An Open-Label Treatment Protocol to Provide Continued Elvucitabine Treatment

Study Overview
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Brief Summary
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Extension study for participants currently participating in Protocols ACH443-015 and ACH443-018.

Detailed Description
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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.

Official Title
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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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Elvucitabine


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elvucitabine<br>Participants currently receiving elvucitabine will continue elvucitabine as part of their antiretroviral therapy (ART) regimen for an additional 48 months. | Drug: Elvucitabine<br>* 10 milligrams (mg) elvucitabine daily as part of an ART regimen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination Of The Continued Efficacy Of Elvucitabine As Measured By The Change In Helper T Cell (CD4) Count. |  | 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extension study, HIV-1 infection, Treatment naive