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NCT00214890 · ClinicalTrials.gov registry record · Phase 2

Viral Dynamics and Pharmacokinetics of Abacavir and Tenofovir

A Phase 2 study, sponsored by University of California, San Diego.

Completed
Registry status
Phase 2
Development phase
21
Enrollment target

NCT00214890 is a Phase 2 study that has completed, run by University of California, San Diego. The registered enrollment target is 21 participants.

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The verdict

NCT00214890, a Phase 2 study, has completed, sponsored by University of California, San Diego.

COMPLETED
Registry status
Phase 2
Development phase
21 participants
Enrollment target

Study Summary

Once-daily nucleotide/nucleoside reverse transcriptase inhibitor (NtRTI/NRTI) combinations form the backbone of many regimens. Although efficacy data exists between tenofovir and the pyrimidine analogues (i.e. lamivudine and emtricitabine), recent clinical data suggests a potential interaction between tenofovir and purine analogs (i.e. abacavir and didanosine). Specific Aim 1: To evaluate the impact of an acyclic nucleoside phosphonate, tenofovir (TDF), on the intracellular metabolism of a purine nucleoside analog, abacavir (ABC), as a determinant of the antiviral potency of this nucleotide/nucleoside reverse transcriptase inhibitor (NtRTI/NRTI) combination. * Hypothesis #1: ABC and TDF dosed together will have reduced antiviral activity, as measured by early plasma HIV RNA decay kinetics, than the drugs given alone. * Hypothesis #2: ABC dosed with TDF will have reduced intracellular concentrations, as measured by the ratio of carbovir triphosphate (active metabolite of ABC) to deoxyguanosine triphosphate (endogenous nucleotide), compared to ABC given alone.

Interventions

  • DRUG Abacavir
  • DRUG Tenofovir

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2004-12-07
Est. Completion 2010-04-27
Phase Phase 2

Sponsor

University of California, San Diego

775 total trials

What the Registry Record Tells You About NCT00214890

The ClinicalTrials.gov registry entry for NCT00214890 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Abacavir is the first listed.

NCT00214890 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00214890 about?

NCT00214890 is a clinical study titled "Viral Dynamics and Pharmacokinetics of Abacavir and Tenofovir". Once-daily nucleotide/nucleoside reverse transcriptase inhibitor (NtRTI/NRTI) combinations form the backbone of many regimens. Although efficacy data exists between tenofovir and the pyrimidine analogues (i.e. lamivudine and emtricitabine), recent clinical data suggests a potential interaction betwe...

What is the current status of trial NCT00214890?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2004-12-07. Estimated completion is 2010-04-27.

What interventions are being tested in trial NCT00214890?

The interventions under investigation include: Abacavir (DRUG), Tenofovir (DRUG).

Who is sponsoring clinical trial NCT00214890?

This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.

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

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.