An Open-Label Treatment Protocol to Provide Continued Elvucitabine Treatment
1 other identifier
interventional
7
1 country
5
Brief Summary
Extension study for participants currently participating in Protocols ACH443-015 and ACH443-018.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 hiv-infections
Started May 2008
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 8, 2008
CompletedFirst Posted
Study publicly available on registry
May 12, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedAugust 14, 2023
August 1, 2023
1.8 years
May 8, 2008
August 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Determination Of The Continued Efficacy Of Elvucitabine As Measured By The Change In Helper T Cell (CD4) Count.
48 months
Study Arms (1)
Elvucitabine
EXPERIMENTALParticipants currently receiving elvucitabine will continue elvucitabine as part of their antiretroviral therapy (ART) regimen for an additional 48 months.
Interventions
Eligibility Criteria
You may qualify if:
- 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 .
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Clinical Trial Site
Orlando, Florida, 32803, United States
Clinical Trial Site
Pensacola, Florida, 32504, United States
Clinical Trial Site
Newark, New Jersey, 07102, United States
Clinical Trial Site
Austin, Texas, 78705, United States
Clinical Trial Site
Dallas, Texas, 75204, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2008
First Posted
May 12, 2008
Study Start
May 1, 2008
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
August 14, 2023
Record last verified: 2023-08