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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Primary Purpose

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Lentinan

Didanosine

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Lentinan

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

HIV Research Group

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002099

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

AJI Pharma USA

1. Study Identification

Unique Protocol Identification Number

NCT00002099

Brief Title

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

Official Title

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 Type

Interventional

2. Study Status

Record Verification Date

July 1994

Overall Recruitment Status

Unknown status

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

AJI Pharma USA

4. Oversight

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Lentinan

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Lentinan

Intervention Type

Drug

Intervention Name(s)

Didanosine

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pearce D

Official's Role

Study Chair

Facility Information:

Facility Name

HIV Research Group

City

San Diego

State/Province

California

ZIP/Postal Code

92102

Country

United States

HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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