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| Tracking Information | |
|---|---|
| First Received Date ICMJE | March 16, 2000 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | October 1999 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00004987 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Treatment of Advanced AIDS Patients With Dextrin Sulfate |
| Official Title ICMJE | Intraperitoneal Dextrin Sulfate in Patients With Advanced HIV Disease: A Phase I Trial |
| Brief Summary | 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 | 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 Phase | Phase I |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Open Label, Safety Study |
| Condition ICMJE | HIV Infections |
| Intervention ICMJE | Drug: Dextrin 2-sulfate |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Active, not recruiting |
| Enrollment ICMJE | |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria Patients may be eligible for this trial if they:
Exclusion Criteria Patients may not be eligible for this trial if they:
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| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00004987 |
| Responsible Party | |
| Study ID Numbers ICMJE | 309A |
| Study Sponsor ICMJE | Steinhart Medical Associates |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | June 2001 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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