Status:
COMPLETED
A Study of Dextran Sulfate in HIV-Infected Patients and in Patients With AIDS or AIDS Related Complex (ARC)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
12+ years
Phase:
PHASE1
Brief Summary
To determine the effectiveness and safety of dextran sulfate (DS) as a treatment for patients with AIDS, AIDS related complex (ARC), or asymptomatic HIV infection with or without persistent generalize...
Detailed Description
Although zidovudine (AZT) has shown promise in prolonging life in patients with AIDS and severe ARC, it has significant blood toxicities. It would be beneficial to combine AZT with another antiviral a...
Eligibility Criteria
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
April 1 1990
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00001009
End Date
April 1 1990
Last Update
November 1 2021
Active Locations (8)
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1
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
2
UCLA CARE Ctr
Los Angeles, California, United States, 90095
3
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859
4
George Washington Univ Med Ctr
Washington D.C., District of Columbia, United States, 20037