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Continuous High-Dose Intravenous Dextran Sulfate in Human Immunodeficiency Virus-Infected Individuals

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000684
First Posted: August 31, 2001
Last Update Posted: March 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose

To determine the safety and effectiveness of dextran sulfate when it is administered intravenously at the maximum tolerated dose (MTD) as a treatment for HIV infection in AIDS patients. The effect of dextran sulfate on platelet survival will also be assessed in 3 patients to help determine the mechanism of thrombocytopenia (low platelets) noted in all patients receiving intravenous dextran sulfate in this study.

Dextran sulfate appears to inhibit HIV in experiments in the test tube, but studies conducted in humans to determine its effect on HIV when dextran sulfate is given orally have not been conclusive. It is hoped that this study will show that dextran sulfate administered intravenously


Condition Intervention
HIV Infections Drug: Dextran sulfate

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Continuous High-Dose Intravenous Dextran Sulfate in Human Immunodeficiency Virus-Infected Individuals

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 10
Study Completion Date: April 1991
Detailed Description:

Dextran sulfate appears to inhibit HIV in experiments in the test tube, but studies conducted in humans to determine its effect on HIV when dextran sulfate is given orally have not been conclusive. It is hoped that this study will show that dextran sulfate administered intravenously will have antiviral effects in patients who are infected with HIV.

Following tests for evaluation, patients are hospitalized for 14 days. They are admitted to the hospital in the afternoon and, starting the next morning, receive a continuous infusion of dextran sulfate through an intravenous line for 14 days. The infusion is adjusted to maintain an activated partial thromboplastin time (APTT) of 50 to 65 seconds. Blood is withdrawn 5 times on the first day that patients receive dextran sulfate and at least once a day thereafter for safety. Patients' clinical condition, blood clotting, and blood platelets are monitored very closely.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Acetaminophen.

Patients must have:

Clinically documented AIDS or AIDS-related complex (ARC) defined as CDC group IVA or history of any of the findings that define CDC group IV subgroup C-2:

  • oral candidiasis, oral hairy leukoplakia, multidermatomal herpes zoster, recurrent nontyphoidal Salmonella bacteremia, or nocardiosis.

Prior Medication:

Allowed:

  • Acetaminophen.

Exclusion Criteria

Concurrent Treatment:

Excluded:

  • Intramuscular injections.

Patients will be excluded from the study for the following reasons:

  • Acute illness requiring hospitalization or antiviral drug therapy for treatment.
  • Volunteers who have taken any antiviral medications, anticoagulants, antiplatelet medications, or any nonsteroidal anti-inflammatory drugs, except acetaminophen, within 2 weeks of study entry, or those who anticipate the need for such medication during the study.
  • Positive stool guaiac at screening.
  • Disorders of coagulation or any known contraindication to anticoagulation, including but not limited to gastrointestinal or other serious bleeding, major trauma or surgery within the past 2 months, stroke or suspicion of central nervous system (CNS) bleeding, Kaposi sarcoma (with or without proven gastrointestinal involvement), and any known CNS lesions that might be prone to bleed.
  • Allergy to dextran sulfate or heparin.
  • Acute or asymptomatic HIV infection.

Prior Medication:

Excluded:

  • Antiviral medications.
  • Anticoagulants.
  • Antiplatelet medications.
  • Any nonsteroidal anti-inflammatory drugs (except acetaminophen).

Prior Treatment:

Excluded:

  • Hospitalization for acute illness.

Patients may not have any of the following diseases or symptoms:

  • Allergy to dextran sulfate or heparin.
  • Acute or asymptomatic HIV infection.
  • Acute illness requiring hospitalization.
  • Chronic anemia requiring transfusion within the past month.
  • Disorders of coagulation or any known contraindication to anticoagulation, including but not limited to gastrointestinal or other serious bleeding, major trauma or surgery within the past 2 months, stroke or suspicion of central nervous system (CNS) bleeding, Kaposi's sarcoma, and any known CNS lesions which might be prone to bleed.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000684


Locations
United States, Maryland
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: Lietman PS
Study Chair: Flexner CW
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000684     History of Changes
Other Study ID Numbers: ACTG 105
11080 ( Registry Identifier: DAIDS ES Registry Number )
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: March 17, 2014
Last Verified: March 2012

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Infusions, Intravenous
Dextran Sulfate
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Dextrans
Anticoagulants
Plasma Substitutes
Blood Substitutes