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The Safety and Effectiveness of Hyperimmune Anti-HIV Intravenous Immunoglobulin (HVIG) Plus Zidovudine in HIV-Infected Infants

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What is being tested

Anti-HIV Immune Serum Globulin (Human)

+ Zidovudine
Drug
Who is being recruted

HIV Infections

Until 3 Months
How is the trial designed

Treatment Study

Phase 2
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
Sourced from a government-validated database.Claim as a partner

To determine the safety and tolerance of hyperimmune anti-HIV intravenous immunoglobulin (HIVIG) and of zidovudine (AZT) in infants with established HIV infection; to get preliminary evidence for the effectiveness of this type of treatment in preventing the advance of disease in HIV infected infants. HIVIG may be an effective agent that either alone or in combination with AZT will prevent progression of clinical disease. HIVIG may be an effective agent that either alone or in combination with AZT will prevent progression of clinical disease. Participants are randomized to receive either oral AZT or HIVIG. Patients may receive treatment for a maximum of 48 weeks. Patients are evaluated during treatment at weeks 2, 4, and every 4 weeks thereafter. Infants who are receiving HIVIG initially are treated with the appropriate age-adjusted dose of oral AZT in addition to HIVIG if they meet clinical disease progression criteria. All participants who have completed 48 weeks of treatment or who are discontinued from treatment are followed every 3 months for an additional 48 weeks. This follow-up may be conducted over the telephone.

Official TitleA Phase II Study to Evaluate the Safety, Tolerance and Efficacy of Hyperimmune Anti-HIV Intravenous Immunoglobulin (HIVIG) and of Zidovudine (ZDV) in Infants With Documented HIV Infections 
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
112 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.
Until 3 MonthsRange 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 Concurrent Medication: Allowed: * Recommended: * Standard immunizations. Should repeat MMR 3 months after discontinuing study. * Benadryl and/or aspirin. * Pneumocystis carinii pneumonia prophylaxis. * Systemic ketoconazole and acyclovir, or oral nystatin for acute therapy. * Aerosol ribavirin for short-term treatment of RSV. Concurrent Treatment: Allowed: * Blood transfusion. Patients must have the following: * Parent or guardian available to give written informed consent. * Protocol requires prior Institutional Review Board (IRB) approval before any subject is entered into study. Prior Medication: Allowed: * Gammaglobulin, intravenous (IV) or intramuscular (IM). * Immunoglobulin, IV (IVIG). * Maternal antiretroviral treatment during pregnancy. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: * Symptomatic of any class P-2 symptoms (except lymphadenopathy at time of study entry. * Presence of serious acute infection requiring parenteral treatment at time of study entry. Concurrent Medication: Excluded: * Prophylaxis for oral candidiasis or otitis media or other infections. * Immunoglobulin therapy (except single dose or for hypogammaglobulinemia). * Ketoconazole, acyclovir, or nystatin for prophylaxis. Patients with the following are excluded: * Symptomatic of any class P-2 symptoms (except lymphadenopathy at time of study entry. * Presence of serious acute infection requiring parenteral treatment at time of study entry. Prior Medication: Excluded: * Antiretroviral treatment or experimental treatment within 2 weeks of entry.



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.
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SuspendedNo study centers