Search / Trial NCT00000702

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Apply for Trial

Trial Information

Current as of April 22, 2024

Completed

Keywords

Aids Dementia Complex Zidovudine

Description

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. S...

Gender

All

Eligibility criteria

  • 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 biologic response modifiers.
  • Any investigational agent.
  • Cytotoxic chemotherapy for Kaposi's sarcoma.
  • Prior Treatment:
  • Excluded:
  • Radiation therapy.
  • Patients must demonstrate the following clinical and laboratory findings:
  • No currently active AIDS-defining opportunistic infections.
  • One negative blood culture for Mycobacterium avium intracellulare within 4-6 weeks prior to study entry.
  • Constitutionally well without persistent fever.
  • Less than 25 Kaposi's sarcoma lesions and less than 10 new lesions during the 30 days prior to study entry. Patients may have stable or indolently progressive mucocutaneous Kaposi's sarcoma.
  • Characteristic clinical symptoms and signs of AIDS dementia complex.
  • Abnormalities on 2 or more of 7 neuropsychological motor tests in the Neurological Screening Battery.
  • Estimated premorbid IQ equal to or greater than 70 (+ or - 5), which is consistent with completion of sixth grade.

Attachments

readout_NCT00000702_2024-04-22.pdf

4.5 MB

NCT00000702_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

New York, New York, United States

West Columbia, South Carolina, United States

Seattle, Washington, United States

San Diego, California, United States

New York, New York, United States

Rochester, New York, United States

Miami, Florida, United States

Baltimore, Maryland, United States

Bronx, New York, United States

Bronx, New York, United States

Buffalo, New York, United States

Elmhurst, New York, United States

Boston, Massachusetts, United States

Los Angeles, California, United States

New York, New York, United States

New Orleans, Louisiana, United States

New Orleans, Louisiana, United States

New Orleans, Louisiana, United States

New York, New York, United States

Stanford, California, United States

Boston, Massachusetts, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Discussion 0