A Multicenter Placebo-Controlled Double-Blind Trial to Evaluate Azidothymidine (AZT) Treatment of… (NCT00000702) | Clinical Trial Compass
CompletedPhase 3
A Multicenter Placebo-Controlled Double-Blind Trial to Evaluate Azidothymidine (AZT) Treatment of the AIDS Dementia Complex and Central Nervous System (CNS) Human Immunodeficiency Virus (HIV) Infection
United States315 participants
Plain-language summary
To test whether zidovudine (AZT) is useful as a treatment for the neurologic syndrome called AIDS dementia complex. To determine how long AZT takes to reach cerebral spinal fluid (CSF), how long, and at what concentration it is found there.
HIV infection can result in impairment in the function of the brain and spinal cord, leading to disturbances in the ability to think clearly and in strength and coordination. This disorder, which has been called the AIDS dementia complex, may be due to a direct effect of HIV on the nervous system. It is known that AZT does get into the brain to some extent, where it may reduce growth of HIV. It is hoped that AZT will stabilize or improve the symptoms of the AIDS dementia complex.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
Concurrent Medication:
Allowed:
* Aspirin, in modest doses.
* Ibuprofen, in modest doses.
* Maintenance antibiotic therapy posttherapy for an AIDS-defining opportunistic infection.
Concurrent Treatment:
Allowed:
* Blood transfusion if cardiovascular status is compromised.
Exclusion Criteria
* Active substance abuse.
Co-existing Condition:
Patients with the following conditions will be excluded:
* Concurrent or previous central nervous system infections or neoplasms.
* Active AIDS-defining opportunistic infection.
* Severe premorbid psychiatric illness.
* Confounding neurological disease.
* Concurrent neoplasms.
Concurrent Medication:
Excluded:
* Maintenance methadone or naltrexone.
* Acetaminophen.
* Mood- or central nervous system-altering drugs.
* Zidovudine for Pneumocystis carinii pneumonia (PCP).
* Acyclovir.
* Rifampin or derivatives.
* Drugs with antiretroviral activity.
* Experimental agents.
The following patients will be excluded from the study:
* Patients requiring ongoing therapy for an AIDS-defining opportunistic infection.
* Patients with a history of Mycobacterium avium intracellulare infection.
* Patients with a history of Pneumocystis carinii pneumonia infection.
* Patients with a daily temperature of 38 degrees C or more for 1 month.
Prior Medication:
Excluded:
* Zidovudine (AZT).
* Excluded within 14 days of study entry:
* Systemic anti-infectives.
* Excluded within 30 days of study entry:
* Immunomodulators and biologi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00000702
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)