A Study of HIV Levels During Pregnancy and After Childbirth
A Prospective Observational Study of Virologic and Immunologic Changes in HIV-Infected Women During the Postpartum Period
The purpose of this study is to find out if HIV-infected pregnant women taking anti-HIV drugs have an increased amount of HIV in their blood (viral load) after having the baby.
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.
Przegląd badań
Status
Warunki
Szczegółowy opis
Limited data suggest that HIV-infected pregnant women develop postpartum viral rebound. However, viral load changes in the postpartum period have not been adequately characterized. Changes in adherence to antiretroviral therapy, pregnancy-related changes in pharmacokinetics of antiretroviral medications, and decline in immune competence are mechanisms by which postpartum viral load rebound may occur. This study is designed to characterize the incidence and magnitude of postpartum viral rebound during the initial 24 weeks postpartum and to explore the mechanisms and consequences of viral rebound.
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.
Typ studiów
Zapisy
Kontakty i lokalizacje
Lokalizacje studiów
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San Juan, Portoryko
- San Juan City Hosp
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Alabama
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Birmingham, Alabama, Stany Zjednoczone, 35294
- Univ of Alabama at Birmingham
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California
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Los Angeles, California, Stany Zjednoczone, 90095-1793
- UCLA School of Medicine
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Los Angeles, California, Stany Zjednoczone, 90033
- Los Angeles County Medical Center/USC
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San Diego, California, Stany Zjednoczone, 92103
- UCSD Mother, Child & Adolescent HIV Program
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San Francisco, California, Stany Zjednoczone, 94110
- San Francisco General Hosp
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Florida
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Jacksonville, Florida, Stany Zjednoczone, 32209
- Univ of Florida- Health Science Ctr
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Georgia
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Atlanta, Georgia, Stany Zjednoczone, 30308
- Emory Univ
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Hawaii
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Honolulu, Hawaii, Stany Zjednoczone, 98616-2396
- University of Hawaii
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Illinois
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Chicago, Illinois, Stany Zjednoczone, 60612
- Rush Presbyterian - Saint Luke's Med Ctr
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Chicago, Illinois, Stany Zjednoczone, 60611-3015
- Northwestern University
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Chicago, Illinois, Stany Zjednoczone, 60612
- Cook County Hosp Core Ctr
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Chicago, Illinois, Stany Zjednoczone, 60614
- Chicago Childrens Memorial Hospital (Pediatric)
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Indiana
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Indianapolis, Indiana, Stany Zjednoczone, 46202
- Indiana Univ Hosp
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Michigan
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Detroit, Michigan, Stany Zjednoczone, 48201
- Childrens Hospital of Michigan
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Detroit, Michigan, Stany Zjednoczone, 48201-1427
- Hutzel Hospital
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Minnesota
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Minneapolis, Minnesota, Stany Zjednoczone, 55455-0392
- Hennepin County Med Clinic
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New Jersey
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Newark, New Jersey, Stany Zjednoczone, 07103
- Univ of Med & Dentistry of NJ/Univ Hosp
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New York
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Bronx, New York, Stany Zjednoczone, 10461
- Jacobi Med Ctr
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New York, New York, Stany Zjednoczone, 10032-3784
- Columbia University
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New York,, New York, Stany Zjednoczone, 10016-6481
- NYU/Bellevue
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Stony Brook, New York, Stany Zjednoczone, 11794-8111
- State Univ of New York at Stony Brook
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North Carolina
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Chapel Hill, North Carolina, Stany Zjednoczone, 27514
- Univ of North Carolina
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Durham, North Carolina, Stany Zjednoczone, 27710
- Duke Univ Med Ctr
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Ohio
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Cleveland, Ohio, Stany Zjednoczone, 44106
- Case Western Reserve Univ
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Cleveland, Ohio, Stany Zjednoczone, 44109-1998
- MetroHealth Med Ctr
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Pennsylvania
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15213-2582
- University of Pittsburgh
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Rhode Island
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Providence, Rhode Island, Stany Zjednoczone, 02906
- Miriam Hosp / Brown Univ
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Tennessee
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Memphis, Tennessee, Stany Zjednoczone, 38105-2794
- The Regional Med Ctr, Memphis
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Nashville, Tennessee, Stany Zjednoczone, 37203
- Comprehensive Care Clinic
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Texas
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Dallas, Texas, Stany Zjednoczone, 75235-9173
- University of Texas, Southwestern Medical Center
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Washington
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Seattle, Washington, Stany Zjednoczone, 98104
- Univ of Washington (Seattle)
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria
Patients may be eligible for this study if they:
- 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
Patients may not be eligible for this study if they:
- 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.
Plan studiów
Jak projektuje się badanie?
Współpracownicy i badacze
Śledczy
- Krzesło do nauki: Beverly Sha
- Krzesło do nauki: Alice Stek
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Zakażenia wirusem RNA
- Choroby wirusowe
- Infekcje
- Infekcje przenoszone przez krew
- Choroby zakaźne
- Choroby przenoszone drogą płciową, wirusowe
- Choroby przenoszone drogą płciową
- Infekcje lentiwirusowe
- Zakażenia Retroviridae
- Zespoły niedoboru odporności
- Choroby układu odpornościowego
- Zakażenia wirusem HIV
Inne numery identyfikacyjne badania
- ACTG A5150
- ACTG A5153s
- AACTG A5150
- AACTG A5153s
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