An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts
NCT ID: NCT00000709
Last Updated: 2021-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
50 participants
INTERVENTIONAL
1990-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Zidovudine
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
RW Price
Role: STUDY_CHAIR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UCLA CARE Ctr
Los Angeles, California, United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, United States
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, United States
Tulane Univ School of Medicine
New Orleans, Louisiana, United States
Johns Hopkins Hosp
Baltimore, Maryland, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States
Univ of Rochester Medical Center
Rochester, New York, United States
Univ of North Carolina
Chapel Hill, North Carolina, United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, United States
Julio Arroyo
West Columbia, South Carolina, United States
Univ of Washington
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
11035
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 061
Identifier Type: -
Identifier Source: org_study_id