An Open-Label Treatment Protocol to Provide Continued Elvucitabine Treatment

Phase 2

Completed

• Conditions: HIV Infections
• Interventions: Drug: Elvucitabine

• Registration Number: NCT00675844
• Lead Sponsor: Alexion Pharmaceuticals, Inc.

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 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.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-08
• Study First Submitted QC: 2008-05-09
• Study First Posted: 2008-05-12
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Disposition First Submitted: 2014-01-20
• Disposition First Submitted QC: 2014-01-20
• Disposition First Posted: 2014-02-13
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• 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 Criteria

• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Elvucitabine	Elvucitabine	Participants currently receiving elvucitabine will continue elvucitabine as part of their antiretroviral therapy (ART) regimen for an additional 48 months.

Primary Outcome Measures

Name	Time	Method
Determine Safety Profile Of Elvucitabine Measured By Incidence Of Study Discontinuations And Incidence, Severity, And Type Of Adverse Events And Clinically Significant Changes Or Abnormalities In Participant's Clinical Laboratory Results.	48 months

Secondary Outcome Measures

Name	Time	Method
Determination Of The Continued Efficacy Of Elvucitabine As Measured By The Change In Helper T Cell (CD4) Count.	48 months

Trial Locations

Locations (1)

Clinical Trial Site; 🇺🇸 Dallas, Texas, United States