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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Page 1 of 2 (8 locations)

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