This trial is active, not recruiting.

Condition hiv infections
Treatment dextrin 2-sulfate
Phase phase 1
Sponsor Steinhart Medical Associates
Start date October 1999
Trial identifier NCT00004987, 309A


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Masking open label
Primary purpose treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Intraperitoneal Dextrin Sulfate in Patients With Advanced HIV Disease: A Phase I Trial
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by NIH AIDS Clinical Trials Information Service.