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NCT00350272 · ClinicalTrials.gov registry record · Phase 2
Elvucitabine/Efavirenz/Tenofovir Versus Lamivudine/Efavirenz/Tenofovir in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-naive Participants
A Phase 2 study of HIV Infections, sponsored by Alexion Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
- 20
- Study locations
NCT00350272: Completed Phase 2 study of HIV Infections, sponsored by Alexion Pharmaceuticals.
NCT00350272 is a Phase 2 study of HIV Infections that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 76 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00350272, a Phase 2 study of HIV Infections, has completed, sponsored by Alexion Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 76 participants
- Enrollment target
- 20
- Study locations
Study Summary
Elvucitabine, a novel nucleoside analog, is being studied as a treatment for participants with human immunodeficiency virus (HIV)-1. This Phase 2 study will enroll 60 HIV-1-naive participants to assess the efficacy and safety of elvucitabine compared to lamivudine in combination with tenofovir and efavirenz as measured by changes in the participant's HIV-ribonucleic acid (RNA) level and CD4 cell count. The study treatment will be 12 weeks of blinded study medication followed by an additional 84 weeks of open-label treatment if the participant's response to treatment meets certain endpoints. The pharmacokinetics of elvucitabine will also be assessed during the study.
Primary Outcome
The proportion of participants having achieved a virologic response for elvucitabine 10 mg/day in combination with efavirenz and tenofovir in HIV-1-infected participants over 12 weeks compared with the proportion of participants having achieved a virologic response for lamivudine 300 mg/day in combination with efavirenz and tenofovir. Virologic response was defined as having achieved undetectable (\<50 copies/mL) HIV-1 RNA levels from baseline assessment.
Conditions Studied
Interventions
- DRUG Lamivudine
- DRUG Efavirenz
- DRUG Tenofovir
- DRUG Elvucitabine
Study Locations (20)
Florida
- Clinical Trial Site - Clearwater
- Clinical Trial Site - Fort Myers
- Clinical Trial Site - Miami
- Clinical Trial Site - Miami
- Clinical Trial Site - Orlando
- Clinical Trial Site - Tampa
- Clinical Trial Site - Tampa
- Clinical Trial Site - West Palm Beach
California
- Clinical Trial Site - Long Beach
- Clinical Trial Site - Los Angeles
Texas
- Clinical Trial Site - Austin
- Clinical Trial Site - Dallas
Arkansas
- Clinical Trial Site - Little Rock
District of Columbia
- Clinical Trial Site - Washington D.C.
Illinois
- Clinical Trial Site - Chicago
Kansas
- Clinical Trial Site - Wichita
Maryland
- Clinical Trial Site - Washington D.C
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2006-05 |
| Est. Completion | 2009-04 |
| Phase | Phase 2 |
What the finished NCT00350272 record still lists
NCT00350272 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (83% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 4 interventions - of which Lamivudine is the first listed.
NCT00350272 names 20 study sites across 11 states, led by Florida, California, Texas.
Frequently Asked Questions
What is clinical trial NCT00350272 about?
NCT00350272 is a clinical study titled "Elvucitabine/Efavirenz/Tenofovir Versus Lamivudine/Efavirenz/Tenofovir in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-naive Participants". Elvucitabine, a novel nucleoside analog, is being studied as a treatment for participants with human immunodeficiency virus (HIV)-1. This Phase 2 study will enroll 60 HIV-1-naive participants to assess the efficacy and safety of elvucitabine compared to lamivudine in combination with tenofovir and e...
What is the current status of trial NCT00350272?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2006-05. Estimated completion is 2009-04.
What conditions does trial NCT00350272 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00350272?
The interventions under investigation include: Lamivudine (DRUG), Efavirenz (DRUG), Tenofovir (DRUG), Elvucitabine (DRUG).
Who is sponsoring clinical trial NCT00350272?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00350272 being conducted?
This trial has 20 study locations across Arkansas, California, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00350272's enrollment target sits among peer trials
76 303rd of 542 higher than 238 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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