Completed

A Study of Zidovudine in Infants Exposed to the HIV Before or Soon After Birth

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What is being tested

Zidovudine

Drug
Who is being recruted

HIV Infections

Until 3 Months
How is the trial designed

Treatment Study

Phase 1
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: July 15, 2008
Sourced from a government-validated database.Claim as a partner

To determine if intravenous (IV) and oral zidovudine (AZT) can be safely given to children aged 1 day to 3 months who were born to mothers with an HIV infection. Also to determine the correct dose of AZT for young children. Of a total of 908 pediatric AIDS cases, 78 percent have acquired HIV infection from a mother with HIV infection or at high risk for acquisition of HIV, and the number of cases in children is expected to increase over the next several years. AZT therapy may be effective in altering the course of the disease and decreasing the high mortality in these children. It is also possible that early intervention with AZT may prevent the establishment of HIV contracted before, during, or just after birth. Of a total of 908 pediatric AIDS cases, 78 percent have acquired HIV infection from a mother with HIV infection or at high risk for acquisition of HIV, and the number of cases in children is expected to increase over the next several years. AZT therapy may be effective in altering the course of the disease and decreasing the high mortality in these children. It is also possible that early intervention with AZT may prevent the establishment of HIV contracted before, during, or just after birth. The children entered in this study receive oral and IV AZT. The first 6 children receive 2 IV doses and 2 oral doses over a 2-week period, then 4 weeks of continuous oral dosing (4 doses per day). The remaining 12 children receive 1 IV dose and 1 oral dose followed by 6 weeks of oral AZT (4 doses per day) and a second IV dose at the end of the study. Each child is under the care of a specialist in pediatrics and has a physical examination and laboratory tests before starting AZT and 6 times while taking AZT to make sure the drug is not having a toxic effect on the child. A single cerebrospinal fluid (CSF) sample is taken from the last 12 children entering the study, so that the level of the AZT reaching the brain can be measured. The child returns to the hospital or clinic 4 weeks after the end of therapy to make sure that there are no delayed toxic effects.

Official TitleA Multicenter Phase I Trial To Evaluate the Safety and Pharmacokinetics of Intravenous and Oral Zidovudine in Infants With Perinatal Human Immunodeficiency Virus (HIV) Exposure 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: July 15, 2008
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
18 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 the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

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 allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
Criteria

Inclusion Criteria Infant gestation period must have been = or \> 36 weeks and birthweight must = or \> 2000 grams. Active infection must not be present at the time of entry into the study although an HIV culture or P24 serum antigen determination must be obtained prior to study entry. The child must have a life expectancy greater than 3 months. Parents or guardian must be available to give informed consent. Prior Medication: Allowed on a case-by-case basis: * Some essential supportive therapies including antibiotics. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: * Any of the following laboratory findings within 2 weeks of study entry. * A total bilirubin \> 2 times age-adjusted upper limit of normal. * Liver transaminase values \> 3 x upper limit of normal. * Serum creatinine \> 1.5 x upper limit of normal. * Total granulocyte count \< 1500 cells/mm3. * Hemoglobin \< 10 g/dl or hemoglobinopathy. * A urine toxicology screen positive for any drug or chemical. * Infants must not have hemoglobinopathy or active infection at entry. Prior Medication: Excluded within 2 months of study entry: * Antiretroviral agents. * Excluded within 4 weeks of study entry: * Immunomodulating agents including steroids, interferon, isoprinosine, and interleukin. * Immunoglobulin. * Excluded within 2 weeks of study entry: * Any other experimental therapy, drugs which cause prolonged neutropenia or significant nephrotoxicity, or rifampin / rifampin derivatives. * Some essential supportive therapies including antibiotics may have infrequent or transient effects. These drugs will be considered on a case-by-case basis. Prior Treatment: Excluded within 2 weeks of study entry: * Red blood cells or whole blood transfusion. * Excluded within 4 weeks of study entry: * Lymphocyte transfusions for immune reconstitution. Infants may not be entered into the study during the first 2 weeks of life if their mother received methadone therapy during the last trimester of her pregnancy or used any known illicit drug. A maternal urine toxicology screen may be optionally performed prior to entry of the child, and children whose mothers have a screen which is positive for any drugs or chemicals may not be enrolled within 2 weeks of the positive screen.



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 6 locations
Suspended
Univ of Alabama at BirminghamBirmingham, United StatesSee the location
Suspended
Stanford Univ School of MedicineStanford, United States
Suspended
Johns Hopkins Hosp - PediatricBaltimore, United States
Suspended
Johns Hopkins HospBaltimore, United States

Completed6 Study Centers