An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts
2 other identifiers
interventional
50
1 country
12
Brief Summary
To provide accurate and complete neurologic assessment of the course of the AIDS dementia complex in patients treated with zidovudine (AZT). The study will determine how frequently patients improve, how long improvement is sustained, and the magnitude and functional significance of improvement. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
February 1, 1990
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedOctober 29, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- +1 more criteria
You may not qualify if:
- 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.
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
UCLA CARE Ctr
Los Angeles, California, 90095, United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112, United States
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, 70112, United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Mem Sloan - Kettering Cancer Ctr
New York, New York, 10021, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106, United States
Julio Arroyo
West Columbia, South Carolina, 29169, United States
Univ of Washington
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
RW Price
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
February 1, 1990
Last Updated
October 29, 2021
Record last verified: 2021-10