NCT00675844

An Open-Label Treatment Protocol to Provide Continued Elvucitabine Treatment

An Open-Label Treatment Protocol to Provide Continued Elvucitabine Treatment for 48 Weeks in Participants Who Have Completed 96 Weeks of Elvucitabine Therapy in Protocol ACH443-015 or 48 Weeks of Therapy in Protocol ACH443-018

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 remain below 50 copies/milliliter (mL) at the 92-week assessment in Protocol ACH443-015 or participants who have completed 48 weeks of elvucitabine therapy and continue to maintain an HIV-1 RNA viral load below their baseline level upon entry into Protocol ACH443-018.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Elvucitabine	10 milligrams (mg) elvucitabine daily as part of an ART regimen

Timeline

• Start date: 2008-05-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2008-05-12
• Last updated: 2023-08-14

Locations

5 sites across 1 country: United States