Terminé

A Phase I Trial To Evaluate Zidovudine (ZDV) in HIV-1 Infected Pregnant Women and Their Offspring

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Ce qui est testé

Collecte de données

Qui peut participer

Infections transmises par le sang+18

+ Maladies génito-urinaires

+ Maladies Génitales

Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Phase 1
Interventionnel
Voir le détail du protocole

Résumé

Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

An estimated 30 percent to 40 percent infected pregnant women risk transmission of HIV-1 to their infants, whether they be symptomatic or asymptomatic. Zidovudine (AZT) has previously demonstrated its effectiveness as a potent inhibitor of HIV replication in vitro and in adult patients; benefits of treatment include decreased mortality rate, decreased incidence of opportunistic infections, and increased number of CD4 cells. Phase I AZT studies in children, however, have resulted in uncontrolled information regarding clinical efficacy. The present study, therefore, will investigate the safety and pharmacokinetics of intravenous (IV) and oral AZT administration to HIV-1 infected pregnant women in the 3rd trimester, as well as the safety and efficacy of such treatment in their newborns. It is hoped that the results will be instrumental in designing future studies to assess the efficacy of AZT in reducing the transmission risk of HIV-1. AMENDED: For the pharmacokinetic and safety study of AZT during labor and in the newborn infants, women who were screened and have consented are included in this part of the study. 6 mother-infant pairs without a history of intravenous drug abuse and 4 pairs with such a history are evaluated. The mother receives an infusion of AZT over 1 hour followed by continuous infusion of AZT for at least 4 hours until delivery. Pharmacokinetic data is collected on all patients including those who deliver before receiving 4 hours of AZT infusion. AMENDED: The trial will proceed as described above except that the first 2 methadone patients enrolled will receive half the AZT dose given to the non-methadone patients. Results will be evaluated before dosing of additional methadone-use patients is done. Original design: Following evaluation, patients receive one intravenous dose of AZT over a 1-hour period. One day later, patients begin taking AZT capsules 5 times a day by mouth for the remaining weeks prior to labor. During labor, patients continue to receive AZT intravenously every 4 hours until they deliver their babies. Blood and urine tests are made to measure the amounts of AZT in the mother's and, after delivery, the baby's body fluids. AZT is stopped after the baby has been delivered. The initial enrollment is six women with no history of intravenous drug abuse plus another four women with a history of intravenous drug use, who have been receiving methadone maintenance therapy. These women are not required to have a negative urine toxicology screen for illicit drugs to enter the study.

Titre officielA Phase I Trial To Evaluate Zidovudine (ZDV) in HIV-1 Infected Pregnant Women and Their Offspring
NCT00001106
Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

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

40 participants à inclure

Nombre 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.

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

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Infections transmises par le sangMaladies génito-urinairesMaladies GénitalesSyndrome d'Immunodéficience AcquiseMaladies TransmissiblesMaladies urogénitales féminines et complications de la grossesseSyndromes de Déficience ImmunologiqueMaladies du Système ImmunitaireInfectionsComplications de la grossesseComplications infectieuses de la grossesseEffets Retardés de l'Exposition PrénataleInfections à RetroviridaeInfections à virus ARNMaladies Sexuellement TransmissiblesMaladies à virus lentMaladies viralesMaladies Sexuellement Transmissibles ViralesInfections à VIHInfections à LentivirusBlessures prénatales

Critères

Inclusion Criteria Concurrent Medication: Allowed: * In one group of four or more patients, methadone maintenance treatment. * Acetaminophen for periods less than 72 hours. * Supportive therapy including blood and blood products, vaginal creams, antiemetics, antidiarrheals, and cough medicines as deemed necessary by the responsible investigator. * Iron, multivitamins, and short course of treatment for correctable medical problems, such as urinary tract infection. Concurrent Treatment: Allowed: * Blood and blood products as supportive therapy. Patients must have HIV-1 infection and be in the third trimester of pregnancy. Additional patients will also be receiving methadone maintenance therapy for intravenous drug use. Exclusion Criteria Concurrent Medication: Excluded: * Systemic medications during this pregnancy. * Acetaminophen for periods more than 72 hours. Patients will be excluded from the study for the following reasons: * Complications of pregnancy. * History of poor medical compliance related to factors other than accessibility of care. * Insistence on breast-feeding during the first 24 hours of the birth of the child. * Evidence of preexisting fetal anomalies at = or \> 20 weeks gestation as noted by an abnormal level 2 sonogram prior to study entry. * Evidence of fetal intolerance of the intrauterine environment including intrauterine growth retardation, oligohydramnios, polyhydramnios, biophysical profile equal to or less than 6 for fetus with a gestational age \> 32 weeks, congenital malformation, fetal hydrous or ascites. * Previous systemic infection including influenza during this pregnancy. * Malabsorption syndrome and/or history of frequent diarrhea that might interfere with absorption of oral zidovudine (AZT). Prior Medication: Excluded: * Antivirals and other systemic medications during this pregnancy. Patients may not have any of the following diseases or symptoms: * Obstetrical complications: * Poor obstetrical history including but not limited to recurrent spontaneous abortions, previous preterm or low-birth-weight infant, congenital anomalies (past or present pregnancy), premature rupture of membranes, multiple gestation, intrauterine fetal death (this pregnancy), and placenta previa or abruptio (this pregnancy). * Medical complications: * Conditions including but not limited to insulin-dependent diabetes mellitus (IDDM), hypertensive disorders which include preeclampsia, eclampsia, chronic hypertension, cardiovascular disease including rheumatic or congenital heart disease, collagen vascular disease, endocarditis, and renal disease. * Hematologic complications. * Neurologic complications. * Pulmonary complications. History of illicit drug use during this pregnancy. * Note: This exclusion applies only to the first six or more women to enter this study who do not have a history of intravenous drug use. Four or more patients: * Intravenous drug use, if enrolled in a methadone maintenance program.

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 9 sites

Suspendu

Kaiser - Edgemont Street / UCLA Med Ctr

Los Angeles, United StatesOuvrir Kaiser - Edgemont Street / UCLA Med Ctr dans Google Maps
Suspendu

UCLA Med Ctr / Pediatric

Los Angeles, United States
Suspendu

Univ of Miami (Pediatric)

Miami, United States
Suspendu

Boston City Hosp / Pediatrics

Boston, United States
Terminé9 Centres d'Étude
A Phase I Trial To Evaluate Zidovudine (ZDV) in HIV-1 Infected Pregnant Women and Their Offspring | PatLynk