A Study to Evaluate the Safety and Tolerability of Zidovudine (ZDV) in Premature Infants Born to HIV-Positive Women.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000855

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Zidovudine	N/A

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 Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Safety, Tolerance, and Pharmacokinetics of Zidovudine in Premature Infants Exposed to HIV.

Actual Study Completion Date :

Feb 1, 2000

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 5 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of Alabama at Birmingham - Pediatric	Birmingham	Alabama	United States	35233
2	Phoenix Childrens Hosp	Phoenix	Arizona	United States	85006
3	UCSD Med Ctr / Pediatrics / Clinical Sciences	La Jolla	California	United States	920930672
4	Los Angeles County - USC Med Ctr	Los Angeles	California	United States	90033
5	UCLA Med Ctr / Pediatric	Los Angeles	California	United States	900951752
6	Harbor - UCLA Med Ctr / UCLA School of Medicine	Los Angeles	California	United States	905022004
7	Children's Hosp of Oakland	Oakland	California	United States	946091809
8	San Francisco Gen Hosp	San Francisco	California	United States	94110
9	UCSF / Moffitt Hosp - Pediatric	San Francisco	California	United States	941430105
10	Univ of Florida Gainesville	Gainesville	Florida	United States	32610
11	Univ of Florida Health Science Ctr / Pediatrics	Jacksonville	Florida	United States	32209
12	Univ of Miami / Jackson Memorial Hosp	Miami	Florida	United States	33136
13	Univ of Miami (Pediatric)	Miami	Florida	United States	33161
14	Emory Univ Hosp / Pediatrics	Atlanta	Georgia	United States	30306
15	Univ of Illinois College of Medicine / Pediatrics	Chicago	Illinois	United States	60612
16	Univ of Chicago Children's Hosp	Chicago	Illinois	United States	606371470
17	Division of Inf Diseases/ Indiana Univ Hosp	Indianapolis	Indiana	United States	46202
18	Children's Hosp of Boston	Boston	Massachusetts	United States	021155724
19	Boston City Hosp / Pediatrics	Boston	Massachusetts	United States	02118
20	Univ of Massachusetts Med School	Worcester	Massachusetts	United States	016550001
21	Univ of Mississippi Med Ctr	Jackson	Mississippi	United States	39213
22	Univ of Medicine & Dentistry of New Jersey / Univ Hosp	Newark	New Jersey	United States	071032714
23	Children's Hosp at Albany Med Ctr	Albany	New York	United States	12208
24	Columbia Presbyterian Med Ctr	New York	New York	United States	10032
25	Harlem Hosp Ctr	New York	New York	United States	10037
26	Univ of Rochester Med Ctr	Rochester	New York	United States	146420001
27	State Univ of New York at Stony Brook	Stony Brook	New York	United States	117948111
28	SUNY Health Sciences Ctr at Syracuse / Pediatrics	Syracuse	New York	United States	13210
29	Westchester Hosp	Valhalla	New York	United States	10595
30	Duke Univ Med Ctr	Durham	North Carolina	United States	277103499
31	Med Univ of South Carolina	Charleston	South Carolina	United States	294253312
32	Children's Med Ctr of Dallas	Dallas	Texas	United States	75235
33	Children's Hosp of the King's Daughters	Norfolk	Virginia	United States	23507
34	Med College of Virginia	Richmond	Virginia	United States	23219
35	Children's Hospital & Medical Center / Seattle ACTU	Seattle	Washington	United States	981050371
36	Univ of Puerto Rico / Univ Children's Hosp AIDS	San Juan		Puerto Rico	009365067