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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00001009 |
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Date of registration:
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02/11/1999 |
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Primary sponsor: |
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Public title:
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A Study of Dextran Sulfate in HIV-Infected Patients and in Patients With AIDS or AIDS Related Complex (ARC)
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Scientific title:
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A Phase I/II Dose Ranging Trial of Oral Dextran Sulfate (UA001) in HIV Infected Individuals and in Patients With Acquired Immunodeficiency Syndrome (AIDS) or AIDS Related Complex (ARC) |
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Date of first enrolment:
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November 1999 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00001009 |
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Study type:
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Interventional |
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Study design:
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Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Abrams D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria
Concurrent Medication:
Allowed:
- Aerosolized pentamidine for prophylaxis of Pneumocystis carinii pneumonia (PCP).
- Acetaminophen.
- Ketoconazole.
Consistently positive serum HIV p24 antigen = or > 70 picograms/ml, defined by the Abbott
HIV antigen test, on two occasions, each within 1 month prior to entry, separated by at
least 72 hours, the last of which must be within 2 weeks of starting therapy. Positive
antibody to HIV with a federally licensed ELISA test kit.
Exclusion Criteria
Patients with any negative HIV p24 antigen test within 1 month of entry are excluded.
Hemophiliacs are excluded.
Prior Medication:
Excluded within 4 weeks of study entry:
- Biologic response modifiers.
- Zidovudine (AZT) or other antiretroviral agents.
- Other investigational drugs.
- Excluded within 12 weeks of study entry:
- Ribavirin.
- Excluded:
- Ongoing therapy and/or prophylaxis for an AIDS-defining opportunistic infection.
- Anticoagulant drugs.
- Systemic corticosteroids.
- Aspirin.
- Dextran sulfate.
- Sedatives.
- Barbiturates.
Prior Treatment:
Excluded within 2 weeks of study entry:
- Transfusion.
Severe diarrhea:
- = or > 5 loose or watery stools per day. Significant malabsorption:
- > 10 percent weight loss within past 3 months with serum carotene < 75 IU/ml or
vitamin A < 75 IU/ml. Transfusion dependent:
- Requiring 2 units of blood > once a month. Active opportunistic infection.
Symptomatic visceral Kaposi's sarcoma (KS), progression of KS within 1 month of
entry, or concurrent neoplasms other than KS. Basal cell carcinoma of the skin or in
situ carcinoma of the cervix. Hemorrhagic diseases such as hemophilia A or B or von
Willebrand disease.
Active drug or alcohol abuse sufficient in the investigator's opinion to prevent adequate
compliance with study therapy.
Age minimum:
12 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Intervention(s)
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Drug: Dextran sulfate
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Secondary ID(s)
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11034
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ACTG 060
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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