Status:
COMPLETED
An Open-Label Treatment Protocol to Provide Continued Elvucitabine Treatment
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Collaborating Sponsors:
Achillion, a wholly owned subsidiary of Alexion
Conditions:
HIV Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Extension study for participants currently participating in Protocols ACH443-015 and ACH443-018.
Detailed Description
Human immunodeficiency virus (HIV)-1-infected, clinically stable, treatment-naïve adult participants who have completed 96 weeks of elvucitabine therapy and whose HIV ribonucleic acid (RNA) levels rem...
Eligibility Criteria
Inclusion
- • 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 .
Exclusion
- 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).
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00675844
Start Date
May 1 2008
End Date
March 1 2010
Last Update
August 14 2023
Active Locations (5)
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1
Clinical Trial Site
Orlando, Florida, United States, 32803
2
Clinical Trial Site
Pensacola, Florida, United States, 32504
3
Clinical Trial Site
Newark, New Jersey, United States, 07102
4
Clinical Trial Site
Austin, Texas, United States, 78705