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COMPLETED Phase 2

Elvucitabine/Efavirenz/Tenofovir Versus Lamivudine/Efavirenz/Tenofovir in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-naive Participants

NCT00350272 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 76 participants
Start Date 2006-05
Est. Completion 2009-04
Phase Phase 2

Sponsor

Alexion Pharmaceuticals

109 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00350272

The ClinicalTrials.gov registry entry for NCT00350272 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alexion Pharmaceuticals, which has 109 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00350272 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, California, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00350272?

The interventions under investigation include: Lamivudine (DRUG), Efavirenz (DRUG), Tenofovir (DRUG), Elvucitabine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00350272?

This trial is sponsored by Alexion Pharmaceuticals, which has 109 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial