Treatment of Advanced AIDS Patients With Dextrin Sulfate
This trial is active, not recruiting.
|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.
|Endpoint classification||safety study|
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.
|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.|
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