Completed
A Phase I Trial of the Pharmacokinetics and Tolerance of Oral Zidovudine Administered to HIV-1 Infected Pregnant Women During Labor and Delivery
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-28
36
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
To obtain a pharmacokinetic profile of oral ZDV and to determine whether the oral administration of Zidovudine (ZDV) during labor and delivery will provide a similar profile to that obtained with the use of IV ZDV in ACTG 082. To evaluate the tolerance of oral ZDV in this population, defined as the ability to take oral doses and lack of vomiting within 30 minutes of receiving oral study doses. The worldwide use of constant intrapartum ZDV infusions to prevent transmission is not practical or feasible. Approximately 18% of the women in the ACTG 076 trial missed their IV ZDV infusions, even at experienced ACTG sites. There is an urgent need to establish a more practical method of delivering ZDV during labor and delivery that, at minimum, will approximate the rate of ZDV administration utilized in ACTG 082. In the future, this would enable women to start an intensive ZDV regimen during early labor, even prior to reaching the hospital.
CONDITIONS
Official Title
A Study of Zidovudine During Labor and Delivery in HIV-Infected Pregnant Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
A woman may be eligible for this study if:
- She is HIV-positive.
- She is at least 34 weeks pregnant.
- She has a history of at least 4 weeks of continuous oral ZDV during her current pregnancy and tolerated it well.
- She has given consent for her newborn to participate in this study. (The father must also give consent if he is available after reasonable attempts to contact him. A woman under 18 needs the consent of a parent or legal guardian for her and her infant to participate.)
Exclusion Criteria
A woman will not be eligible for this study if:
- She is taking part in another study of HIV treatment during pregnancy.
- Her infant has a life-threatening illness indicated in an ultrasound.
- Her infant does not appear to be growing normally in the womb.
- She has a cesarean section.
- She has abnormal blood test results.
- She has severe nausea, vomiting, or other problems of the stomach and intestines at the time of study entry.
- She has an active opportunistic (AIDS-related) infection or other serious infection at the time of study entry.
- The study staff cannot find a usable vein.
- The study doctor feels that she cannot take drugs by mouth.
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: 11 locations
1
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States, 920930672
Status Unknown
2
UCLA Med Ctr / Pediatric
Los Angeles, California, United States, 900951752
Status Unknown
3
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States, 941430105
Status Unknown
4
Univ of California, San Francisco
San Francisco, California, United States, 94143
Status Unknown
5
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States, 32209
Status Unknown
6
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, United States, 33136
Status Unknown
7
Univ of Miami (Pediatric)
Miami, Florida, United States, 33161
Status Unknown
8
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States, 071032714
Status Unknown
9
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, United States, 381052794
Status Unknown
10
Children's Hosp of the King's Daughters
Norfolk, Virginia, United States, 23507
Status Unknown
11
San Juan City Hosp
San Juan, Puerto Rico, 009367344
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
0
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