- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000855
A Study to Evaluate the Safety and Tolerability of Zidovudine (ZDV) in Premature Infants Born to HIV-Positive Women.
The Safety, Tolerance, and Pharmacokinetics of Zidovudine in Premature Infants Exposed to HIV.
The purpose of this study is to examine the safety and tolerability of ZDV when given to premature infants born to HIV-positive women to prevent HIV infection.
ZDV has been used successfully to prevent the transmission of HIV from mother to child during pregnancy and birth. However, ZDV has been given to very few premature babies, and the best dose to use has not yet been determined.
Study Overview
Detailed Description
In the preliminary group of premature infants, those receiving q 6h dosing had an average trough concentration of 7.3 uM (18%). However, the premature infants in the preliminary pharmacokinetic study did not have long term follow-up to assess toxicity. Due to the potential for altered ZDV pharmacokinetics and increased toxicity in this population, an evaluation of ZDV pharmacokinetics in premature infants is proposed.
Premature infants less than or equal to 34 weeks gestational age at birth and begun on ZDV by their clinical caregivers will be entered into the protocol within the first 5 days of life. Upon entry, ZDV will be administered every 12 hours intravenously or orally. The study will require 9 serum samples for ZDV assay collected over 30 days, some additional clinical laboratory tests collected over 12 weeks, collection of 3 spot urine samples, and collection of routine clinical data.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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San Juan, Puerto Rico, 009365067
- Univ of Puerto Rico / Univ Children's Hosp AIDS
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Alabama
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Birmingham, Alabama, United States, 35233
- Univ of Alabama at Birmingham - Pediatric
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Arizona
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Phoenix, Arizona, United States, 85006
- Phoenix Childrens Hosp
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California
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La Jolla, California, United States, 920930672
- UCSD Med Ctr / Pediatrics / Clinical Sciences
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Los Angeles, California, United States, 90033
- Los Angeles County - USC Med Ctr
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Los Angeles, California, United States, 905022004
- Harbor - UCLA Med Ctr / UCLA School of Medicine
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Los Angeles, California, United States, 900951752
- UCLA Med Ctr / Pediatric
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Oakland, California, United States, 946091809
- Children's Hosp of Oakland
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San Francisco, California, United States, 94110
- San Francisco Gen Hosp
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San Francisco, California, United States, 941430105
- UCSF / Moffitt Hosp - Pediatric
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Florida
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Gainesville, Florida, United States, 32610
- Univ of Florida Gainesville
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Jacksonville, Florida, United States, 32209
- Univ of Florida Health Science Ctr / Pediatrics
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Miami, Florida, United States, 33161
- Univ of Miami (Pediatric)
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Miami, Florida, United States, 33136
- Univ of Miami / Jackson Memorial Hosp
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Georgia
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Atlanta, Georgia, United States, 30306
- Emory Univ Hosp / Pediatrics
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Illinois
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Chicago, Illinois, United States, 606371470
- Univ of Chicago Children's Hosp
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Chicago, Illinois, United States, 60612
- Univ of Illinois College of Medicine / Pediatrics
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Indiana
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Indianapolis, Indiana, United States, 46202
- Division of Inf Diseases/ Indiana Univ Hosp
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Massachusetts
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Boston, Massachusetts, United States, 021155724
- Children's Hosp of Boston
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Boston, Massachusetts, United States, 02118
- Boston City Hosp / Pediatrics
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Worcester, Massachusetts, United States, 016550001
- Univ of Massachusetts Med School
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Mississippi
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Jackson, Mississippi, United States, 39213
- Univ of Mississippi Med Ctr
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New Jersey
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Newark, New Jersey, United States, 071032714
- Univ of Medicine & Dentistry of New Jersey / Univ Hosp
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New York
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Albany, New York, United States, 12208
- Children's Hosp at Albany Med Ctr
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New York, New York, United States, 10032
- Columbia Presbyterian Med Ctr
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New York, New York, United States, 10037
- Harlem Hosp Ctr
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Rochester, New York, United States, 146420001
- Univ of Rochester Med Ctr
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Stony Brook, New York, United States, 117948111
- State Univ of New York at Stony Brook
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Syracuse, New York, United States, 13210
- SUNY Health Sciences Ctr at Syracuse / Pediatrics
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Valhalla, New York, United States, 10595
- Westchester Hosp
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North Carolina
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Durham, North Carolina, United States, 277103499
- Duke Univ Med Ctr
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South Carolina
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Charleston, South Carolina, United States, 294253312
- Med Univ of South Carolina
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Texas
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Dallas, Texas, United States, 75235
- Children's Med Ctr of Dallas
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Virginia
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Norfolk, Virginia, United States, 23507
- Children's Hosp of the King's Daughters
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Richmond, Virginia, United States, 23219
- Med College of Virginia
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Washington
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Seattle, Washington, United States, 981050371
- Children's Hospital & Medical Center / Seattle ACTU
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Your baby may be eligible for this study if he/she:
- Requires ZDV (as decided by your doctor) because you are HIV-positive.
- Is 1-5 days old and was born prematurely.
Exclusion Criteria
Your baby will not be eligible for this study if he/she:
- Is not expected to live 6 weeks because of severe illness.
- Is having problems with blood pressure or is not urinating enough.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Investigators
- Study Chair: Mirochnick M
- Study Chair: Dankner D
- Study Chair: Capparelli E
Publications and helpful links
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Zidovudine
Other Study ID Numbers
- ACTG 331
- 11303 (Registry Identifier: DAIDS ES Registry Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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