Clinical Trial: 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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter Placebo-Controlled Double-Blind Trial to Evaluate Azidothymidine (AZT) Treatment of the AIDS Dementia Complex and Central Nervous System (CNS) Human Immunode

Brief 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.

Detailed Summary:

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.

The study is done in 2 stages. In Stage 1, patients are randomized to receive placebo or 1 of 2 doses of AZT. Stage 1 lasts for 4 months. In Stage 2, patients who were initially treated with placebo are randomized again and all patients receive AZT. Stage 2 lasts an additional 12 months, during which time there are periodic medical and neurologic evaluations. Before beginning treatment, all patients have a lumbar puncture and a computerized tomographic (CT) scan of the brain. The lumbar puncture is repeated twice during and once at the end of Stage 1; the CT scan is also repeated at the end of Stage 1. Patients receiving AZT in either stage 1 or Stage 2 are seen by their physicians every week for the first 4 weeks and every other week thereafter for the first 4 months of receiving the drug. After 4 months, patients are seen by their physicians at 4 to 12 week intervals.

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Current Primary Outcome:

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Original Secondary Outcome:

Information By: National Institute of Allergy and Infectious Diseases (NIAID)

Dates:
Date Received: November 2, 1999
Date Started:
Date Completion:
Last Updated: February 15, 2012
Last Verified: February 2012