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Anti-viral

Lentinan + Didanosine for HIV

Phase 2

Waitlist Available

Research Sponsored by AJI Pharma USA

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No active opportunistic infection or Kaposi's sarcoma

Patients must have HIV seropositivity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing a combination of two drugs, lentinan and didanosine (ddI), to see if it is more effective and has fewer side effects than ddI alone. The study will also look at whether this combination can help the body's immune system.

Who is the study for?

This trial is for HIV-positive patients with a CD4 count of 200-500 cells/mm3, no active infections or Kaposi's sarcoma. They can have used ddI briefly before but not other antiretrovirals, steroids, cancer drugs, immune suppressors/modulators, or radiotherapy recently. Active IV drug users are excluded.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of combining lentinan with didanosine (ddI) versus using ddI alone in treating HIV. It aims to see if this combination improves immune function over 6-12 months by increasing certain white blood cell counts and decreasing viral components.See study design

What are the potential side effects?

Potential side effects may include issues related to the body's tolerance to the medications such as pancreatitis and peripheral neuropathy which were criteria for exclusion from the trial indicating their possible association with treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have any active infections or Kaposi's sarcoma.

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I am HIV positive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

AJI Pharma USALead Sponsor

2 Previous Clinical Trials

50 Total Patients Enrolled

Pearce DStudy Chair

Media Library

Didanosine (ddI) (Anti-viral) Clinical Trial Eligibility Overview. Trial Name: NCT00002099 — Phase 2

Human Immunodeficiency Virus Infection Research Study Groups:

Human Immunodeficiency Virus Infection Clinical Trial 2023: Didanosine (ddI) Highlights & Side Effects. Trial Name: NCT00002099 — Phase 2

Didanosine (ddI) (Anti-viral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00002099 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals eligible for enrollment in this research trial?

"According to the entry requirements of this medical trial, all participants must lie within an 18-60 age range. Separately, 111 trials are open for those below 18 and 363 studies have been established for senior citizens (those over 65)."

Answered by AI

Has this therapeutic intervention been officially sanctioned by the FDA?

"Currently, the safety of this treatment is rated at a 2 due to the lack of efficacy data from its Phase 2 clinical trial; however, there are some findings that support its safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Phase II/III Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00002099.

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