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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
N/A
Not Enrolling
Male
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
lesions.

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:

Allowed:

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

Concurrent Treatment:

Allowed:

- 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:

Excluded:

- 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:

Excluded:

- 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
established:

- 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:

Excluded:

- 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:

Interventional

Study Design:

Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

Valentine FT

Investigator Role:

Study Chair

Authority:

United States: Food and Drug Administration

Study ID:

ACTG 001

NCT ID:

NCT00000994

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

Name

Location

Bellevue Hosp / New York Univ Med Ctr New York, New York  10016
Mem Sloan - Kettering Cancer Ctr New York, New York  10021
Univ of Rochester Medical Center Rochester, New York  14642
Los Angeles County - USC Med Ctr Los Angeles, California  90033
UCLA CARE Ctr Los Angeles, California  90095
Univ of California / San Diego Treatment Ctr San Diego, California  921036325
San Francisco AIDS Clinic / San Francisco Gen Hosp San Francisco, California  941102859
Stanford at Kaiser / Kaiser Permanente Med Ctr San Francisco, California  94115
Stanford Univ School of Medicine Stanford, California  94305
Louisiana State Univ Med Ctr / Tulane Med School New Orleans, Louisiana  70112
Tulane Univ School of Medicine New Orleans, Louisiana  70112
Harvard (Massachusetts Gen Hosp) Boston, Massachusetts  02114
Univ of Minnesota Minneapolis, Minnesota  55455
Bronx Veterans Administration / Mount Sinai Hosp Bronx, New York  10468
SUNY / Erie County Med Ctr at Buffalo Buffalo, New York  14215
City Hosp Ctr at Elmhurst / Mount Sinai Hosp Elmhurst, New York  11373
Mount Sinai Med Ctr New York, New York  10029
Beth Israel Med Ctr / Peter Krueger Clinic New York, New York  10003
SUNY / State Univ of New York Syracuse, New York  13210
Duke Univ Med Ctr Durham, North Carolina  27710
Johns Hopkins Hosp Baltimore, Maryland  21287
Charity Hosp / Tulane Univ Med School New Orleans, Louisiana  70112