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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 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.

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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

HIV Infections

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

FieldValue
Enrollment Target 20 participants
Start Date 2006-03-31
Est. Completion 2007-10-31
Phase Phase 1

Sponsor

Alexion Pharmaceuticals

162 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00312039

The ClinicalTrials.gov registry entry for NCT00312039 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (96% lower). The listed sponsor is Alexion Pharmaceuticals, which has 162 total studies on file at ClinicalTrials.gov.

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 reports 8 study locations spanning 6 distinct geographic areas - top geographies include 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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.