A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given With Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants
NCT ID: NCT00000887
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
24 participants
INTERVENTIONAL
2004-07-31
Brief Summary
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ZDV has been given to mothers in the past to reduce the chances of passing HIV on to their babies. However, better treatments are needed to further reduce these chances and to better suit the treatment needs of mothers and their children. Taking a combination of anti-HIV drugs during pregnancy may be an answer.
Detailed Description
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Women receive nelfinavir plus 3TC plus ZDV antepartum (Study Day 0 until onset of active labor) through postpartum (after cord clamped to 12 weeks). \[AS PER AMENDMENT 10/28/97: If patient presents in active labor with less than 1 hour to delivery time, the institutional protocol for ZDV infusion during labor should be followed.\] \[AS PER AMENDMENT 1/26/99: For maternal dosing, one Combivir tablet bid can be substituted for the individual formulation of 3TC and ZDV. For mothers who receive Combivir during the antepartum period, Combivir is held during labor and delivery, and the separate formulations of ZDV and 3TC are used. Patients who prematurely discontinue study treatment should continue to be followed on study for the duration of the study.\] Full pharmacokinetic sampling is performed 10 to 15 days after start of therapy \[AS PER AMENDMENT 2/7/00: 10 to 15 days after study entry for women currently taking nelfinavir\] and again 5 to 6 weeks after delivery. A maternal blood sample and cord blood sample is collected at birth for analysis of nelfinavir concentrations. Maternal HIV RNA in plasma is monitored throughout the study. Cervicovaginal secretions are collected at entry, late gestation, and postpartum to assess the presence of HIV. A single pharmacokinetics sample is collected with each cervicovaginal secretion. Serial CD4/CD8 activation markers are measured in women during gestation and postpartum. Infants receive nelfinavir plus 3TC plus ZDV beginning approximately 12 hours following birth and continuing for 6 weeks. After birth, several blood samples are collected from the infant for determination of washout kinetics of nelfinavir. Full pharmacokinetics sampling is performed 5 to 8 days post birth and 5 to 6 weeks following multiple doses. Pharmacokinetic samples are analyzed on the first six mother-infant pairs and dosing may be adjusted accordingly for the next cohort. Agouron has agreed to make nelfinavir available to all interested study participants for a period of 6 months after the study via the patient assistance program.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Nelfinavir mesylate
Lamivudine
Zidovudine
Eligibility Criteria
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Inclusion Criteria
* Are at least 13 years old (need consent of parent or guardian if under 18).
* Are HIV-positive.
* Are in the 2nd or 3rd trimester (14 to 34 weeks pregnant) and are pregnant with one or two children.
* Have a normal ultrasound exam.
Exclusion Criteria
* Cannot take ZDV or 3TC.
* Have an active opportunistic (HIV-associated) or bacterial infection, or a severe medical condition.
* Have severe diarrhea.
* Are at risk for premature birth or pregnancy complications.
* Have a family history of phenylketonuria (PKU).
* Plan to breast-feed.
* Abuse alcohol or drugs.
* Cannot visit the same clinic for the duration of the study.
* Have taken certain anti-HIV drugs.
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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Yvonne Bryson
Role: STUDY_CHAIR
Mark Mirochnick
Role: STUDY_CHAIR
Alice Stek
Role: STUDY_CHAIR
Locations
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Usc La Nichd Crs
Los Angeles, California, United States
Tulane Univ. Health Science Ctr., Tulane Univ. Hosp. & Clinic
New Orleans, Louisiana, United States
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States
UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
Chapel Hill, North Carolina, United States
St. Christopher's Hosp. for Children
Philadelphia, Pennsylvania, United States
Countries
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References
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Bryson Y, Stek A, Mirochnick M, et al. Pharmacokinetics, antiviral activity, and safety of nelfinavir (NFV) with ZDV/3TC in pregnant HIV-infected women and their infants. PACTG 353 cohort 2. 9th Conference on Retroviruses and Opportunistic Infections. 2002, February 24-28; Seattle Washington (abstract no 795)
Bryson YJ, Mirochnick M, Stek A, Mofenson LM, Connor J, Capparelli E, Watts DH, Huang S, Hughes MD, Kaiser K, Purdue L, Asfaw Y, Keller M, Smith E; PACTG 353 Team. Pharmacokinetics and safety of nelfinavir when used in combination with zidovudine and lamivudine in HIV-infected pregnant women: Pediatric AIDS Clinical Trials Group (PACTG) Protocol 353. HIV Clin Trials. 2008 Mar-Apr;9(2):115-25. doi: 10.1310/hct0902-115.
Other Identifiers
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10603
Identifier Type: REGISTRY
Identifier Source: secondary_id
PACTG 353
Identifier Type: -
Identifier Source: secondary_id
ACTG 353
Identifier Type: -
Identifier Source: org_study_id