Status:

COMPLETED

Open-Label, 48-Week Extension Study of Elvucitabine in Combination With Background Antiretroviral Therapy (ART) for Participants Who Have Completed Study ACH443-014A

Lead Sponsor:

Alexion Pharmaceuticals, Inc.

Collaborating Sponsors:

Achillion, a wholly owned subsidiary of Alexion

Conditions:

Human Immunodeficiency Virus (HIV)-1 Infection

Eligibility:

All Genders

18-60 years

Phase:

PHASE2

Brief Summary

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 me...

Detailed Description

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) ...

Eligibility Criteria

Inclusion

  • Participants who have completed 14 days of treatment in Study ACH443-014A and who, in the Investigator's judgment, remain candidates to receive elvucitabine together with background ART.

Exclusion

  • Failure to meet inclusion criteria

Key Trial Info

Start Date :

September 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2009

Estimated Enrollment :

4 Patients enrolled

Trial Details

Trial ID

NCT00380159

Start Date

September 1 2006

End Date

January 1 2009

Last Update

August 14 2023

Active Locations (7)

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Page 1 of 2 (7 locations)

1

Clinical Trial Site

Atlanta, Georgia, United States, 30308

2

Clinical Trial Site

Cincinnati, Ohio, United States, 45242

3

Clinical Trial Site

Santo Domingo, Dominican Republic

4

Clinical Trial Site

Berlin, Germany