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A Placebo-Controlled Trial To Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS-Associated Kaposi's Sarcoma

Phase 3
18 Years
Not Enrolling
HIV Infections

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Trial Information

A Placebo-Controlled Trial To Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS-Associated Kaposi's Sarcoma

Patients infected with AIDS can benefit from therapy with an effective anti-AIDS virus
agent. AZT is a drug that is effective in inhibiting the effects of HIV infection. The study
will show whether toxicity of AZT can be reduced in a more manageable treatment plan, and
whether AZT therapy will delay the development of opportunistic infections and/or KS

Patients are divided into two treatment groups, the first receiving AZT for 5 doses a day,
and the second receiving AZT for 3 doses per day. A placebo group is divided into two to
match the two treatment groups. Study patients are stratified according to whether they have
(a) 10 or fewer cutaneous lesions without oral lesions or (b) more extensive cutaneous
lesions or oral lesions. Patients are seen on an outpatient basis weekly for the first 2
months, every other week for the next 2 months, and monthly thereafter.

Inclusion Criteria

Inclusion Criteria

Concurrent Medication:


- Acute treatment for mucocutaneous candidiasis, localized cutaneous herpes simplex, or
localized or disseminated zoster infections.

Concurrent Treatment:


- Blood transfusion for treatment of Grade 3 hemoglobin toxicity if the patient's
cardiovascular status is compromised or if the hemoglobin fails to show signs of
recovery following withdrawal from the study drug. Toxicity grades according to NIAID
Recommendations for Grading Acute and Subacute Toxic Effects (Adults).

Patients must have:

- HIV-related, biopsy-proven Kaposi's sarcoma mucocutaneous lesions without
constitutional symptoms.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions will be excluded:

- Symptomatic, visceral Kaposi's sarcoma.

- Lymphedema.

- HIV neurologic disease as determined by a standard neurologic examination and
neuropsychological questionnaire.

Concurrent Medication:


- Aspirin or acetaminophen on a regular basis or for longer than 72 hours without
approval of investigator.

- Cimetidine.

- Flurazepam.

- Indomethacin.

- Ranitidine.

- Probenecid.

- Drugs causing anemia, neutropenia, or significant risk of nephrotoxicity.

- Prophylaxis or chronic suppression of herpes simplex.

- Treatment of herpes simplex virus cutaneous disease more often than once a month for
5 - 7 days.

Concurrent Treatment:


- Radiation therapy for treatment of Kaposi's sarcoma lesions.

The following patients will be excluded from the study:

- Patients with a history of any AIDS-defining opportunistic infection.

- Patients with any of the following constitutional symptoms with no etiology

- Temperature more than 38 degrees and/or drenching night sweats for more than 1 month;
watery diarrhea for 2 or more weeks; weight loss of more than 10 percent.

- Patients with a history of other systemic malignancies or lymphomas.

Prior Medication:


- Systemic antineoplastic chemotherapy.

- Zidovudine (AZT).

- Excluded within 30 days of study entry:

- Antiretroviral agents.

- Immunomodulating agents.

- Prophylaxis for Pneumocystis carinii pneumonia.

- Prophylaxis for herpes simplex virus infections.

- Any other experimental therapy.

Prior Treatment:

Excluded within 30 days of study entry:

- Any experimental therapy.

- Active substance abuse.

Type of Study:


Study Design:

Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

Valentine FT

Investigator Role:

Study Chair


United States: Food and Drug Administration

Study ID:

ACTG 001



Start Date:

Completion Date:

May 1990

Related Keywords:

  • HIV Infections
  • AIDS-Related Opportunistic Infections
  • Sarcoma, Kaposi
  • Acquired Immunodeficiency Syndrome
  • Zidovudine
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Sarcoma, Kaposi
  • Sarcoma



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