A Study of Dextran Sulfate in HIV-Infected Patients and in Patients With AIDS or AIDS Related Complex (ARC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001009
First received: November 2, 1999
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Dextran sulfate
Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 60
Study Completion Date: April 1990
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 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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001009

Locations
United States, California
UCLA CARE Ctr
Los Angeles, California, United States, 90095
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859
United States, District of Columbia
George Washington Univ Med Ctr
Washington, District of Columbia, United States, 20037
United States, Massachusetts
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, United States, 01655
United States, Minnesota
Univ of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New York
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States, 10021
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States, 10025
Sponsors and Collaborators
Investigators
Study Chair: Abrams D
  More Information

Publications:
Falloon J, et al. 566C80 for the treatment of Pneumocystis carinii pneumonia in AIDS. Int Conf AIDS. 1991 Jun 16-21;7(2):241 (abstract no WB2239)
Abrams D, Pettinelli C, Power M, Kubacki VB, Grieco MH, Henry WK. A phase I/II dose ranging trial of oral dextran sulfate in HIV p24 antigen positive individuals (ACTG 060): results of a safety and efficacy trial. Int Conf AIDS. 1989 Jun 4-9;5:404 (abstract no WBP315)

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001009     History of Changes
Other Study ID Numbers: ACTG 060, 11034
Study First Received: November 2, 1999
Last Updated: March 28, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
T-Lymphocytes
HIV Antigens
Dextran Sulfate
Dose-Response Relationship, Drug
Drug Evaluation
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
AIDS-Related Complex
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Dextrans
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Plasma Substitutes
Blood Substitutes

ClinicalTrials.gov processed this record on August 21, 2014