Phase I/II Study of Curdlan Sulfate

AJI Pharma USA

Overview

To assess the safety and tolerance of curdlan sulfate, as well as its anti-HIV activity, in HIV-infected patients with CD4 T-lymphocytes less than 500 cells/mm3, using first single doses and then, after FDA review, daily doses for 7 days.

In Phase I of the study, escalating single doses of intravenous curdlan sulfate are tested. In Phase II, curdlan sulfate is administered daily for 7 days. (NOTE: Phase I is completed.)

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

HIV Infections

Interventions

Curdlan sulfateDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria Patients must have: * HIV seropositivity. * No current AIDS-defining opportunistic infection, lymphoma, Kaposi's sarcoma, or other malignancy. * CD4 count \< 500 cells/mm3. * No critical illness that would shorten life expectancy to \< 16 weeks. Exclusion Criteria Concurrent Medication: Excluded: * Antiretroviral or other experimental therapies. * Anticoagulants. * Steroids. * Cytotoxic or immunosuppressive agents. Concurrent Treatment: Excluded: * Radiotherapy. Patients with the following prior condition are excluded: History of heparin sensitivity. Prior Medication: Excluded within 1 month prior to study entry: * Antiretroviral or other experimental therapies. * Anticoagulants. * Steroids. * Cytotoxic or immunosuppressive agents. Prior Treatment: Excluded: * Radiotherapy within 1 month prior to study entry. Active IV drug abuse.

Locations (1)

ViRx Inc

San Francisco, California, United States

Data from ClinicalTrials.gov

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