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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00002099 |
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Date of registration:
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02/11/1999 |
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Primary sponsor: |
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Public title:
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Phase II/III Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients
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Scientific title:
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Phase II/III Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients |
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Date of first enrolment:
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January 1976 |
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Target sample size:
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00002099 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Pearce D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Intervention(s)
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Drug: Didanosine
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Drug: Lentinan
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Secondary ID(s)
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126B
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92-11-9
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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