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Treatment of Advanced AIDS Patients With Dextrin Sulfate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004987
Recruitment Status : Unknown
Verified June 2001 by NIH AIDS Clinical Trials Information Service.
Recruitment status was:  Active, not recruiting
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Dextrin 2-sulfate Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intraperitoneal Dextrin Sulfate in Patients With Advanced HIV Disease: A Phase I Trial
Study Start Date : October 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004987

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United States, Florida
Steinhart Medical Associates
Miami, Florida, United States, 33133
Sponsors and Collaborators
Steinhart Medical Associates
Layout table for additonal information Identifier: NCT00004987    
Other Study ID Numbers: 309A
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: June 2001
Keywords provided by NIH AIDS Clinical Trials Information Service:
Anti-HIV Agents
Viral Load
dextrin 2-sulfate
Infusions, Parenteral
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases