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Treatment of Advanced AIDS Patients with Dextrin Sulfate



Treatment of Advanced AIDS Patients with Dextrin Sulfate

For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Steinhart Medical Associates ,
Synopsis: 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.
Details: 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:
Study Type:  Interventional, Treatment, Open Label, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 

Location and Contact Information:

Steinhart Medical Associates
Miami,  Florida,  33133
United States
 


Additional Information:
Study ID Numbers:  309A; 
Study Start Date: October 1999
Record last reviewed: June 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004987

Other Hiv Infections Studies:
1. A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine

2. A Multicenter, Randomized, Placebo-Controlled, Double-Blinded, Phase I Trial to Evaluate the Safety and Immunogenicity of Live Recombinant Canarypox ALVAC-HIV vCP205 Combined with GM-CSF in Healthy, HIV-1 Uninfected Volunteers

3. CSP #512 - Options in Management with Anti-Retrovirals (OPTIMA)

4. Evaluation of Patients Who Have Not Had Success with Zidovudine

5. A Comparison of Zidovudine (AZT) Used Alone or in Combination with Didanosine (ddI) or Dideoxycytidine (ddC) in HIV-Infected Patients

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Other Miami Clinical Trials

Treatment of Advanced AIDS Patients with Dextrin Sulfate
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