An Open-Label Treatment Protocol to Provide Continued Elvucitabine Treatment

Completed · Phase 2

Conditions studied: HIV Infections

In brief

Extension study for participants currently participating in Protocols ACH443-015 and ACH443-018.

Key facts

Study ID

NCT00675844

Run by

Alexion Pharmaceuticals, Inc.

People needed

7

Starts

2008-05-01

Expected to finish

2010-03-01

Last updated by the study team

2023-08-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must have successfully completed 96 weeks of elvucitabine therapy in Protocol ACH443-015 or participants have completed 48 weeks of elvucitabine therapy in Protocol ACH443-014A-018 .

You may not qualify if…

• Participant has experienced virologic rebound as defined in Section 5.6.1.3 of Protocol ACH443-015.
• Participant has exceeded their Baseline HIV-1 RNA level by Week 44 as measured in Protocol ACH443-014A-018
• Participant 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 lactate dehydrogenase (LDH).

Where it is running

• Clinical Trial Site — Orlando, Florida, United States
• Clinical Trial Site — Pensacola, Florida, United States
• Clinical Trial Site — Newark, New Jersey, United States
• Clinical Trial Site — Austin, Texas, United States
• Clinical Trial Site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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