- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004987
Treatment of Advanced AIDS Patients With Dextrin Sulfate
June 23, 2005 updated by: Steinhart Medical Associates
Intraperitoneal Dextrin Sulfate in Patients With Advanced HIV Disease: A Phase I Trial
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.
Study Overview
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 Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Miami, Florida, United States, 33133
- Steinhart Medical Associates
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 1999
Study Registration Dates
First Submitted
March 16, 2000
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
June 1, 2001
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 309A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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