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Treatment of Advanced AIDS Patients With Dextrin Sulfate

Intraperitoneal Dextrin Sulfate in Patients With Advanced HIV Disease: A Phase I Trial

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00004987
Enrollment
Unknown
Registered
2001-08-31
Start date
1999-10-31
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Anti-HIV Agents, Viral Load, dextrin 2-sulfate, Infusions, Parenteral

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.

Interventions

DRUGDextrin 2-sulfate

Sponsors

Steinhart Medical Associates
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026