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| Tracking Information | |||||||||||||
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| First Received Date ICMJE | November 2, 1999 | ||||||||||||
| Last Updated Date | July 29, 2008 | ||||||||||||
| Start Date ICMJE | |||||||||||||
| Primary Completion Date | |||||||||||||
| Current Primary Outcome Measures ICMJE | |||||||||||||
| Original Primary Outcome Measures ICMJE | |||||||||||||
| Change History | Complete list of historical versions of study NCT00000855 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | A Study to Evaluate the Safety and Tolerability of Zidovudine (ZDV) in Premature Infants Born to HIV-Positive Women. | ||||||||||||
| Official Title ICMJE | The Safety, Tolerance, and Pharmacokinetics of Zidovudine in Premature Infants Exposed to HIV. | ||||||||||||
| Brief Summary | 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. |
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| 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. |
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| Study Phase | |||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Design ICMJE | Treatment, Open Label, Pharmacokinetics Study | ||||||||||||
| Condition ICMJE | HIV Infections | ||||||||||||
| Intervention ICMJE | Drug: Zidovudine | ||||||||||||
| Study Arms / Comparison Groups | |||||||||||||
| Publications * | Capparelli EV, Mirochnick M, Dankner WM, Blanchard S, Mofenson L, McSherry GD, Gay H, Ciupak G, Smith B, Connor JD. Pharmacokinetics and tolerance of zidovudine in preterm infants. J Pediatr. 2003 Jan;142(1):47-52. | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Enrollment ICMJE | 35 | ||||||||||||
| Completion Date | |||||||||||||
| Primary Completion Date | |||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria Your baby may be eligible for this study if he/she:
Exclusion Criteria Your baby will not be eligible for this study if he/she:
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| Gender | Both | ||||||||||||
| Ages | up to 5 Days | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | United States, Puerto Rico | ||||||||||||
| Administrative Information | |||||||||||||
| NCT ID ICMJE | NCT00000855 | ||||||||||||
| Responsible Party | |||||||||||||
| Study ID Numbers ICMJE | ACTG 331 | ||||||||||||
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||||||
| Collaborators ICMJE | |||||||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||||||
| Verification Date | January 2003 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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