Last reviewed · How we verify
NCT00002099
Phase II/III Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients
Phase 2 trial testing Lentinan in HIV Infections. Status unknown.
Quick facts
| Lead sponsor | AJI Pharma USA |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Design | parallel |
| Primary purpose | treatment |
| Sites | 1 location 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) in comparison 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
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
The effects of orally administered Beta-glucan on innate immune responses in humans, a randomized open-label intervention pilot-study.
Leentjens J, Quintin J, Gerretsen J, Kox M, et al · · 2014 · cited 56× · PMID 25268806 · DOI 10.1371/journal.pone.0108794 -
Stimulators of immunogenic cell death for cancer therapy: focusing on natural compounds.
Amiri M, Molavi O, Sabetkam S, Jafari S, et al · · 2023 · cited 43× · PMID 37705051 · DOI 10.1186/s12935-023-03058-7 -
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:
- PubMed search for NCT00002099
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00002099 (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/NCT00002099.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing