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NCT00001993 · ClinicalTrials.gov registry record · Phase 2

Initial Phase II Efficacy and Safety Study of SC-48334 Administered in Combination With Low-Dose Zidovudine (AZT) to Symptomatic HIV-1 Infected Patients With = or > 200 to = or < 500 CD4+ Cells/mm3

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

Completed
Registry status
Phase 2
Development phase
120
Enrollment target
6
Study locations

NCT00001993: Completed Phase 2 study of HIV Infections, sponsored by G D Searle.

NCT00001993 is a Phase 2 study of HIV Infections that has completed, run by G D Searle. The registered enrollment target is 120 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (73% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00001993, a Phase 2 study of HIV Infections, has completed, sponsored by G D Searle.

COMPLETED
Registry status
Phase 2
Development phase
120 participants
Enrollment target
6
Study locations

Study Summary

The primary objective of this study is to determine the preliminary efficacy and tolerability of combining a selected dose of SC-48334 with low-dose AZT in the treatment of symptomatic HIV+ patients with 200 to 500 CD4+ cells/mm3. The secondary objective is to determine the pharmacokinetics and bioavailability of both SC-48334 and AZT, when administered together, in symptomatic HIV+ patients with 200 - 500 CD4+ cells/mm3.

Conditions Studied

Interventions

  • DRUG Zidovudine
  • DRUG Butyldeoxynojirimycin

Study Locations (6)

Florida

  • Univ of Miami School of Medicine - Miami

Illinois

  • Rush Presbyterian - Saint Luke's Med Ctr - Chicago

Indiana

  • Infectious Diseases Research Clinic / Indiana Univ Hosp - Indianapolis

Ohio

  • Ohio State Univ Hosp Clinic - Columbus

South Carolina

  • Julio Arroyo - West Columbia

Washington

  • Univ of Washington - Seattle

Trial Details

FieldValue
Enrollment Target 120 participants
Phase Phase 2
G D Searle

3 total trials

What the finished NCT00001993 record still lists

NCT00001993 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (73% lower).

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.

NCT00001993 lists 6 locations in 6 states (Florida, Illinois, Indiana).

Frequently Asked Questions

What is clinical trial NCT00001993 about?

NCT00001993 is a clinical study titled "Initial Phase II Efficacy and Safety Study of SC-48334 Administered in Combination With Low-Dose Zidovudine (AZT) to Symptomatic HIV-1 Infected Patients With = or > 200 to = or < 500 CD4+ Cells/mm3". The primary objective of this study is to determine the preliminary efficacy and tolerability of combining a selected dose of SC-48334 with low-dose AZT in the treatment of symptomatic HIV+ patients with 200 to 500 CD4+ cells/mm3. The secondary objective is to determine the pharmacokinetics and bio...

What is the current status of trial NCT00001993?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants.

What conditions does trial NCT00001993 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00001993?

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

Who is sponsoring clinical trial NCT00001993?

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

Where is trial NCT00001993 being conducted?

This trial has 6 study locations across Florida, Illinois, Indiana, Ohio, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for HIV Infections

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00001993's enrollment target sits among peer trials

120 239th of 542 higher than 295 of 542 other HIV Infections trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00001993, the US trial registry maintained by the National Library of Medicine. NCT00001993 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.