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NCT00002079 · ClinicalTrials.gov registry record · Phase 2

Phase II Study of the Safety and Surrogate Marker Efficacy of Butyldeoxynojirimycin (SC-48334) and AZT in Symptomatic HIV-1 Infected Patients With 200 - 500 CD4+ Cells/mm3. (NOTE: Asymptomatic HIV-1 Infected Patients Also Eligible)

A Phase 2 study of HIV Infections, sponsored by G D Searle.

Completed
Registry status
Phase 2
Development phase
9
Study locations

NCT00002079: Completed Phase 2 study of HIV Infections, sponsored by G D Searle.

NCT00002079 is a Phase 2 study of HIV Infections that has completed, run by G D Searle. The trial reports 9 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00002079, a Phase 2 study of HIV Infections, has completed, sponsored by G D Searle.

COMPLETED
Registry status
Phase 2
Development phase
9
Study locations

Study Summary

To assess the dose-related antiviral effects of SC-48334 and zidovudine (AZT) administered in combination or individually in HIV-1 positive patients with 200 - 500 CD4+ cells/mm3. To determine the safety of escalating doses of SC-48334 when administered in combination with any of three doses of AZT to symptomatic HIV-1 positive patients with 200 - 500 CD4+ cells/mm3, and to assess the pharmacokinetics of the two drugs, given separately and in combination.

Conditions Studied

Interventions

  • DRUG Zidovudine
  • DRUG Butyldeoxynojirimycin

Study Locations (9)

Texas

  • Dallas Veterans Administration Med Ctr - Dallas
  • Dr Daniel Barbero - Fort Worth
  • Park Plaza Hosp - Houston

California

  • Dr Marcus Conant - San Francisco
  • Shared Med Research Foundation - Tarzana

Florida

  • Stratogen of South Florida - Miami Beach
  • Saint Joseph's Hosp / Infectious Disease Rsch Institute - Tampa

Georgia

  • West Paces Clinical Research Incoporated - Atlanta

Pennsylvania

  • Dr Samuel W Golden - Pittsburgh

Trial Details

FieldValue
Phase Phase 2

Sponsor

G D Searle

3 total trials

What the Registry Record Tells You About NCT00002079

The ClinicalTrials.gov registry entry for NCT00002079 describes a study currently listed as completed, categorized as Phase 2. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is G D Searle, which has 3 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 Zidovudine is the first listed.

NCT00002079 reports 9 study locations spanning 5 distinct geographic areas - top geographies include Texas, California, Florida.

Frequently Asked Questions

What is clinical trial NCT00002079 about?

NCT00002079 is a clinical study titled "Phase II Study of the Safety and Surrogate Marker Efficacy of Butyldeoxynojirimycin (SC-48334) and AZT in Symptomatic HIV-1 Infected Patients With 200 - 500 CD4+ Cells/mm3. (NOTE: Asymptomatic HIV-1 Infected Patients Also Eligible)". To assess the dose-related antiviral effects of SC-48334 and zidovudine (AZT) administered in combination or individually in HIV-1 positive patients with 200 - 500 CD4+ cells/mm3. To determine the safety of escalating doses of SC-48334 when administered in combination with any of three doses of AZT ...

What is the current status of trial NCT00002079?

This trial is currently completed. It is a Phase 2 study.

What conditions does trial NCT00002079 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00002079?

The interventions under investigation include: Zidovudine (DRUG), Butyldeoxynojirimycin (DRUG).

Who is sponsoring clinical trial NCT00002079?

This trial is sponsored by G D Searle, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00002079 being conducted?

This trial has 9 study locations across California, Florida, Georgia, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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, the data changelog, or report a data error.