Safety and Effectiveness of Ritonavir Plus Lamivudine Plus Zidovudine in HIV-Infected Pregnant Women and Their Babies
NCT ID: NCT00000888
Last Updated: 2021-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
14 participants
INTERVENTIONAL
2001-04-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Ritonavir
Lamivudine
Zidovudine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
13 Years
FEMALE
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Gwendolyn Scott
Role: STUDY_CHAIR
Univ of Miami (Pediatric)
Mary Jo O'Sullivan
Role: STUDY_CHAIR
Univ of Miami (Pediatric)
Locations
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Univ. of Miami Miller School of Medicine - Jackson Memorial Hosp.
Miami, Florida, United States
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, United States
Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, United States
Regional Med Ctr at Memphis
Memphis, Tennessee, United States
St. Jude/UTHSC CRS
Memphis, Tennessee, United States
Countries
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References
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Chadwick EG, Rodman JH, Britto P, Powell C, Palumbo P, Luzuriaga K, Hughes M, Abrams EJ, Flynn PM, Borkowsky W, Yogev R; PACTG Protocol 345 Team. Ritonavir-based highly active antiretroviral therapy in human immunodeficiency virus type 1-infected infants younger than 24 months of age. Pediatr Infect Dis J. 2005 Sep;24(9):793-800. doi: 10.1097/01.inf.0000177281.93658.df.
Other Identifiers
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10604
Identifier Type: REGISTRY
Identifier Source: secondary_id
PACTG 354
Identifier Type: -
Identifier Source: secondary_id
ACTG 354
Identifier Type: -
Identifier Source: org_study_id