Completed

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

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What is being tested

Zidovudine

Drug
Who is being recruted

HIV Infections

Over 12 Years
How is the trial designed

Treatment Study

Phase 3
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
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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. 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.

Official TitleThe Safety and Efficacy of Zidovudine in the Treatment of Patients With Early AIDS Related Complex 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
538 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 12 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
Criteria

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.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 40 locations
Suspended
Los Angeles County - USC Med CtrLos Angeles, United StatesSee the location
Suspended
UCLA CARE CtrLos Angeles, United States
Suspended
Palo Alto Veterans Adm Med Ctr / Stanford UnivPalo Alto, United States
Suspended
Univ of California / San Diego Treatment CtrSan Diego, United States

Completed40 Study Centers