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.
調査の概要
詳細な説明
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.
研究の種類
入学
連絡先と場所
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35294
- Univ of Alabama at Birmingham
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California
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Los Angeles、California、アメリカ、90095-1793
- UCLA School of Medicine
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Los Angeles、California、アメリカ、90033
- Los Angeles County Medical Center/USC
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San Diego、California、アメリカ、92103
- UCSD Mother, Child & Adolescent HIV Program
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San Francisco、California、アメリカ、94110
- San Francisco General Hosp
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Florida
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Jacksonville、Florida、アメリカ、32209
- Univ of Florida- Health Science Ctr
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Georgia
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Atlanta、Georgia、アメリカ、30308
- Emory Univ
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Hawaii
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Honolulu、Hawaii、アメリカ、98616-2396
- University of Hawaii
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Illinois
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Chicago、Illinois、アメリカ、60612
- Rush Presbyterian - Saint Luke's Med Ctr
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Chicago、Illinois、アメリカ、60611-3015
- Northwestern University
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Chicago、Illinois、アメリカ、60612
- Cook County Hosp Core Ctr
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Chicago、Illinois、アメリカ、60614
- Chicago Childrens Memorial Hospital (Pediatric)
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Indiana
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Indianapolis、Indiana、アメリカ、46202
- Indiana Univ Hosp
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Michigan
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Detroit、Michigan、アメリカ、48201
- Childrens Hospital of Michigan
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Detroit、Michigan、アメリカ、48201-1427
- Hutzel Hospital
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Minnesota
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Minneapolis、Minnesota、アメリカ、55455-0392
- Hennepin County Med Clinic
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New Jersey
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Newark、New Jersey、アメリカ、07103
- Univ of Med & Dentistry of NJ/Univ Hosp
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New York
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Bronx、New York、アメリカ、10461
- Jacobi Med Ctr
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New York、New York、アメリカ、10032-3784
- Columbia University
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New York,、New York、アメリカ、10016-6481
- NYU/Bellevue
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Stony Brook、New York、アメリカ、11794-8111
- State Univ of New York at Stony Brook
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North Carolina
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Chapel Hill、North Carolina、アメリカ、27514
- Univ of North Carolina
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Durham、North Carolina、アメリカ、27710
- Duke Univ Med Ctr
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Ohio
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Cleveland、Ohio、アメリカ、44106
- Case Western Reserve Univ
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Cleveland、Ohio、アメリカ、44109-1998
- MetroHealth Med Ctr
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15213-2582
- University of Pittsburgh
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Rhode Island
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Providence、Rhode Island、アメリカ、02906
- Miriam Hosp / Brown Univ
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Tennessee
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Memphis、Tennessee、アメリカ、38105-2794
- The Regional Med Ctr, Memphis
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Nashville、Tennessee、アメリカ、37203
- Comprehensive Care Clinic
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Texas
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Dallas、Texas、アメリカ、75235-9173
- University of Texas, Southwestern Medical Center
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Washington
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Seattle、Washington、アメリカ、98104
- Univ of Washington (Seattle)
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San Juan、プエルトリコ
- San Juan City Hosp
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
協力者と研究者
捜査官
- スタディチェア：Beverly Sha
- スタディチェア：Alice Stek
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ACTG A5150
- ACTG A5153s
- AACTG A5150
- AACTG A5153s
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