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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)


Phase 1
12 Years
N/A
Not Enrolling
Both
HIV Infections

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Trial Information

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)


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Abrams D

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 060

NCT ID:

NCT00001009

Start Date:

Completion Date:

April 1990

Related Keywords:

  • HIV Infections
  • T-Lymphocytes
  • HIV Antigens
  • Dextran Sulfate
  • Dose-Response Relationship, Drug
  • Drug Evaluation
  • Drug Therapy, Combination
  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • AIDS-Related Complex
  • Immunologic Deficiency Syndromes

Name

Location

Mem Sloan - Kettering Cancer CtrNew York, New York  10021
Saint Luke's - Roosevelt Hosp CtrNew York, New York  10025
Los Angeles County - USC Med CtrLos Angeles, California  90033
UCLA CARE CtrLos Angeles, California  90095
San Francisco AIDS Clinic / San Francisco Gen HospSan Francisco, California  941102859
George Washington Univ Med CtrWashington, District of Columbia  20037
Univ of Massachusetts Med CtrWorcester, Massachusetts  01655
Univ of MinnesotaMinneapolis, Minnesota  55455