|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000855 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Zidovudine |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Safety, Tolerance, and Pharmacokinetics of Zidovudine in Premature Infants Exposed to HIV. |
| Estimated Enrollment: | 35 |
| Primary Completion Date: | February 2000 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | up to 5 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
Contacts and Locations
Show 36 Study Locations| Study Chair: | Mirochnick M | |
| Study Chair: | Dankner D | |
| Study Chair: | Capparelli E |
More Information
| ClinicalTrials.gov Identifier: | NCT00000855 History of Changes |
| Other Study ID Numbers: | ACTG 331 |
| Study First Received: | November 2, 1999 |
| Last Updated: | March 1, 2011 |
| Health Authority: | United States: Federal Government |
|
Zidovudine Anti-HIV Agents |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Zidovudine |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
