HIV Infections
Conditions
Keywords
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, curdlan sulfate
Brief summary
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.
Detailed description
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.)
Interventions
DRUGCurdlan sulfate
Sponsors
AJI Pharma USA
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed