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Treatment of Advanced AIDS Patients With Dextrin Sulfate

Sponsor
Steinhart Medical Associates (Other)
Overall Status
Unknown status
CT.gov ID
NCT00004987
Collaborator
(none)
1
Location

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
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 :
Oct 1, 1999

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Steinhart Medical Associates Miami Florida United States 33133

    Sponsors and Collaborators

    • Steinhart Medical Associates

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00004987
    Other Study ID Numbers:
    • 309A
    First Posted:
    Aug 31, 2001
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Jun 1, 2001
    Keywords provided by , ,
    Anti-HIV Agents
    Viral Load
    dextrin 2-sulfate
    Infusions, Parenteral
    Additional relevant MeSH terms:
    HIV Infections

    Study Results

    No Results Posted as of Jun 24, 2005