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Ensayos clínicos

Ensayos clínicos

Safety and Effectiveness of Ritonavir Plus Lamivudine Plus Zidovudine in HIV-Infected Pregnant Women and Their Babies

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00000888, ACTG 354
  • Concluido

Propósito del estudio

To assess the pharmacokinetics, safety, and tolerance of ritonavir (RTV) when given in combination with lamivudine (3TC) and zidovudine (ZDV) to HIV-1-infected pregnant women. To assess the safety and tolerance of prior maternal dosing in the newborn. To assess the pharmacokinetics of ritonavir in cord blood and neonatal samples following maternal dosing. To determine an initial dosage regimen of ritonavir for infants up to 6 weeks of age. [AS PER AMENDMENT 2/9/99: To determine an initial dosage regimen of ritonavir for infants up to 4 weeks of age.]

Afección:Fase:
Infecciones por el VIH
Embarazo
Fase 1

Detalles del estudio

Controlled studies of the pharmacokinetics and safety of new drugs are critical to the development of alternative therapies for the prevention of perinatal transmission of HIV-1. The dosing regimen of RTV and ZDV used to treat pregnant women in this study has been shown to be safe and effective against HIV in adults. Little is known about the metabolism and tolerance of these drugs during pregnancy, and Phase I studies are needed to determine dosage, safety, and tolerance. Protease inhibitors in combination with other antiretroviral drugs may help reduce the rate of perinatal transmission of HIV-1.Pregnant women start with RTV (increasing gradually over a few days) plus 3TC plus ZDV until active labor. Intrapartum, women receive RTV plus 3TC plus ZDV, then postpartum (after cord clamped until 12 weeks postpartum), RTV plus 3TC plus ZDV. [AS PER AMENDMENT 2/9/99: For maternal dosing, one Combivir tablet (containing 3TC and ZDV) may be administered in place of the individual agents 3TC and ZDV. During the intrapartum period, Combivir is held and the patient follows intrapartum 3TC/ZDV dosing. During the intrapartum period, no RTV is given after the onset of active labor. During the postpartum period, RTV is begun as soon as oral intake is allowable following delivery. During the postpartum period, Combivir may be resumed. All subjects who prematurely discontinue study treatment should continue to be followed for the duration of the study.] [AS PER AMENDMENT 9/28/99: During the intrapartum period, RTV is given at the start of active labor.] Infants begin 3TC and ZDV as soon as oral intake is tolerated. Infants participate in one of two cohorts. The first four infants delivered (Cohort 1) receive RTV as a single dose between Days 8 and 12. The next six infants delivered (Cohort 2) start RTV at 2-3 days of life. The dosing schedule is based on Cohort 1 drug pharmacokinetics data. [AS PER AMENDMENT 2/9/99: Cohort 1 is expanded to seven mother/infant pairs.] [AS PER AMENDMENT 9/28/99: Cohort 1 is expanded to eight mother/infant pairs.] Both maternal and infant blood is drawn to assess drug pharmacokinetics. Cervical secretions are collected to assess presence of virus. In addition, all placentas are examined by histopathology to determine the role of placenta on preterm delivery in women receiving combination antiretroviral therapy.

Criterios de exclusión

    Women will not be eligible for this study if they: Are having problems with their pregnancy. Have a history of problem pregnancies including miscarriages, birth defects, stillbirths, or giving birth to premature or low-birth-weight babies. Have had side effects to ZDV, 3TC, or RTV. Have an active opportunistic (AIDS-related) or other serious infection. Have other serious conditions such as heart or lung problems, blood disorders, diabetes, or seizures. Are pregnant with more than one baby (such as twins or triplets). Are taking other experimental medications. Are taking other anti-HIV medications. Are taking certain other medications including those for cancer, blood pressure, or seizures. Are abusing drugs or alcohol. Are breast-feeding.

Centros de estudio/contactos

Florida

    Univ. of Miami Ped. Perinatal HIV/AIDS CRS, Miami, Florida, 33161, United States

    Univ. of Miami Miller School of Medicine - Jackson Memorial Hosp., Miami, Florida, 33136, United States

Michigan

    Children's Hospital of Michigan NICHD CRS, Detroit, Michigan, 48201, United States

Tennessee

    Regional Med Ctr at Memphis, Memphis, Tennessee, 38103, United States

    St. Jude/UTHSC CRS, Memphis, Tennessee, 38105, United States

Actualizado: 13 de octubre del 2004

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