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A Study to Evaluate the Safety and Tolerability of Zidovudine (ZDV) in Premature Infants Born to HIV-Positive Women. Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on A Study to Evaluate the Safety and Tolerability of Zidovudine (ZDV) in Premature Infants Born to HIV-Positive Women. conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Study to Evaluate the Safety and Tolerability of Zidovudine (ZDV) in Premature Infants Born to HIV-Positive Women. Clinical research trials and A Study to Evaluate the Safety and Tolerability of Zidovudine (ZDV) in Premature Infants Born to HIV-Positive Women. healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like A Study to Evaluate the Safety and Tolerability of Zidovudine (ZDV) in Premature Infants Born to HIV-Positive Women.. A Study to Evaluate the Safety and Tolerability of Zidovudine (ZDV) in Premature Infants Born to HIV-Positive Women. Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Study to Evaluate the Safety and Tolerability of Zidovudine (ZDV) in Premature Infants Born to HIV-Positive Women. clinical trial. Human subjects often obtain the finest healthcare possible for their A Study to Evaluate the Safety and Tolerability of Zidovudine (ZDV) in Premature Infants Born to HIV-Positive Women. condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.

Home > "A" Clinical Trials Conditions > A Study to Evaluate the Safety and Tolerability of Zidovudine (ZDV) in Premature Infants Born to HIV-Positive Women.

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



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

For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: /5 Days
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 35

Location and Contact Information:

Overall Study Official:
MirochnickM,  Study Chair, 

Univ of Massachusetts Med School
Worcester,  Massachusetts,  016550001
United States
 

Children's Hosp of the King's Daughters
Norfolk,  Virginia,  23507
United States
 

Westchester Hosp
Valhalla,  New York,  10595
United States
 

Columbia Presbyterian Med Ctr
New York City,  New York,  10032
United States
 

UCLA Med Ctr / Pediatric
Los Angeles,  California,  900951752
United States
 

Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis,  Indiana,  46202
United States
 

Med Univ of South Carolina
Charleston,  South Carolina,  294253312
United States
 

Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles,  California,  905022004
United States
 

Univ of Rochester Med Ctr
Rochester,  New York,  146420001
United States
 

Children's Hosp of Boston
Boston,  Massachusetts,  021155724
United States
 

Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan,  ,  009365067
Puerto Rico
 

Univ of Miami / Jackson Memorial Hosp
Miami,  Florida,  33136
United States
 

Boston City Hosp / Pediatrics
Boston,  Massachusetts,  02118
United States
 

State Univ of New York at Stony Brook
Stony Brook,  New York,  117948111
United States
 

Univ of Chicago Children's Hosp
Chicago,  Illinois,  606371470
United States
 

Univ of Miami (Pediatric)
Miami,  Florida,  33161
United States
 

Children's Hosp at Albany Med Ctr
Albany,  New York,  12208
United States
 

San Francisco Gen Hosp
San Francisco,  California,  94110
United States
 

Children's Hospital & Medical Center / Seattle ACTU
Seattle,  Washington,  981050371
United States
 

SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse,  New York,  13210
United States
 

Harlem Hosp Ctr
New York City,  New York,  10037
United States
 

Children's Med Ctr of Dallas
Dallas,  Texas,  75235
United States
 

Univ of Illinois College of Medicine / Pediatrics
Chicago,  Illinois,  60612
United States
 

Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark,  New Jersey,  071032714
United States
 

UCSF / Moffitt Hosp - Pediatric
San Francisco,  California,  941430105
United States
 

Duke Univ Med Ctr
Durham,  North Carolina,  277103499
United States
 

Med College of Virginia
Richmond,  Virginia,  23219
United States
 

Emory Univ Hosp / Pediatrics
Atlanta,  Georgia,  30306
United States
 

UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla,  California,  920930672
United States
 

Univ of Florida Health Science Ctr / Pediatrics
Jacksonville,  Florida,  32209
United States
 

Univ of Florida Gainesville
Gainesville,  Florida,  32610
United States
 

Children's Hosp of Oakland
Oakland,  California,  946091809
United States
 

Los Angeles County - USC Med Ctr
Los Angeles,  California,  90033
United States
 

Phoenix Childrens Hosp
Phoenix,  Arizona,  85006
United States
 

Univ of Alabama at Birmingham - Pediatric
Birmingham,  Alabama,  35233
United States
 

Univ of Mississippi Med Ctr
Jackson,  Mississippi,  39213
United States
 


Additional Information:
Study ID Numbers:
  ACTG 331; 
Study Start Date: 
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000855

Other Hiv Infections Studies:
1. Evaluation of Patients Who Have Not Had Success with Zidovudine

2. The Safety and Effectiveness of Two Forms of Saquinavir Combined with Other Anti-HIV Drugs in HIV-Infected Infants and Children

3. A Study of Zidovudine Plus Interleukin-2 in HIV-Infected Patients Who Have No Symptoms of Infection But Who Have Tender Lymph Nodes

4. The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients with HIV and Cryptococcal Meningitis

5. A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Adult Volunteers

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

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