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An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts

Primary Purpose

AIDS Dementia Complex, HIV Infections

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Zidovudine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for AIDS Dementia Complex focused on measuring Neuropsychological Tests, AIDS Dementia Complex, Zidovudine, CD4-Positive T-Lymphocytes

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA CARE Ctr
  • Charity Hosp / Tulane Univ Med School
  • Louisiana State Univ Med Ctr / Tulane Med School
  • Tulane Univ School of Medicine
  • Johns Hopkins Hosp
  • Bellevue Hosp / New York Univ Med Ctr
  • Mem Sloan - Kettering Cancer Ctr
  • Univ of Rochester Medical Center
  • Univ of North Carolina
  • Univ Hosp of Cleveland / Case Western Reserve Univ
  • Julio Arroyo
  • Univ of Washington

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000709
Brief Title
An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts
Official Title
An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 1990 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AIDS Dementia Complex, HIV Infections
Keywords
Neuropsychological Tests, AIDS Dementia Complex, Zidovudine, CD4-Positive T-Lymphocytes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RW Price
Official's Role
Study Chair
Facility Information:
Facility Name
UCLA CARE Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Charity Hosp / Tulane Univ Med School
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Louisiana State Univ Med Ctr / Tulane Med School
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tulane Univ School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Bellevue Hosp / New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mem Sloan - Kettering Cancer Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Univ of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Univ of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
275997215
Country
United States
Facility Name
Univ Hosp of Cleveland / Case Western Reserve Univ
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Julio Arroyo
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Univ of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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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