Treatment of Advanced AIDS Patients With Dextrin Sulfate

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Primary Purpose

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Dextrin 2-sulfate

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Anti-HIV Agents, Viral Load, dextrin 2-sulfate, Infusions, Parenteral

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Steinhart Medical Associates

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004987

First Posted

March 16, 2000

Last Updated

June 23, 2005

Sponsor

Steinhart Medical Associates

1. Study Identification

Unique Protocol Identification Number

NCT00004987

Brief Title

Treatment of Advanced AIDS Patients With Dextrin Sulfate

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2001

Overall Recruitment Status

Unknown status

Study Start Date

October 1999 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Steinhart Medical Associates

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Masking

None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Dextrin 2-sulfate

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Facility Information:

Facility Name

Steinhart Medical Associates

City

Miami

State/Province

Florida

ZIP/Postal Code

33133

Country

United States

HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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