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

A

AJI Pharma

Status and phase

Unknown
Phase 2

Conditions

HIV Infections

Treatments

Drug: Didanosine
Drug: Lentinan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002099
92-11-9
126B

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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