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Treatment of Advanced AIDS Patients with Dextrin Sulfate - Article


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Zinc Sulfate Injection

Zinca-Pak


Clinical Trial: Treatment of Advanced AIDS Patients with Dextrin Sulfate

This study is no longer recruiting patients.

Sponsored by: Steinhart Medical Associates
Information provided by: AIDS Clinical Trials Information Service

Purpose

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 Treatment or Intervention Phase
HIV Infections
 Drug: Dextrin 2-sulfate
Phase I

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Open Label, Safety Study

Official Title: Intraperitoneal Dextrin Sulfate in Patients with Advanced HIV Disease: A Phase I Trial

Further Study Details: 

Study start: October 1999

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

Location Information


Florida
      Steinhart Medical Associates, Miami,  Florida,  33133,  United States

More Information

Study ID Numbers:  309A
Record last reviewed:  June 2001
Last Updated:  October 13, 2004
Record first received:  March 16, 2000
ClinicalTrials.gov Identifier:  NCT00004987
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 12, 2008



Page Updated: June 1, 2005
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