Suspended
Intraperitoneal Dextrin Sulfate for Advanced HIV Disease
What is being tested
Dextrin 2-sulfate
Drug
Who is being recruted
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+9 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: October 1999
Summary
Principal SponsorSteinhart Medical Associates
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 1999
Actual date on which the first participant was enrolled.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.
Principal SponsorSteinhart Medical Associates
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections
Criteria
6 inclusion criteria required to participate
Are HIV-positive
Are able to understand and give written consent
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
Show More Criteria
3 exclusion criteria prevent from participating
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
Have been in any other study in the 6 weeks before beginning this study
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
SuspendedOne Study Center