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NCT00000806 · ClinicalTrials.gov registry record · Phase 1

A Phase I Randomized Dose/Formulation Comparison Study of SC-52151

A Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
48
Enrollment target
4
Study locations

NCT00000806 is a Phase 1 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 48 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (89% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT00000806, a Phase 1 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
48 participants
Enrollment target
4
Study locations

Study Summary

PRIMARY: To evaluate the safety, tolerability, pharmacokinetics, and ethanol exposure of two dose regimens and formulations of SC-52151. SECONDARY: To evaluate the preliminary anti-HIV activity of these treatment regimens and the relationship between day 14 plasma concentrations of SC-52151 and immunological and virological markers and toxicity. Since viral isolates with decreased susceptibility to the protease inhibitor SC-52151 occur in vitro after multiple passages, and since prolonged post infectious effects occur in vitro, comparison of two formulations, an elixir and a self-emulsifying drug delivery system (SEDDS), is needed to determine the appropriate dose formulation for Phase II studies.

Conditions Studied

HIV Infections

Interventions

  • DRUG Telinavir

Study Locations (4)

California

  • Univ of California / San Diego Treatment Ctr - San Diego

Florida

  • Univ of Miami School of Medicine - Miami

Maryland

  • Johns Hopkins Hosp - Baltimore

Ohio

  • Ohio State Univ Hosp Clinic - Columbus

Trial Details

FieldValue
Enrollment Target 48 participants
Phase Phase 1

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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What the Registry Record Tells You About NCT00000806

The ClinicalTrials.gov registry entry for NCT00000806 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (89% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

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

NCT00000806 reports 4 study locations spanning 4 distinct geographic areas - top geographies include California, Florida, Maryland.

Frequently Asked Questions

What is clinical trial NCT00000806 about?

NCT00000806 is a clinical study titled "A Phase I Randomized Dose/Formulation Comparison Study of SC-52151". PRIMARY: To evaluate the safety, tolerability, pharmacokinetics, and ethanol exposure of two dose regimens and formulations of SC-52151. SECONDARY: To evaluate the preliminary anti-HIV activity of these treatment regimens and the relationship between day 14 plasma concentrations of SC-52151 and imm...

What is the current status of trial NCT00000806?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants.

What conditions does trial NCT00000806 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00000806?

The interventions under investigation include: Telinavir (DRUG).

Who is sponsoring clinical trial NCT00000806?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00000806 being conducted?

This trial has 4 study locations across California, Florida, Maryland, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.