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Treatment of Advanced AIDS Patients With Dextrin Sulfate

This study is ongoing, but not recruiting participants.
Study NCT00004987.   Last updated on June 23, 2005.   Information provided by NIH AIDS Clinical Trials Information Service

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Descriptive Information Fields
Brief Title  Treatment of Advanced AIDS Patients With Dextrin Sulfate
Official Title  Intraperitoneal Dextrin Sulfate in Patients With Advanced HIV Disease: A Phase I Trial
Brief Summary

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.

Detailed 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.

Study Phase Phase I
Study Type  Interventional
Study Design  Treatment, Open Label, Safety Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infections
Intervention  Drug: Dextrin 2-sulfate
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment 
Start Date  October 1999
Completion Date
Eligibility 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.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00004987
Organization ID 309A
Secondary IDs ††
Study Sponsor  Steinhart Medical Associates
Collaborators ††
Investigators 
Information Provided By NIH AIDS Clinical Trials Information Service
Verification Date June 2001
First Received Date  March 16, 2000
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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