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| ID | Type | Description | Link |
|---|---|---|---|
| 11035 | Registry Identifier | DAIDS ES Registry Number |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zidovudine | Drug |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients with the following are included:
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:
Concurrent Medication:
Excluded:
Patients with the following will be excluded from the study:
Prior Medication:
Excluded within 2 weeks of study entry or for greater than 2 weeks of therapy:
Prior Treatment:
Excluded within 30 days of study entry:
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| Name | Affiliation | Role |
|---|---|---|
| RW Price | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA CARE Ctr | Los Angeles | California | 90095 | United States | ||
| Charity Hosp / Tulane Univ Med School |
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| 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 |
| ID | Term |
|---|---|
| D015526 | AIDS Dementia Complex |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015215 | Zidovudine |
| ID | Term |
|---|---|
| D013936 | Thymidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015224 | Dideoxynucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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