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| Descriptive Information Fields | |
| Brief Title † | Treatment of Advanced AIDS Patients With Dextrin Sulfate |
| Official Title † | 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 † | Interventional |
| Study Design † | Treatment, Open Label, Safety Study |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | HIV Infections |
| Intervention † | Drug: Dextrin 2-sulfate |
| MEDLINE PMIDs | |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Active, not recruiting |
| Enrollment † | |
| Start Date † | October 1999 |
| Completion Date | |
| Eligibility Criteria † | Inclusion Criteria Patients may be eligible for this trial if they:
Exclusion Criteria Patients may not be eligible for this trial if they:
|
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States |
| Administrative Information Fields | |
| NCT ID † | NCT00004987 |
| Organization ID | 309A |
| Secondary IDs †† | |
| Study Sponsor † | Steinhart Medical Associates |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | June 2001 |
| First Received Date † | March 16, 2000 |
| Last Updated Date | June 23, 2005 |