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
Information provided by:
NIH AIDS Clinical Trials Information Service
First received: March 16, 2000
Last updated: June 23, 2005
Last verified: June 2001
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.
Drug: Dextrin 2-sulfate
||Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
||Intraperitoneal Dextrin Sulfate in Patients With Advanced HIV Disease: A Phase I Trial
| Study Start Date:
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004987
|Steinhart Medical Associates
|Miami, Florida, United States, 33133 |
Steinhart Medical Associates
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 16, 2000
||June 23, 2005
||United States: Food and Drug Administration
Keywords provided by NIH AIDS Clinical Trials Information Service:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 17, 2014
Acquired Immunodeficiency Syndrome
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases