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)
Dextran sulfate
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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. The study will begin with 10 patients with AIDS, 10 with ARC, and 10 with asymptomatic HIV infection taking DS by mouth 3 times a day for 24 weeks. If the initial dose of DS is tolerated without significant side effects, the next group of patients will receive a higher dose. A third group of patients will be given either a higher or lower dose depending on the results of the earlier groups. Patients will be evaluated every other week for 12 weeks, then monthly for the remaining 16 weeks. Patients will have the option of continuing DS until the entire study is completed if the drug is well tolerated. Inhaled pentamidine for the prevention of Pneumocystis carinii pneumonia is allowed, but other investigational drugs are not. Drug effects on the HIV virus, immune function, and clinical condition will be monitored during the periodic evaluations.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 12 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 8 locations
Los Angeles County - USC Med Ctr
Los Angeles, United StatesOpen Los Angeles County - USC Med Ctr in Google MapsUCLA CARE Ctr
Los Angeles, United StatesSan Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, United StatesGeorge Washington Univ Med Ctr
Washington D.C., United States