An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts
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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.
Condition | Intervention | Phase |
---|---|---|
AIDS Dementia Complex HIV Infections |
Drug: Zidovudine |
Phase 3 |
Study Type: | Interventional |
Study Design: | Masking: Open Label Primary Purpose: Treatment |
Official Title: | An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts |
Estimated Enrollment: | 50 |
Study Completion Date: | February 1990 |
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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Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
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United States, California | |
UCLA CARE Ctr | |
Los Angeles, California, United States, 90095 | |
United States, Louisiana | |
Charity Hosp / Tulane Univ Med School | |
New Orleans, Louisiana, United States, 70112 | |
Louisiana State Univ Med Ctr / Tulane Med School | |
New Orleans, Louisiana, United States, 70112 | |
Tulane Univ School of Medicine | |
New Orleans, Louisiana, United States, 70112 | |
United States, Maryland | |
Johns Hopkins Hosp | |
Baltimore, Maryland, United States, 21287 | |
United States, New York | |
Mem Sloan - Kettering Cancer Ctr | |
New York, New York, United States, 10021 | |
Bellevue Hosp / New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
Univ of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
United States, North Carolina | |
Univ of North Carolina | |
Chapel Hill, North Carolina, United States, 275997215 | |
United States, Ohio | |
Univ Hosp of Cleveland / Case Western Reserve Univ | |
Cleveland, Ohio, United States, 44106 | |
United States, South Carolina | |
Julio Arroyo | |
West Columbia, South Carolina, United States, 29169 | |
United States, Washington | |
Univ of Washington | |
Seattle, Washington, United States, 98105 |
Study Chair: | RW Price |
![](https://webarchive.library.unt.edu/web/20130307130358im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Additional Information:
No publications provided
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000709 History of Changes |
Other Study ID Numbers: | ACTG 061, 11035 |
Study First Received: | November 2, 1999 |
Last Updated: | March 15, 2012 |
Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Neuropsychological Tests AIDS Dementia Complex Zidovudine CD4-Positive T-Lymphocytes |
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome HIV Infections AIDS Dementia Complex Dementia Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Zidovudine Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on March 05, 2013