NCT00380159

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

An Open-Label, 48-Week Extension Study of Elvucitabine Administered In Combination With Background Antiretroviral Agents in Participants Who Have Completed 14 Days of Treatment in Protocol ACH443-014A.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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 meet the inclusion and exclusion criteria.

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) will begin on Day 1 (Day 15 following completion of Study ACH443-014A) for all consenting participants in combination with background ART as determined by the Principal Investigator. Participants will have clinical and laboratory assessments every 2 weeks for the first 8 weeks and then every 4 weeks to Week 48.

Conditions

• Human Immunodeficiency Virus (HIV)-1 Infection

Interventions

Type	Name	Description
DRUG	Elvucitabine	Elvucitabine 10 mg in combination with background ART
DRUG	Lamivudine
DRUG	Emtricitabine

Timeline

• Start date: 2006-09-01
• Primary completion: 2008-12-01
• Completion: 2009-01-01
• First posted: 2006-09-25
• Last updated: 2023-08-14

Locations

7 sites across 4 countries: United States, Dominican Republic, Germany, Spain