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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering
Kontakter og plasseringer
Studiesteder
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Alabama
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Birmingham, Alabama, Forente stater, 35294
- Univ of Alabama at Birmingham
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California
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Los Angeles, California, Forente stater, 90095-1793
- UCLA School of Medicine
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Los Angeles, California, Forente stater, 90033
- Los Angeles County Medical Center/USC
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San Diego, California, Forente stater, 92103
- UCSD Mother, Child & Adolescent HIV Program
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San Francisco, California, Forente stater, 94110
- San Francisco General Hosp
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Florida
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Jacksonville, Florida, Forente stater, 32209
- Univ of Florida- Health Science Ctr
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Georgia
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Atlanta, Georgia, Forente stater, 30308
- Emory Univ
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Hawaii
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Honolulu, Hawaii, Forente stater, 98616-2396
- University of Hawaii
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Illinois
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Chicago, Illinois, Forente stater, 60612
- Rush Presbyterian - Saint Luke's Med Ctr
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Chicago, Illinois, Forente stater, 60611-3015
- Northwestern University
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Chicago, Illinois, Forente stater, 60612
- Cook County Hosp Core Ctr
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Chicago, Illinois, Forente stater, 60614
- Chicago Childrens Memorial Hospital (Pediatric)
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Indiana
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Indianapolis, Indiana, Forente stater, 46202
- Indiana Univ Hosp
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Michigan
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Detroit, Michigan, Forente stater, 48201
- Childrens Hospital of Michigan
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Detroit, Michigan, Forente stater, 48201-1427
- Hutzel Hospital
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55455-0392
- Hennepin County Med Clinic
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New Jersey
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Newark, New Jersey, Forente stater, 07103
- Univ of Med & Dentistry of NJ/Univ Hosp
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New York
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Bronx, New York, Forente stater, 10461
- Jacobi Med Ctr
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New York, New York, Forente stater, 10032-3784
- Columbia University
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New York,, New York, Forente stater, 10016-6481
- NYU/Bellevue
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Stony Brook, New York, Forente stater, 11794-8111
- State Univ of New York at Stony Brook
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North Carolina
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Chapel Hill, North Carolina, Forente stater, 27514
- Univ of North Carolina
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Durham, North Carolina, Forente stater, 27710
- Duke Univ Med Ctr
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Ohio
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Cleveland, Ohio, Forente stater, 44106
- Case Western Reserve Univ
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Cleveland, Ohio, Forente stater, 44109-1998
- MetroHealth Med Ctr
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15213-2582
- University of Pittsburgh
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Rhode Island
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Providence, Rhode Island, Forente stater, 02906
- Miriam Hosp / Brown Univ
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Tennessee
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Memphis, Tennessee, Forente stater, 38105-2794
- The Regional Med Ctr, Memphis
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Nashville, Tennessee, Forente stater, 37203
- Comprehensive Care Clinic
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Texas
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Dallas, Texas, Forente stater, 75235-9173
- University of Texas, Southwestern Medical Center
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Washington
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Seattle, Washington, Forente stater, 98104
- Univ of Washington (Seattle)
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San Juan, Puerto Rico
- San Juan City Hosp
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Beverly Sha
- Studiestol: Alice Stek
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ACTG A5150
- ACTG A5153s
- AACTG A5150
- AACTG A5153s
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