Treatment of Advanced AIDS Patients With Dextrin Sulfate

Intraperitoneal Dextrin Sulfate in Patients With Advanced HIV Disease: A Phase I Trial

The purpose of this study is to look at the safety and effectiveness of dextrin sulfate in AIDS patients who have failed conventional anti-HIV treatment.

Patients have intraperitoneal (IP) catheter placement done at study entry. Infusion with the carrier vehicle (icodextrin 4%) begins 2 weeks later, and 2 days after that, treatment with dextrin sulphate (DS) commences. DS is given three times per week. A nurse delivers initial treatments and the patient and caregiver will be trained to give subsequent treatments until DS has been given a total of 8 weeks. Patient evaluations are done regularly during treatment and observation continues for 24 weeks.

Inclusion Criteria

Patients may be eligible for this trial if they:

• Are HIV-positive.
• Have been diagnosed with AIDS and are under treatment to prevent opportunistic (AIDS-related) infection.
• Have had a CD4 cell count greater than 50 microL for at least the past 3 months.
• Have had a viral load of at least 50,000 copies/ml for at least the past 3 months.
• Have used up all other treatment options.
• Are able to understand and give written consent.

Exclusion Criteria

Patients may not be eligible for this trial if they:

• Have been in any other study in the 6 weeks before beginning this study.
• Have an active, opportunistic infection or other infection.
• Have any other long-term medical condition or nervous disorder that might make it difficult for them to finish the study.