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Treatment of Advanced AIDS Patients With Dextrin Sulfate
This study is ongoing, but not recruiting participants.
Study NCT00004987   Information provided by NIH AIDS Clinical Trials Information Service
First Received: March 16, 2000   Last Updated: June 23, 2005   History of Changes

March 16, 2000
June 23, 2005
October 1999
 
 
 
Complete list of historical versions of study NCT00004987 on ClinicalTrials.gov Archive Site
 
 
 
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.

Phase I
Interventional
Treatment, Open Label, Safety Study
HIV Infections
Drug: Dextrin 2-sulfate
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004987
 
309A
Steinhart Medical Associates
 
 
NIH AIDS Clinical Trials Information Service
June 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP