Treatment of Advanced AIDS Patients With Dextrin Sulfate

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00004987
• Other study ID #: 309A
• Status: Active, not recruiting
• Phase: Phase 1
• First received: March 16, 2000
• Last updated: June 23, 2005
• Start date: October 1999

Study information

• Verified date: June 2001
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Dextrin 2-sulfate

Locations

Country	Name	City	State
United States	Steinhart Medical Associates	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Steinhart Medical Associates

Country where clinical trial is conducted

United States,