Completed
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)
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-01
60
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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 generalized lymphadenopathy (PGL), and to determine antiviral activity at different doses of DS. 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 agent that does not have the same toxicity. DS might be a suitable drug since it has shown antiviral activity against HIV in the laboratory, and in preliminary studies it has shown little toxicity. Also, the combination of DS with AZT has been shown to be more effective than either alone.
CONDITIONS
Official Title
A Study of Dextran Sulfate in HIV-Infected Patients and in Patients With AIDS or AIDS Related Complex (ARC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 8 locations
1
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
Status Unknown
2
UCLA CARE Ctr
Los Angeles, California, United States, 90095
Status Unknown
3
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859
Status Unknown
4
George Washington Univ Med Ctr
Washington D.C., District of Columbia, United States, 20037
Status Unknown
5
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, United States, 01655
Status Unknown
6
Univ of Minnesota
Minneapolis, Minnesota, United States, 55455
Status Unknown
7
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States, 10021
Status Unknown
8
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States, 10025
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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