Overview

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.