Phase I/II Study of Curdlan Sulfate
Completed · Phase 1
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002100
- Run by
- AJI Pharma USA
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- ViRx Inc — San Francisco, California, United States
Full record on ClinicalTrials.gov
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