Gentamicin Sulfate Injection |
Garamycin Injection; Jenamicin Injection; Vantage |
Clinical Trial: Treatment of Advanced AIDS Patients with Dextrin Sulfate
This study is no longer recruiting patients.
|
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 | Treatment or Intervention | Phase |
|---|---|---|
| HIV Infections | Drug: Dextrin 2-sulfate | Phase I |
MedlinePlus related topics: AIDS
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
Study start: October 1999
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 above, Genders Eligible for Study: Both
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.
Location Information
Florida
Steinhart Medical Associates, Miami, Florida, 33133, United States
More Information
Record last reviewed: June 2001
Last Updated: October 13, 2004
Record first received: March 16, 2000
ClinicalTrials.gov Identifier: NCT00004987
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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