Treatment of Advanced AIDS Patients With Dextrin Sulfate

Steinhart Medical Associates

Status and phase: Unknown; Phase 1

Conditions: HIV Infections

Treatments: Drug: Dextrin 2-sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT00004987

309A

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.