Phase II/III 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

UNKNOWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Patients are treated with daily oral ddI for 6 weeks, then are randomized to ddI in combination with intravenous lentinan or placebo (administered once weekly) for 26 weeks. Patients who are already stabilized on 400 mg/day ddI will proceed directly to randomization. Following completion of the combination therapy, patients may be offered 26 additional weeks of therapy on an optional basis.

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 IV 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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Pearce D

Role: STUDY_CHAIR

Locations

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HIV Research Group

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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92-11-9

Identifier Type: -

Identifier Source: secondary_id

126B