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NCT00002098 · ClinicalTrials.gov registry record · Phase 1

Phase I/II Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients

A Phase 1 study of HIV Infections, sponsored by AJI Pharma U.

Completed
Registry status
Phase 1
Development phase
50
Enrollment target
2
Study locations

NCT00002098: Completed Phase 1 study of HIV Infections, sponsored by AJI Pharma U.

NCT00002098 is a Phase 1 study of HIV Infections that has completed, run by AJI Pharma U. The registered enrollment target is 50 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00002098, a Phase 1 study of HIV Infections, has completed, sponsored by AJI Pharma U.

COMPLETED
Registry status
Phase 1
Development phase
50 participants
Enrollment target
2
Study locations

Study Summary

To determine the tolerance and side effects of a combination of lentinan and didanosine (ddI) compared with ddI alone. To determine whether the combination of lentinan and ddI produces a significant immunorestorative effect within the study observation period (6-12 months) as measured by an increase in one or more of the following: neutrophil count and activity, T-cell subsets, and a decrease in p24 antigen.

Conditions Studied

HIV Infections

Interventions

  • DRUG Didanosine
  • DRUG Lentinan

Study Locations (2)

California

  • ViRx Inc - San Francisco

Florida

  • Goodgame Med Group - Maitland

Trial Details

FieldValue
Enrollment Target 50 participants
Phase Phase 1

Sponsor

AJI Pharma U

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00002098

The ClinicalTrials.gov registry entry for NCT00002098 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 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 AJI Pharma U, which has 2 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 Didanosine is the first listed.

NCT00002098 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Florida.

Frequently Asked Questions

What is clinical trial NCT00002098 about?

NCT00002098 is a clinical study titled "Phase I/II Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients". To determine the tolerance and side effects of a combination of lentinan and didanosine (ddI) compared with ddI alone. To determine whether the combination of lentinan and ddI produces a significant immunorestorative effect within the study observation period (6-12 months) as measured by an increase...

What is the current status of trial NCT00002098?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants.

What conditions does trial NCT00002098 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00002098?

The interventions under investigation include: Didanosine (DRUG), Lentinan (DRUG).

Who is sponsoring clinical trial NCT00002098?

This trial is sponsored by AJI Pharma U, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00002098 being conducted?

This trial has 2 study locations across California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Read our methodology - how this data is sourced, computed, and verified.
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.