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NCT00002254 · ClinicalTrials.gov registry record · NA

A Multi-Center, Open-Label, Ascending, Multiple Oral Dose, Safety, Tolerance and Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Patients With Acquired Immune Deficiency Syndrome (AIDS) or AIDS-Related Complex (ARC)

A NA study of HIV Infections, sponsored by Lederle Laboratories.

Completed
Registry status
NA
Development phase
3
Study locations

NCT00002254: Completed NA study of HIV Infections, sponsored by Lederle Laboratories.

NCT00002254 is a NA study of HIV Infections that has completed, run by Lederle Laboratories. The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00002254, a NA study of HIV Infections, has completed, sponsored by Lederle Laboratories.

COMPLETED
Registry status
NA
Development phase
3
Study locations

Study Summary

To assess the tolerance and toxicity profile of deoxy-3'-fluorothymidine (FLT) after multiple oral dosing for 16 weeks. To characterize the steady-state pharmacokinetics of FLT after multiple oral doses. To assess the effect of FLT on immunologic and virologic markers of HIV infection (CD4+ lymphocyte count, p24 antigen, viremia) in patients with AIDS or AIDS related complex (ARC) after multiple oral dosing for 16 weeks.

Conditions Studied

HIV Infections

Interventions

  • DRUG Alovudine

Study Locations (3)

Maryland

  • Johns Hopkins Hosp - Baltimore

New York

  • Mem Sloan - Kettering Cancer Ctr - New York

North Carolina

  • Univ of North Carolina School of Medicine - Chapel Hill

Trial Details

FieldValue
Phase NA
Lederle Laboratories

6 total trials

What the finished NCT00002254 record still lists

NCT00002254 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.

The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which Alovudine is the first listed.

NCT00002254 reports a single indexed study location in Maryland, New York, North Carolina.

Frequently Asked Questions

What is clinical trial NCT00002254 about?

NCT00002254 is a clinical study titled "A Multi-Center, Open-Label, Ascending, Multiple Oral Dose, Safety, Tolerance and Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Patients With Acquired Immune Deficiency Syndrome (AIDS) or AIDS-Related Complex (ARC)". To assess the tolerance and toxicity profile of deoxy-3'-fluorothymidine (FLT) after multiple oral dosing for 16 weeks. To characterize the steady-state pharmacokinetics of FLT after multiple oral doses. To assess the effect of FLT on immunologic and virologic markers of HIV infection (CD4+ lymphocy...

What is the current status of trial NCT00002254?

This trial is currently completed. It is a NA study.

What conditions does trial NCT00002254 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00002254?

The interventions under investigation include: Alovudine (DRUG).

Who is sponsoring clinical trial NCT00002254?

This trial is sponsored by Lederle Laboratories, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00002254 being conducted?

This trial has 3 study locations across Maryland, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT00002254, the US trial registry maintained by the National Library of Medicine. NCT00002254 (unsized enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.