NCT00002098 is a Phase 1 clinical trial of Lentinan in HIV Infections, sponsored by AJI Pharma USA.

Who is sponsoring NCT00002098?

NCT00002098 is sponsored by AJI Pharma USA.

What drugs are being tested in NCT00002098?

Interventions in NCT00002098: Lentinan, Didanosine.

What condition does NCT00002098 study?

NCT00002098 studies HIV Infections.

Is NCT00002098 still recruiting?

NCT00002098 is currently completed. Last updated 23 June 2005.

Last reviewed 2005-06-23 · How we verify

NCT00002098

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 23 June 2005

What this trial tests

Phase 1 trial testing Lentinan in HIV Infections in 50 participants. Completed.

Quick facts

Lead sponsor	AJI Pharma USA
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Design	parallel
Primary purpose	treatment
Enrollment	50
Sites	2 locations across United States

Drugs / interventions tested

Lentinan (LENTINAN) — full drug profile →
Didanosine (DIDANOSINE) — full drug profile →

Conditions studied

HIV Infections — all drugs for HIV Infections →

Sponsor

AJI Pharma USA

Who can join

Adults 18 to 60, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Polysaccharide nanoparticles as potential immune adjuvants: Mechanism and function.
Jiang Y, Qi S, Mao C. · · 2025 · cited 11× · PMID 40486863 · DOI 10.1016/j.apsb.2025.03.006

Verify or expand the search:

Other recruiting trials for HIV Infections

Currently open trials in the same condition.

NCT07225530 — Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR) · NA · recruiting
NCT07202546 — A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) · Phase 2 · recruiting
NCT06694753 — Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participants Without HIV and in Overall · Phase 1 · recruiting
NCT07235852 — Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention · NA · recruiting
NCT06665646 — Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Ad · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00002098 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AJI Pharma USA
Last refreshed: 23 June 2005

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00002098.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing