Phase I/II Study of Curdlan Sulfate

Phase I/II Study of Curdlan Sulfate

Sponsors

Lead sponsor: AJI Pharma USA

Source NIH AIDS Clinical Trials Information Service
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.)

Overall Status Completed
Phase Phase 1
Study Type Interventional
Condition
Intervention

Intervention type: Drug

Intervention name: Curdlan sulfate

Eligibility

Criteria:

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.

Gender: All

Minimum age: 18 Years

Maximum age: 60 Years

Healthy volunteers: No

Location
facility ViRx Inc
Location Countries

United States

Verification Date

April 1994

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Primary purpose: Treatment

Source: ClinicalTrials.gov