The impact of race/ethnicity on mother-to-child HIV transmission in the United States in Pediatric AIDS Clinical Trials Group Protocol 316.
Coleen K Cunningham, Rajalakshmi Balasubramanian, Isaac Delke...
https://pubmed.ncbi.nlm.nih.gov/15213563Completed
Phase 3
Age: 13Years +
All Genders
ID00001135
A Phase III Randomized, Double-Blinded Study of Nevirapine for the Prevention of Maternal-Fetal Transmission in Pregnant HIV-Infected Women
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-01
2009
Participants Needed
20
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to see if giving the anti-HIV drug nevirapine (NVP) to HIV-positive pregnant women and their infants can help reduce the chance that a mother will give HIV to her baby during delivery. NVP is a promising medication for blocking HIV transmission from HIV-positive mothers to their infants. NVP is inexpensive and is easily absorbed by the mother and transferred to the infant. It is thought that even a single dose to the mother and infant may provide enough protection to the baby during the time of exposure to HIV at birth.
CONDITIONS
Official Title
A Study of Nevirapine to Prevent HIV Transmission From Mothers to Their Infants
Who Can Participate
Age: 13Years +
All Genders
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
You may be eligible for this study if you:
- Are an HIV-positive pregnant woman.
- Have been pregnant for at least 28 weeks.
- Are at least 13 years of age (consent of parent or guardian is required if under 18).
Exclusion Criteria
You will not be eligible for this study if:
- You intend to breast-feed.
- You are allergic to benzodiazepines (a type of tranquilizer).
- You have a liver disorder.
- You have received nonnucleoside reverse transcriptase inhibitors (NNRTIs), a class of anti-HIV drugs.
- You refuse to take ZDV.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 20 locations
1
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, United States, 35233
Status Unknown
2
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States, 920930672
Status Unknown
3
UCLA Med Ctr / Pediatric
Los Angeles, California, United States, 900951752
Status Unknown
4
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States, 941430105
Status Unknown
5
Children's Hosp of Washington DC
Washington D.C., District of Columbia, United States, 200102916
Status Unknown
6
Univ of Miami (Pediatric)
Miami, Florida, United States, 33161
Status Unknown
7
Chicago Children's Memorial Hosp
Chicago, Illinois, United States, 606143394
Status Unknown
8
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, United States, 701122699
Status Unknown
9
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, United States, 212874933
Status Unknown
10
Children's Hosp of Boston
Boston, Massachusetts, United States, 021155724
Status Unknown
11
Univ of Massachusetts Med School
Worcester, Massachusetts, United States, 016550001
Status Unknown
12
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States, 071032714
Status Unknown
13
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Status Unknown
14
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Status Unknown
15
Duke Univ Med Ctr
Durham, North Carolina, United States, 277103499
Status Unknown
16
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, United States, 191044318
Status Unknown
17
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, United States, 381052794
Status Unknown
18
Texas Children's Hosp / Baylor Univ
Houston, Texas, United States, 77030
Status Unknown
19
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States, 981050371
Status Unknown
20
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, Puerto Rico, 009365067
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
N/A
Model
N/A
Primary Purpose
PREVENTION
Number of Arms
0
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Published Research Related To This Trial
Maternal toxicity and pregnancy complications in human immunodeficiency virus-infected women receiving antiretroviral therapy: PACTG 316.
D Heather Watts, Rajalakshmi Balasubramanian, Robert T Maupin...
https://pubmed.ncbi.nlm.nih.gov/14981398