Treatment of Advanced AIDS Patients With Dextrin Sulfate

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2001 by NIH AIDS Clinical Trials Information Service.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00004987
First received: March 16, 2000
Last updated: June 23, 2005
Last verified: June 2001
  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 Intervention Phase
HIV Infections
Drug: Dextrin 2-sulfate
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intraperitoneal Dextrin Sulfate in Patients With Advanced HIV Disease: A Phase I Trial

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Study Start Date: October 1999
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004987

Locations
United States, Florida
Steinhart Medical Associates
Miami, Florida, United States, 33133
Sponsors and Collaborators
Steinhart Medical Associates
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004987     History of Changes
Other Study ID Numbers: 309A
Study First Received: March 16, 2000
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Anti-HIV Agents
Viral Load
dextrin 2-sulfate
Infusions, Parenteral

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 18, 2014