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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

HIV Infections

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
G D Searle

3 total trials

What the finished NCT00002079 record still lists

NCT00002079 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 2 interventions - of which Zidovudine is the first listed.

NCT00002079 lists 9 locations in 5 states (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.

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Related registry views

Source: ClinicalTrials.gov NCT00002079, the US trial registry maintained by the National Library of Medicine. NCT00002079 (unsized enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.