Treatment of Advanced AIDS Patients With Dextrin Sulfate - Full Text View

Treatment of Advanced AIDS Patients With Dextrin Sulfate

This study is ongoing, but not recruiting participants.

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

ChemIDplus related topics:

Caloreen Dextrin 2-sulfate

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

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

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Lentivirus Infections

Infection

ClinicalTrials.gov processed this record on August 28, 2008