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Home > "A" Clinical Trials Conditions > A Study of Dextran Sulfate in HIV-Infected Patients and in Patients with AIDS or AIDS Related Complex (ARC)  A Study of Dextran Sulfate in HIV-Infected Patients and in Patients with AIDS or AIDS Related Complex (ARC)
A Study of Dextran Sulfate in HIV-Infected Patients and in Patients with AIDS or AIDS Related Complex (ARC)
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 60
Location and Contact Information:
Overall Study Official:
AbramsD, Study Chair,
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: ACTG 060;
Study Start Date:
Record last reviewed: April 1990
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001009
Other Hiv Infections Studies:
1. The Safety and Effectiveness of Didanosine Plus Stavudine Plus Delavirdine Mesylate Plus MKC-442 in HIV-Infected Patients Who Have Not Had Success with Protease Inhibitors
2. Atazanavir for HIV Infected Individuals: An Early Access Program
3. A Study to Evaluate the Safety and Tolerance of Combination Anti-HIV Drug Therapy (Indinavir, Lamivudine, and Zidovudine) in HIV-Positive Pregnant Women and Their Infants
4. A Phase II, Double-Blind Trial of Recombinant Human Nerve Growth Factor for Treatment of HIV-Associated Sensory Neuropathy
5. Safety and Effectiveness of the Vaccine ALVAC-HIV vCP205 in HIV-Negative Adult Volunteers in Uganda
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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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