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
ID00000942
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 2021-10-29
1244
Participants Needed
5
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 babies can help reduce the chance that a mother will give HIV to her baby during delivery. Previous studies suggest that NVP is a promising medication for blocking HIV transmission from HIV-positive mothers to their babies.
CONDITIONS
Official Title
A Study of Nevirapine to Prevent HIV Transmission From Mothers to Their Babies
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:
- Your baby will not live.
- You intend to breast-feed.
- You are allergic to benzodiazepines (a tranquilizer).
- You have a liver disorder.
- You have received non-nucleoside reverse transcriptase inhibitors (a class of anti-HIV drugs).
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: 5 locations
1
Hopital Hotel Dieu de Lyon
Lyon, France
Status Unknown
2
CHRU de Nantes
Nantes, France
Status Unknown
3
Universita Frederico II
Naples, Italy
Status Unknown
4
Hosp Doce De Octubre
Madrid, Spain
Status Unknown
5
Princess Margaret Hosp
Nassau, The Bahamas
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