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Phase I/II Study of Curdlan Sulfate



Phase I/II Study of Curdlan Sulfate

For Condition: HIV Infections
Status: Completed
Sponsor(s): AJI Pharma USA ,
Synopsis: 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.
Details: 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.)
Eligibility:
Study Type:  Interventional, Treatment, Dose Comparison, Safety Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 

Location and Contact Information:

ViRx Inc
San Francisco,  California,  94109
United States
 


Additional Information:
Study ID Numbers:  127A;  LCPL 92-1-28
Study Start Date: 
Record last reviewed: April 1994
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002100

Other Hiv Infections Studies:
1. Treatment of AIDS and AIDS Related Complex. Part-1- Treatment of Patients With ARC (AZT vs. Placebo)

2. A Study Comparing Two Forms of Didanosine in HIV-infected Patients

3. Immune Response to Influenza Vaccine in HIV-Infected Individuals

4. The Tolerance of HIV-Infected Patients with Herpes Group Virus Infections to Oral Doses of FIAU

5. Immunologic and Virologic Consequences of Long-Term Highly Active Antiretroviral Therapy (HAART) in Subjects with Moderately Advanced HIV-1 Disease: A Follow-Up Study to ACTG 315

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