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Treatment of Advanced AIDS Patients With Dextrin Sulfate

NCT ID: NCT00004987

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

1999-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections

Keywords

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Anti-HIV Agents Viral Load dextrin 2-sulfate Infusions, Parenteral

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Dextrin 2-sulfate

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Steinhart Medical Associates

OTHER

Sponsor Role lead

Locations

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Steinhart Medical Associates

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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309A

Identifier Type: -

Identifier Source: org_study_id