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NCT00312039 · ClinicalTrials.gov registry record · Phase 1
Study of Once Daily Elvucitabine Versus Lamivudine in Participants With a Documented M184V Mutation
A Phase 1 study of HIV Infections, sponsored by Alexion Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 8
- Study locations
NCT00312039: Completed Phase 1 study of HIV Infections, sponsored by Alexion Pharmaceuticals.
NCT00312039 is a Phase 1 study of HIV Infections that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 20 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (96% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00312039, a Phase 1 study of HIV Infections, has completed, sponsored by Alexion Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 8
- Study locations
Study Summary
Human immunodeficiency virus (HIV)-1 infected participants receiving long-term therapy with lamivudine or emtricitabine (nucleoside reverse transcriptase inhibitors \[NRTIs\]) are at risk for the development of a mutation at position M184 on the HIV reverse transcriptase gene. This mutation confers resistance to both drugs (\>100 fold increase in the concentration of drug producing 50% inhibition \[IC50\]). In-vitro studies with elvucitabine have shown that HIV-1 isolates with the M184V mutation show only a 10-fold increase in IC50 as compared to wild type HIV-1. Alexion Pharmaceuticals Inc. intention is to demonstrate that 10 milligrams (mg) of elvucitabine, administered once per day for 14 days with continued background anti-HIV-1 medications, will demonstrate a fall in HIV-1 ribonucleic acid (RNA) plasma levels, as compared to baseline. The data from this study will guide dosing in future long-term studies in HIV-1 infected participants with the M184V mutation.
Conditions Studied
Interventions
- DRUG Lamivudine
- DRUG Elvucitabine
Study Locations (8)
Florida
- Clinical Trial Site - Miami
- Clinical Trial Site - Orlando
- Clinical Trial Site - West Palm Beach
Alabama
- Clinical Trial Site - Birmingham
California
- Clinical Trial Site - Sacramento
Georgia
- Clinical Trial Site - Atlanta
New York
- Clinical Trial Site - New York
Ohio
- Clinical Trial Site - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2006-03-31 |
| Est. Completion | 2007-10-31 |
| Phase | Phase 1 |
What the finished NCT00312039 record still lists
NCT00312039 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (96% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Lamivudine is the first listed.
NCT00312039 lists 8 locations in 6 states (Florida, Alabama, California).
Frequently Asked Questions
What is clinical trial NCT00312039 about?
NCT00312039 is a clinical study titled "Study of Once Daily Elvucitabine Versus Lamivudine in Participants With a Documented M184V Mutation". Human immunodeficiency virus (HIV)-1 infected participants receiving long-term therapy with lamivudine or emtricitabine (nucleoside reverse transcriptase inhibitors \[NRTIs\]) are at risk for the development of a mutation at position M184 on the HIV reverse transcriptase gene. This mutation confers ...
What is the current status of trial NCT00312039?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2006-03-31. Estimated completion is 2007-10-31.
What conditions does trial NCT00312039 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00312039?
The interventions under investigation include: Lamivudine (DRUG), Elvucitabine (DRUG).
Who is sponsoring clinical trial NCT00312039?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00312039 being conducted?
This trial has 8 study locations across Alabama, California, Florida, Georgia, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00312039's enrollment target sits among peer trials
20 487th of 542 higher than 42 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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