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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.
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
Interventions
- DRUG Didanosine
- DRUG Lentinan
Study Locations (2)
California
- ViRx Inc - San Francisco
Florida
- Goodgame Med Group - Maitland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Phase | Phase 1 |
What the finished NCT00002098 record still lists
NCT00002098 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (89% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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 NCT00002098's enrollment target sits among peer trials
50 355th of 542 higher than 177 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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