Terminé

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

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Ce qui est testé

Zidovudine

Médicament
Qui peut participer

HIV Infections

+ Pregnancy
Comment se déroule l'étude

Étude thérapeutique

Phase 1
Interventionnel

Résumé

Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 28 octobre 2021
Issu d'une base de données validée par les autorités. Revendiquer cette étude

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

Titre officielA Phase I Trial of the Pharmacokinetics and Tolerance of Oral Zidovudine Administered to HIV-1 Infected Pregnant Women During Labor and Delivery 
Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 28 octobre 2021
Issu d'une base de données validée par les autorités. Revendiquer cette étude

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design
36 participants à inclureNombre total de participants que l'essai clinique vise à recruter.
Traitement
Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.

Comment les traitements sont administrés aux participants
Les participants sont répartis en groupes distincts, chaque groupe recevant un traitement différent en même temps. Cela permet de comparer directement l'efficacité de plusieurs traitements.

Autres façons d'administrer les traitements
Groupe unique
: tous les participants reçoivent le même traitement.

Affectation croisée
: les participants passent d'un traitement à un autre au cours de l'étude.

Plan factoriel
: les participants reçoivent des combinaisons de traitements pour évaluer leurs interactions.

Plan séquentiel
: les traitements sont administrés successivement selon un ordre prédéterminé, pouvant varier selon la réaction du participant.

Autre type d'attribution
: L'attribution des traitements ne suit pas de schéma standard ni de protocole prédéfini.

Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères
FemmeLe sexe biologique des participants éligibles à s'inscrire.
Volontaires sains non autorisésIndique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.
Conditions
Pathologie
HIV Infections
Pregnancy
Critères

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.



Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.
Cette étude comporte 11 sites
Suspendu
UCSD Med Ctr / Pediatrics / Clinical SciencesLa Jolla, United StatesVoir le site
Suspendu
UCLA Med Ctr / PediatricLos Angeles, United States
Suspendu
UCSF / Moffitt Hosp - PediatricSan Francisco, United States
Suspendu
Univ of California, San FranciscoSan Francisco, United States

Terminé11 Centres d'Étude