A Study of HIV Levels During Pregnancy and After Childbirth
NCT ID: NCT00041964
Last Updated: 2012-07-24
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
129 participants
OBSERVATIONAL
Brief Summary
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The purpose of A5153s, a substudy of A5150, is to characterize two anti-HIV drugs (nelfinavir \[NFV\] and lopinavir/ritonavir \[LPV/r\]) in HIV-infected women during pregnancy and after childbirth.
Sometimes pregnant women have an increase in their HIV viral load after their baby is born. This study will try to find out how often this happens. It will also examine possible reasons why the increase in viral load occurs.
Detailed Description
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Eligible patients are evaluated at gestational weeks 34 and 36, at delivery, and at regular visits for 96 weeks postpartum. Most evaluations include a medical history, physical exam, laboratory tests, and adherence and quality-of-life questionnaires. Viral load and CD4/CD8 cell counts are measured frequently.
Patients are expected to receive at least 8 weeks of stable HAART before delivery, and to continue HAART throughout the remainder of the study. The choice of HAART is left to the primary provider. No antiretroviral drugs are provided by this study.
Patients participating in the A5153s substudy receive either NFV or LPV/r as part of their HAART. Pharmacokinetic blood sampling takes place at 36 weeks gestation, 6 weeks postpartum, and 24 weeks postpartum. Patients record the administration times and doses of their NFV or LPV/r for 48 hours prior to each substudy visit, and hold their regularly scheduled doses of antiretroviral medications on substudy days. Patients arrive at the clinic fasting (no food or drink for the previous 8 hours) and are given a standardized breakfast prior to supervised administration of their NFV or LPV/r dose. An intravenous catheter is placed in an arm vein for blood collection at pre-dose and 1, 2, 4, and 6 hours post-dose.
Conditions
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Keywords
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Eligibility Criteria
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Inclusion Criteria
* Are age 13 or older.
* Are between 22 and 30 weeks pregnant.
* Have had their pregnancy confirmed by ultrasound at 14 weeks gestation or later.
* Are infected with HIV.
* Are planning to receive at least 8 weeks of highly active antiretroviral therapy (HAART) by the time they have their baby.
* Are available for follow-up for the duration of the study.
Exclusion Criteria
* Intend to terminate their pregnancy.
* Intend to breast-feed their baby.
* Are carrying a baby with major abnormalities, including spina bifida, anencephaly, hydrops, or ascites.
* Have taken certain medications.
* Are enrolled in other studies that require large blood draws.
* Will be taking anti-HIV drugs only to prevent mother-to-child transmission of HIV, and not to treat the maternal infection itself.
* Actively abuse drugs or alcohol in a way that would interfere with participation in the study.
13 Years
FEMALE
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Beverly Sha
Role: STUDY_CHAIR
Alice Stek
Role: STUDY_CHAIR
Locations
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Univ of Alabama at Birmingham
Birmingham, Alabama, United States
Los Angeles County Medical Center/USC
Los Angeles, California, United States
UCLA School of Medicine
Los Angeles, California, United States
UCSD Mother, Child & Adolescent HIV Program
San Diego, California, United States
San Francisco General Hosp
San Francisco, California, United States
Univ of Florida- Health Science Ctr
Jacksonville, Florida, United States
Emory Univ
Atlanta, Georgia, United States
University of Hawaii
Honolulu, Hawaii, United States
Northwestern University
Chicago, Illinois, United States
Cook County Hosp Core Ctr
Chicago, Illinois, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States
Chicago Childrens Memorial Hospital (Pediatric)
Chicago, Illinois, United States
Indiana Univ Hosp
Indianapolis, Indiana, United States
Hutzel Hospital
Detroit, Michigan, United States
Childrens Hospital of Michigan
Detroit, Michigan, United States
Hennepin County Med Clinic
Minneapolis, Minnesota, United States
Univ of Med & Dentistry of NJ/Univ Hosp
Newark, New Jersey, United States
NYU/Bellevue
New York, New York, United States
Columbia University
New York, New York, United States
State Univ of New York at Stony Brook
Stony Brook, New York, United States
Jacobi Med Ctr
The Bronx, New York, United States
Univ of North Carolina
Chapel Hill, North Carolina, United States
Duke Univ Med Ctr
Durham, North Carolina, United States
Case Western Reserve Univ
Cleveland, Ohio, United States
MetroHealth Med Ctr
Cleveland, Ohio, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Miriam Hosp / Brown Univ
Providence, Rhode Island, United States
The Regional Med Ctr, Memphis
Memphis, Tennessee, United States
Comprehensive Care Clinic
Nashville, Tennessee, United States
University of Texas, Southwestern Medical Center
Dallas, Texas, United States
Univ of Washington (Seattle)
Seattle, Washington, United States
San Juan City Hosp
San Juan, , Puerto Rico
Countries
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References
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Melvin AJ, Burchett SK, Watts DH, Hitti J, Hughes JP, McLellan CL, King PD, Johnson EJ, Williams BL, Frenkel LM, Coombs RW. Effect of pregnancy and zidovudine therapy on viral load in HIV-1-infected women. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Mar 1;14(3):232-6. doi: 10.1097/00042560-199703010-00006.
Rich KC, Siegel JN, Jennings C, Rydman RJ, Landay AL. CD4+ lymphocytes in perinatal human immunodeficiency virus (HIV) infection: evidence for pregnancy-induced immune depression in uninfected and HIV-infected women. J Infect Dis. 1995 Nov;172(5):1221-7. doi: 10.1093/infdis/172.5.1221.
Cao Y, Krogstad P, Korber BT, Koup RA, Muldoon M, Macken C, Song JL, Jin Z, Zhao JQ, Clapp S, Chen IS, Ho DD, Ammann AJ. Maternal HIV-1 viral load and vertical transmission of infection: the Ariel Project for the prevention of HIV transmission from mother to infant. Nat Med. 1997 May;3(5):549-52. doi: 10.1038/nm0597-549.
Burns DN, Landesman S, Minkoff H, Wright DJ, Waters D, Mitchell RM, Rubinstein A, Willoughby A, Goedert JJ. The influence of pregnancy on human immunodeficiency virus type 1 infection: antepartum and postpartum changes in human immunodeficiency virus type 1 viral load. Am J Obstet Gynecol. 1998 Feb;178(2):355-9. doi: 10.1016/s0002-9378(98)80025-2.
Sha BE, Tierney C, Cohn SE, Sun X, Coombs RW, Frenkel LM, Kalams SA, Aweeka FT, Bastow B, Bardeguez A, Kmack A, Stek A; Aids Clinical Trials Group ACTG A5150 Team. Postpartum viral load rebound in HIV-1-infected women treated with highly active antiretroviral therapy: AIDS Clinical Trials Group Protocol A5150. HIV Clin Trials. 2011 Jan-Feb;12(1):9-23. doi: 10.1310/hct1201-9.
Other Identifiers
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ACTG A5153s
Identifier Type: -
Identifier Source: secondary_id
AACTG A5150
Identifier Type: -
Identifier Source: secondary_id
AACTG A5153s
Identifier Type: -
Identifier Source: secondary_id
ACTG A5150
Identifier Type: -
Identifier Source: org_study_id