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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Patients are randomized to receive either lentinan (40 patients) or placebo (10 patients) in combination with ddI for at least 26 weeks; those tolerating their dose may be offered continuation of therapy for an additional 26 weeks.

Conditions

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HIV Infections

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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Lentinan

Intervention Type DRUG

Didanosine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients must have:

* HIV seropositivity.
* Absolute CD4 count of 200 - 500 cells/mm3.
* No active opportunistic infection or Kaposi's sarcoma.

Prior Medication:

Allowed:

* Prior ddI for no longer than 3 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Lymphoid malignancy.
* Pancreatitis.
* Peripheral neuropathy.
* Critical illness.

Concurrent Medication:

Excluded:

* Antiretroviral agents other than ddI.
* Steroids.
* Cytotoxic agents.
* Immunosuppressive agents.
* Immunomodulators.
* 1-Thyroxine.

Concurrent Treatment:

Excluded:

* Radiotherapy.

Prior Medication:

Excluded within 1 month prior to study entry:

* Antiretroviral agents other than ddI (patients may have received prior ddI for no longer than 3 months total).
* Steroids.
* Cytotoxic agents.
* Immunosuppressive agents.
* Immunomodulators.

Prior Treatment:

Excluded:

* Radiotherapy within 1 month prior to study entry. Active drug abuse.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Lang W

Role: STUDY_CHAIR

Goodgame J

Role: STUDY_CHAIR

Locations

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ViRx Inc

San Francisco, California, United States

Site Status

Goodgame Med Group

Maitland, Florida, United States

Site Status

Countries

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United States

References

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Gordon M, Guralnik M, Kaneko Y, Mimura T, Goodgame J, DeMarzo C, Pierce D, Baker M, Lang W. A phase II controlled study of a combination of the immune modulator, lentinan, with didanosine (ddI) in HIV patients with CD4 cells of 200-500/mm3. J Med. 1995;26(5-6):193-207.

Reference Type BACKGROUND

PMID: 8721897 (View on PubMed)

Kaneko Y, Mimura T, Guralnik M, Baker M, Goodgame J, DeMarzo C, Pierce D, Lang W, Gordon M. Phase II study of combination of lentinan with ddI in HIV-positive patients. Int Conf AIDS. 1994 Aug 7-12;10(1):212 (abstract no PB0276)