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Home > "A" Clinical Trials Conditions > A Study of Zidovudine During Labor and Delivery in HIV-Infected Pregnant Women  A Study of Zidovudine During Labor and Delivery in HIV-Infected Pregnant Women
A Study of Zidovudine During Labor and Delivery in HIV-Infected Pregnant Women
For Condition: HIV Infections,Pregnancy
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: 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.
Details: 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. Cohort 1: Women in active labor receive 3 doses of oral ZDV 3 hours apart followed by PK sampling. After PK sampling post 3rd oral dose, or at 8 cm dilation (whichever comes first), women receive IV ZDV until delivery. The cord blood will be analyzed for serum ZDV PK levels and the infant's infection status will be determined. If the dose of ZDV is adequate to achieve targeted maternal serum drug levels in Cohort 1 and if oral dosing is tolerated in this cohort, Cohort 2 will begin enrollment. [AS PER AMENDMENT 08/03/01: Cohort 1 has been completed and only Cohort 2 is open for enrollment.] Cohort 2: [AS PER AMENDMENT 08/03/01: Women in active labor receive initial loading dose of oral ZDV, then another dose of oral ZDV 3 hours later, both doses followed by PK sampling. After PK sampling post second oral dose, or at 8 cm dilation (whichever comes first), woman receives IV ZDV until delivery. The cord blood will not be analyzed for serum ZDV PK levels and the infant's infection status will be determined.]
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Pharmacokinetics Study
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: 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.
Total Enrollment: 36
Location and Contact Information:
Overall Study Official:
MarkMirochnick, Study Chair,
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Univ of California, San Francisco
San Francisco, California, 94143
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Children's Hosp of the King's Daughters
Norfolk, Virginia, 23507
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, 33136
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Additional Information:
Study ID Numbers: PACTG 324;
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000862
Other Pregnancy Studies:
1. A Randomized, Comparative, Prospective Study of Daily Trimethoprim / Sulfamethoxazole (TMS) and Thrice-Weekly TMS for Prophylaxis Against PCP in HIV-Infected Patients
2. A Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
3. Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir)
4. Phase I Study of Alferon N Injection in Persons With Asymptomatic Human Immunodeficiency Virus (HIV) Infection
5. A Study to Test the Safety of Recombinant Interleukin-2 (rIL-2) in HIV-Infected Children
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A Study of Zidovudine During Labor and Delivery in HIV-Infected Pregnant Women
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