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Continuous High-Dose Intravenous Dextran Sulfate in Human Immunodeficiency Virus-Infected Individuals
This study has been completed.
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000684
  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

MedlinePlus related topics: AIDS
Drug Information available for: Dextrans Dextran sulfate Dextran sulfate sodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Continuous High-Dose Intravenous Dextran Sulfate in Human Immunodeficiency Virus-Infected Individuals

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

Estimated Enrollment: 10
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 Blood is withdrawn 5 times on the first day that patients receive dextran sulfate and at least once a day thereafter for safety.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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000684

Locations
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Investigators
Study Chair: Lietman PS
Study Chair: Flexner CW
  More Information

Publications:
Study ID Numbers: ACTG 105
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00000684  
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes
Dextrans

Additional relevant MeSH terms:
RNA Virus Infections
Anticoagulants
Slow Virus Diseases
Immune System Diseases
Therapeutic Uses
Blood Substitutes
Hematologic Agents
Lentivirus Infections
Plasma Substitutes
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009