in protocol ACH443-014A / 018

• Subject is experiencing a drug-related Grade 3 or 4 rash or a drug related grade 3 or 4 laboratory toxicity other than Grade 3 or 4 cholesterol, triglyceride,creatinine kinase, or LDH.