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NCT00001011

The Safety and Effectiveness of Zidovudine in the Treatment of Patients With Early AIDS Related Complex

Last Updated: 2021-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

538 participants

Study Classification

INTERVENTIONAL

Study Completion Date

1995-02-28

Brief Summary

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To determine the safety and usefulness of zidovudine (AZT) for the treatment of patients with early symptomatic HIV infection or early AIDS related complex (ARC). The ability of AZT to suppress HIV, to improve body defenses, and to prevent the occurrence or development of AIDS or advanced ARC is being evaluated.

In one human study, patients with AIDS or advanced ARC who received AZT had fewer life-threatening infections, improved in weight and performance, and lived longer than patients who received a placebo (inactive medication). Further studies are needed because toxic effects associated with the use of AZT were noted and the long-term effectiveness and toxicity of AZT are still unknown. It is also unknown if AZT will benefit patients with less severe HIV infections such as early ARC or PGL.

Detailed Description

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In one human study, patients with AIDS or advanced ARC who received AZT had fewer life-threatening infections, improved in weight and performance, and lived longer than patients who received a placebo (inactive medication). Further studies are needed because toxic effects associated with the use of AZT were noted and the long-term effectiveness and toxicity of AZT are still unknown. It is also unknown if AZT will benefit patients with less severe HIV infections such as early ARC or PGL.

Patients accepted into the study are randomly assigned to receive either AZT or placebo. Treatment continues for a minimum of 104 weeks beyond the time the last patient enters the study. If the study medication causes toxic effects, the dose is decreased or temporarily stopped, and if the toxic effects are severe, then the medication will be stopped permanently. Participants visit the clinic every 2 weeks during the first 16 weeks and once a month thereafter. Throughout the study frequent blood samples are taken to monitor the effectiveness and safety of the treatment. AMENDED: The placebo arm has been discontinued as of August 3, 1989 and the AZT dose has been reduced.

Conditions

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HIV Infections

Keywords

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Virus Replication AIDS-Related Complex Zidovudine

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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Zidovudine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients must have a positive antibody to HIV confirmed by a federally licensed ELISA test kit.
* The CD4 cell count must be 201 - 799 cells/mm3 measured on two separate occasions within 60 days at least 72 hours apart prior to study entry (at least 1 of 2 counts and the mean must be \< 800 cells/mm3, and at least 1 of 2 counts and the mean must be \> 200 cells/mm3). The last count must be within 14 days of study entry.

Concurrent Medication:

Allowed:

* Acetaminophen and acetaminophen products but use should be minimized. Continuous use for \> 72 hours is discouraged.
* Aerosolized pentamidine.

Prior Medication:

Allowed:

* Chemoprophylaxis for Pneumocystis carinii pneumonia with aerosolized pentamidine of 300 mg every 4 weeks through the Respirgard II nebulizer if patient has CD4(+) count \< 200 cells/mm3 measured on 2 determinations at least 48 hours apart.

Exclusion Criteria

Concurrent Medication:

Excluded:

* Other antiretroviral agents, biologic modifiers or corticosteroids.
* Other experimental medications.
* Systemic chemoprophylaxis of Pneumocystic carinii pneumonia (PCP) - aerosolized pentamidine is allowed.

Prior Medication:

Excluded:

* Zidovudine (AZT).
* Other antiretroviral agents.
* Excluded within 30 days of study entry:
* Biologic modifiers or corticosteroids.
* Excluded within 60 days of study entry:
* Ribavirin.

Prior Treatment:

Excluded within 30 days of study entry:

* Blood transfusions.

Patients may not have any of the following diseases or symptoms:

* Active oral candidiasis at entry.
* An opportunistic infection or malignancy fulfilling the definition of AIDS (CDC Surveillance Case Definition for Acquired Immunodeficiency Syndrome).
* Temperature \> 38.5 degrees C persisting for \> 14 consecutive days or \> 15 days in a 30-day interval present at entry.
* Chronic diarrhea defined as = or \> 3 liquid stools per day, persisting for \> 14 days without a definable cause during the past 2 years.
* HIV neurologic disease as manifested by motor abnormalities including impaired rapid eye movements or ataxia; motor weakness in the lower extremities; sensory deficit consistent with a peripheral neuropathy; bladder or bowel incontinence.
* Concurrent neoplasms other than basal cell carcinoma of the skin or in situ carcinoma of the cervix.
* Subjects with hemophilia should be evaluated and treated under the hemophilia protocols, if available at that ACTG.

Patients may not have any of the following diseases or symptoms:

* Active oral candidiasis at entry.
* An opportunistic infection or malignancy fulfilling the definition of AIDS (CDC Surveillance Case Definition for Acquired Immunodeficiency Syndrome).
* Temperature \> 38.5 degrees C persisting for \> 14 consecutive days or \> 15 days in a 30-day interval present at entry.
* Chronic diarrhea defined as = or \> 3 liquid stools per day, persisting for \> 14 days without a definable cause during the past 2 years.
* HIV neurologic disease as manifested by motor abnormalities including impaired rapid eye movements or ataxia; motor weakness in the lower extremities; sensory deficit consistent with a peripheral neuropathy; bladder or bowel incontinence.
* Concurrent neoplasms other than basal cell carcinoma of the skin or in situ carcinoma of the cervix.
* Subjects with hemophilia should be evaluated and treated under the hemophilia protocols, if available at that ACTG.

Active drug or alcohol abuse.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MA Fischl

Role: STUDY_CHAIR

DD Richman

Role: STUDY_CHAIR

Locations

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Los Angeles County - USC Med Ctr

Los Angeles, California, United States

Site Status

UCLA CARE Ctr

Los Angeles, California, United States

Site Status

Palo Alto Veterans Adm Med Ctr / Stanford Univ

Palo Alto, California, United States

Site Status

Univ of California / San Diego Treatment Ctr

San Diego, California, United States

Site Status

Stanford at Kaiser / Kaiser Permanente Med Ctr

San Francisco, California, United States

Site Status

Stanford Univ School of Medicine

Stanford, California, United States

Site Status

Harbor UCLA Med Ctr

Torrance, California, United States

Site Status

George Washington Univ Med Ctr

Washington D.C., District of Columbia, United States

Site Status

Univ of Miami School of Medicine

Miami, Florida, United States

Site Status

Northwestern Univ Med School

Chicago, Illinois, United States

Site Status

Indiana Univ Hosp

Indianapolis, Indiana, United States

Site Status

Johns Hopkins Hosp

Baltimore, Maryland, United States

Site Status

Harvard (Massachusetts Gen Hosp)

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess - West Campus

Boston, Massachusetts, United States

Site Status

Univ of Minnesota

Minneapolis, Minnesota, United States

Site Status

St Louis Regional Hosp / St Louis Regional Med Ctr

St Louis, Missouri, United States

Site Status

SUNY / Erie County Med Ctr at Buffalo

Buffalo, New York, United States

Site Status