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An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts


Phase 3
12 Years
N/A
Not Enrolling
Both
AIDS Dementia Complex, HIV Infections

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Trial Information

An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts


Individuals with AIDS frequently suffer central nervous system (CNS) problems that are
characterized by cognitive, motor, and behavioral deficits, in a disorder known as AIDS
dementia complex. Clinical experience suggests that its course is often progressive, going
from initial symptoms to moderate or severe dementia within several months. Accumulating
evidence now suggests that direct brain infection by the HIV virus is the likely cause of
the AIDS dementia complex. Case reports suggest that therapy with AZT, which has been shown
to be a strong inhibitor of HIV replication in vitro, may alleviate the AIDS dementia
complex. This study will help define the natural history of the AIDS dementia complex in
treated patients.

All patients receive AZT for 24 weeks. Patients are seen weekly for the first 4 weeks, every
other week for the next 8 weeks, and then every 4 weeks until the completion of the study
for neuropsychological evaluation. This evaluation includes lumbar puncture, and either
computerized tomography or magnetic resonance imaging.

Inclusion Criteria


Inclusion Criteria

Concurrent Medication:

Allowed:

- Prophylactic therapy for Pneumocystis carinii pneumonia (PCP); aerosol pentamidine is
the preferred method.

- Maintenance anticonvulsant therapy following a seizure in the context of the AIDS
dementia complex.

- Patients taking anticonvulsants should have their anticonvulsant blood levels
measured prior to starting zidovudine (AZT) or with changes in AZT dosage.

- Phenytoin, carbamazepine, and valproic acid.

- Judicious use of benzodiazepams.

- For analgesia or fever, modest doses of aspirin, Tylenol, or ibuprofen.

- Use of major mood or central nervous system altering drugs is discouraged and should
be documented.

Patients with the following are included:

- An estimated pre-illness IQ = or > 70.

- A general neurodiagnostic evaluation before entry which will include a computerized
tomographic (CT) scan or magnetic resonance imaging (MRI) scan and a lumbar puncture.

- Stable or indolently progressive mucocutaneous Kaposi's sarcoma with < 25 lesions and
onset of < 10 new lesions during the 30-day period prior to study entry.

- Chronic seizure disorders requiring anticonvulsant therapy as long as the seizures
are not associated with a fixed neurologic deficit.

- A blood HIV culture and p24 antigen capture assay at the time of the lumbar
puncture. A second p24 antigen assay on study entry. Informed consent form must be
signed by the patient, legal guardian, or parent.

Active substance abuse that would limit a patient's cooperation or evaluation.

Exclusion Criteria

Co-existing Condition:

Patients with the following will be excluded from the study:

- Active, symptomatic AIDS-associated opportunistic infections requiring ongoing
maintenance therapy.

- Persistent fever, active persistent diarrhea, or continued severe weight loss.

- Severe premorbid psychiatric illness.

- Confounding neurologic disease or deficit.

- Concurrent or previous central nervous system infections or neoplasms.

- Concurrent active neoplasms other than basal cell carcinoma of the skin and
mucocutaneous Kaposi's sarcoma.

Concurrent Medication:

Excluded:

- Major psychotropic medication including tricyclic antidepressants, MAO inhibitors,
phenothiazines, butyrophenones, barbiturates, or amphetamines.

- Cimetidine.

- Ranitidine.

- Probenecid.

- Indomethacin.

- Acyclovir (ACV) prophylaxis for recurrent Herpes simplex.

Patients with the following will be excluded from the study:

- Active, symptomatic AIDS-associated opportunistic infections requiring ongoing
maintenance therapy.

- Persistent fever, active persistent diarrhea, or continued severe weight loss.

- Severe premorbid psychiatric illness.

- Confounding neurologic disease or deficit.

- Concurrent or previous central nervous system infections or neoplasms.

- Concurrent active neoplasms other than basal cell carcinoma of the skin and
mucocutaneous Kaposi's sarcoma.

Prior Medication:

Excluded within 2 weeks of study entry or for greater than 2 weeks of therapy:

- Zidovudine (AZT).

- Patients must not have previously exhibited toxic reaction to AZT.

- Excluded within 30 days of study entry:

- Immunomodulators and biologic response modifiers, including systemic steroids.

- Any investigational agent.

- Cytotoxic chemotherapy for Kaposi's sarcoma.

Prior Treatment:

Excluded within 30 days of study entry:

- Radiation therapy.

- Excluded within 2 weeks of study entry:

- Blood transfusion.

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

RW Price

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 061

NCT ID:

NCT00000709

Start Date:

Completion Date:

February 1990

Related Keywords:

  • AIDS Dementia Complex
  • HIV Infections
  • Neuropsychological Tests
  • AIDS Dementia Complex
  • Zidovudine
  • CD4-Positive T-Lymphocytes
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • AIDS Dementia Complex
  • Dementia

Name

Location

Bellevue Hosp / New York Univ Med CtrNew York, New York  10016
Mem Sloan - Kettering Cancer CtrNew York, New York  10021
Univ of Rochester Medical CenterRochester, New York  14642
Julio ArroyoWest Columbia, South Carolina  29169
UCLA CARE CtrLos Angeles, California  90095
Louisiana State Univ Med Ctr / Tulane Med SchoolNew Orleans, Louisiana  70112
Tulane Univ School of MedicineNew Orleans, Louisiana  70112
Univ of North CarolinaChapel Hill, North Carolina  275997215
Univ Hosp of Cleveland / Case Western Reserve UnivCleveland, Ohio  44106
Univ of WashingtonSeattle, Washington  98105
Johns Hopkins HospBaltimore, Maryland  21287
Charity Hosp / Tulane Univ Med SchoolNew Orleans, Louisiana  70112