Treatment of Advanced AIDS Patients With Dextrin Sulfate

This study is ongoing, but not recruiting participants.

First Received: March 16, 2000 Last Updated: June 23, 2005 History of Changes

Sponsored by:	Steinhart Medical Associates
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00004987

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 I

MedlinePlus related topics: AIDS

Drug Information available for: Dextrin 2-sulfate Caloreen

U.S. FDA Resources

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 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

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

Study ID Numbers:	309A
Study First Received:	March 16, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004987 History of Changes
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

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on May 07, 2009