Safety and Effectiveness of Ritonavir Plus Lamivudine Plus Zidovudine in HIV-Infected Pregnant Women and Their Babies
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Pregnancy
Intervention: Ritonavir (Drug); Lamivudine (Drug); Zidovudine (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
Gwendolyn Scott, Study Chair, Affiliation: Univ of Miami (Pediatric)
Mary Jo O'Sullivan, Study Chair, Affiliation: Univ of Miami (Pediatric)
Summary
The purpose of this study is to see if it is safe and effective to give ritonavir (RTV) plus
lamivudine (3TC) plus zidovudine (ZDV) to HIV-infected pregnant women during pregnancy and to
their babies after birth.
Pregnant women who are HIV-positive are at risk of giving HIV to their babies during
pregnancy or delivery. It is important to learn how to prevent HIV-positive pregnant women
from giving HIV to their babies. RTV and ZDV have been shown to be safe and effective against
HIV in adults. The combination of 3 anti-HIV drugs (RTV, 3TC, and ZDV) may help prevent HIV
infection from mother to infant but studies are needed to determine whether they are safe and
effective during pregnancy.
Clinical Details
Official title: A Phase I Trial of the Safety, Tolerance, and Pharmacokinetics of Oral Ritonavir Co-Administered With Lamivudine (3TC) and Zidovudine (ZDV) in HIV-1-Infected Pregnant Women and Their Infants
Study design: Treatment, Safety Study
Detailed description:
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.
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria
Women may be eligible for this study if they:
Are HIV-positive.
Are between 14 and 32 weeks pregnant.
Are at least 13 years old (consent of parent or guardian required if under 18).
Have the consent of the baby's father (if he can be reached).
Exclusion Criteria
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.
Locations and Contacts
Howard Univ Hosp, Washington, District of Columbia 20060, United States
Univ of Miami (Pediatric), Miami, Florida 33161, United States
Univ of Miami / Jackson Memorial Hosp, Miami, Florida 33136, United States
Tulane Univ / Charity Hosp of New Orleans, New Orleans, Louisiana 701122699, United States
Univ Hosp, New Orleans, Louisiana 70112, United States
Tulane Univ Hosp of New Orleans, New Orleans, Louisiana 701122699, United States
Children's Hosp of Michigan, Detroit, Michigan 48201, United States
Methodist Hosp Central, Memphis, Tennessee 381052794, United States
Saint Jude Children's Research Hosp of Memphis, Memphis, Tennessee 381052794, United States
Regional Med Ctr at Memphis, Memphis, Tennessee 38103, United States
Med College of Virginia, Richmond, Virginia 23219, United States
Children's Hospital & Medical Center / Seattle ACTU, Seattle, Washington 981050371, United States
Additional Information
Click here for more information about lamivudine Click here for more information about ritonavir Click here for more information about zidovudine Haga clic aquí para más información acerca del VIH y el embarazo Click here for more information on medication regimens for HIV positive pregnant women Click here for more information on medication safety during pregnancy Click here for more information on after birth care for HIV positive women and their babies Haga clic aquí para más información acerca del VIH y el embarazo Haga clic aquí para más información acerca de los tratamientos para las mujeres embarazadas infectadas por el VIH Haga clic aquí para más información acerca de la inocuidad de los medicamentos contra el VIH durante el embarazo Haga clic aquí para más información acerca del cuidado de las mujeres VIH positivas y sus bebés después del parto Haga clic aquí para ver información sobre este ensayo clínico en español.
Starting date: December 1997
Last updated: March 13, 2006
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