Trial | NCT00675844  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    7
Extension study for participants currently participating in Protocols ACH443-015 and ACH443-018.
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 Started
May 31
2008
Primary Completion
Mar 31
2010
Study Completion
Mar 31
2010
Last Update
Aug 14
2023

Drug Elvucitabine

10 milligrams (mg) elvucitabine daily as part of an ART regimen

Elvucitabine Experimental

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

Criteria 

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).
No Results Posted