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
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.
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.]
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.