A Study to Evaluate the Safety and Tolerability of Zidovudine (ZDV) in Premature Infants Born to HIV-Positive Women.
|First Received Date ICMJE||November 2, 1999|
|Last Updated Date||March 15, 2012|
|Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00000855 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|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.|
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.
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 ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Endpoint Classification: Pharmacokinetics Study
Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||HIV Infections|
|Intervention ICMJE||Drug: Zidovudine|
|Study Arm (s)||Not Provided|
|Publications *||Capparelli EV, Mirochnick M, Dankner WM, Blanchard S, Mofenson L, McSherry GD, Gay H, Ciupak G, Smith B, Connor JD; Pediatric AIDS Clinical Trials Group 331 Investigators. Pharmacokinetics and tolerance of zidovudine in preterm infants. J Pediatr. 2003 Jan;142(1):47-52.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||February 2000|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Your baby may be eligible for this study if he/she:
Your baby will not be eligible for this study if he/she:
|Ages||up to 5 Days|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States, Puerto Rico|
|Removed Location Countries|
|NCT Number ICMJE||NCT00000855|
|Other Study ID Numbers ICMJE||ACTG 331, 11303|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||National Institute of Allergy and Infectious Diseases (NIAID)|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institute of Allergy and Infectious Diseases (NIAID)|
|Verification Date||March 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP