Completed

A Study of Zidovudine During Labor and Delivery in HIV-Infected Pregnant Women

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What is being tested

Zidovudine

Drug
Who is being recruted

HIV Infections

+ Pregnancy
How is the trial designed

Treatment Study

Phase 1
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: October 28, 2021
Sourced from a government-validated database.Claim as a partner

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: \[AS PER AMENDMENT 08/03/01: Women in active labor receive initial loading dose of oral ZDV, then another dose of oral ZDV 3 hours later, both doses followed by PK sampling. After PK sampling post second oral dose, or at 8 cm dilation (whichever comes first), woman receives IV ZDV until delivery. The cord blood will not be analyzed for serum ZDV PK levels and the infant's infection status will be determined.\]

Official TitleA Phase I Trial of the Pharmacokinetics and Tolerance of Oral Zidovudine Administered to HIV-1 Infected Pregnant Women During Labor and Delivery 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: October 28, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
36 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
Pregnancy
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.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 11 locations
Suspended
UCSD Med Ctr / Pediatrics / Clinical SciencesLa Jolla, United StatesSee the location
Suspended
UCLA Med Ctr / PediatricLos Angeles, United States
Suspended
UCSF / Moffitt Hosp - PediatricSan Francisco, United States
Suspended
Univ of California, San FranciscoSan Francisco, United States

Completed11 Study Centers