A Multicenter Placebo-Controlled Double-Blind Trial to Evaluate Azidothymidine (AZT) Treatment of the AIDS Dementia Complex and Central Nervous System (CNS) Human Immunodeficiency Virus (HIV) Infection
12 Years
N/A
Both
AIDS Dementia Complex, HIV Infections
Trial Information
A Multicenter Placebo-Controlled Double-Blind Trial to Evaluate Azidothymidine (AZT) Treatment of the AIDS Dementia Complex and Central Nervous System (CNS) Human Immunodeficiency Virus (HIV) Infection
HIV infection can result in impairment in the function of the brain and spinal cord, leading
to disturbances in the ability to think clearly and in strength and coordination. This
disorder, which has been called the AIDS dementia complex, may be due to a direct effect of
HIV on the nervous system. It is known that AZT does get into the brain to some extent,
where it may reduce growth of HIV. It is hoped that AZT will stabilize or improve the
symptoms of the AIDS dementia complex.
The study is done in 2 stages. In Stage 1, patients are randomized to receive placebo or 1
of 2 doses of AZT. Stage 1 lasts for 4 months. In Stage 2, patients who were initially
treated with placebo are randomized again and all patients receive AZT. Stage 2 lasts an
additional 12 months, during which time there are periodic medical and neurologic
evaluations. Before beginning treatment, all patients have a lumbar puncture and a
computerized tomographic (CT) scan of the brain. The lumbar puncture is repeated twice
during and once at the end of Stage 1; the CT scan is also repeated at the end of Stage 1.
Patients receiving AZT in either stage 1 or Stage 2 are seen by their physicians every week
for the first 4 weeks and every other week thereafter for the first 4 months of receiving
the drug. After 4 months, patients are seen by their physicians at 4 to 12 week intervals.
Inclusion Criteria
Inclusion Criteria
Concurrent Medication:
Allowed:
- Aspirin, in modest doses.
- Ibuprofen, in modest doses.
- Maintenance antibiotic therapy posttherapy for an AIDS-defining opportunistic
infection.
Concurrent Treatment:
Allowed:
- Blood transfusion if cardiovascular status is compromised.
Exclusion Criteria
- Active substance abuse.
Co-existing Condition:
Patients with the following conditions will be excluded:
- Concurrent or previous central nervous system infections or neoplasms.
- Active AIDS-defining opportunistic infection.
- Severe premorbid psychiatric illness.
- Confounding neurological disease.
- Concurrent neoplasms.
Concurrent Medication:
Excluded:
- Maintenance methadone or naltrexone.
- Acetaminophen.
- Mood- or central nervous system-altering drugs.
- Zidovudine for Pneumocystis carinii pneumonia (PCP).
- Acyclovir.
- Rifampin or derivatives.
- Drugs with antiretroviral activity.
- Experimental agents.
The following patients will be excluded from the study:
- Patients requiring ongoing therapy for an AIDS-defining opportunistic infection.
- Patients with a history of Mycobacterium avium intracellulare infection.
- Patients with a history of Pneumocystis carinii pneumonia infection.
- Patients with a daily temperature of 38 degrees C or more for 1 month.
Prior Medication:
Excluded:
- Zidovudine (AZT).
- Excluded within 14 days of study entry:
- Systemic anti-infectives.
- Excluded within 30 days of study entry:
- Immunomodulators and biologic response modifiers.
- Any investigational agent.
- Cytotoxic chemotherapy for Kaposi's sarcoma.
Prior Treatment:
Excluded:
- Radiation therapy.
Patients must demonstrate the following clinical and laboratory findings:
- No currently active AIDS-defining opportunistic infections.
- One negative blood culture for Mycobacterium avium intracellulare within 4-6 weeks
prior to study entry.
- Constitutionally well without persistent fever.
- Less than 25 Kaposi's sarcoma lesions and less than 10 new lesions during the 30 days
prior to study entry. Patients may have stable or indolently progressive
mucocutaneous Kaposi's sarcoma.
- Characteristic clinical symptoms and signs of AIDS dementia complex.
- Abnormalities on 2 or more of 7 neuropsychological motor tests in the Neurological
Screening Battery.
- Estimated premorbid IQ equal to or greater than 70 (+ or - 5), which is consistent
with completion of sixth grade.
Type of Study:
Interventional
Study Design:
Masking: Double-Blind, Primary Purpose: Treatment
Principal Investigator
R Price
Investigator Role:
Study Chair
Authority:
United States: Food and Drug Administration
Study ID:
ACTG 005
NCT ID:
NCT00000702
Start Date:
Completion Date:
August 1990
Related Keywords:
- AIDS Dementia Complex
- HIV Infections
- AIDS Dementia Complex
- Zidovudine
- Acquired Immunodeficiency Syndrome
- HIV Infections
- AIDS Dementia Complex
- Dementia
- Immunologic Deficiency Syndromes
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 |
| Julio Arroyo | West Columbia, South Carolina 29169 |
| UCLA CARE Ctr | Los Angeles, California 90095 |
| Univ of California / San Diego Treatment Ctr | San Diego, California 921036325 |
| Stanford Univ School of Medicine | Stanford, California 94305 |
| Univ of Miami School of Medicine | Miami, Florida 331361013 |
| 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 |
| Beth Israel Deaconess Med Ctr | Boston, Massachusetts 02215 |
| Bronx Municipal Hosp Ctr/Jacobi Med Ctr | Bronx, New York 10461 |
| Jack Weiler Hosp / Bronx Municipal Hosp | Bronx, New York 10465 |
| 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 |
| Univ of Washington | Seattle, Washington 98105 |
| Johns Hopkins Hosp | Baltimore, Maryland 21287 |
| Charity Hosp / Tulane Univ Med School | New Orleans, Louisiana 70112 |
