An Open-Label Treatment Protocol to Provide Continued Elvucitabine Treatment

Alexion Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: HIV Infections

Treatments: Drug: Elvucitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00675844

ACH443-904

Details and patient eligibility

About

Extension study for participants currently participating in Protocols ACH443-015 and ACH443-018.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Elvucitabine

Experimental group

Description:

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

Treatment:

Drug: Elvucitabine