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
4 other identifiers
observational
129
2 countries
32
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2002
CompletedFirst Posted
Study publicly available on registry
July 22, 2002
CompletedJuly 24, 2012
July 1, 2012
July 19, 2002
July 23, 2012
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Los Angeles County Medical Center/USC
Los Angeles, California, 90033, United States
UCLA School of Medicine
Los Angeles, California, 90095-1793, United States
UCSD Mother, Child & Adolescent HIV Program
San Diego, California, 92103, United States
San Francisco General Hosp
San Francisco, California, 94110, United States
Univ of Florida- Health Science Ctr
Jacksonville, Florida, 32209, United States
Emory Univ
Atlanta, Georgia, 30308, United States
University of Hawaii
Honolulu, Hawaii, 98616-2396, United States
Northwestern University
Chicago, Illinois, 60611-3015, United States
Cook County Hosp Core Ctr
Chicago, Illinois, 60612, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Chicago Childrens Memorial Hospital (Pediatric)
Chicago, Illinois, 60614, United States
Indiana Univ Hosp
Indianapolis, Indiana, 46202, United States
Hutzel Hospital
Detroit, Michigan, 48201-1427, United States
Childrens Hospital of Michigan
Detroit, Michigan, 48201, United States
Hennepin County Med Clinic
Minneapolis, Minnesota, 55455-0392, United States
Univ of Med & Dentistry of NJ/Univ Hosp
Newark, New Jersey, 07103, United States
NYU/Bellevue
New York, New York, 10016-6481, United States
Columbia University
New York, New York, 10032-3784, United States
State Univ of New York at Stony Brook
Stony Brook, New York, 11794-8111, United States
Jacobi Med Ctr
The Bronx, New York, 10461, United States
Univ of North Carolina
Chapel Hill, North Carolina, 27514, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Case Western Reserve Univ
Cleveland, Ohio, 44106, United States
MetroHealth Med Ctr
Cleveland, Ohio, 44109-1998, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213-2582, United States
Miriam Hosp / Brown Univ
Providence, Rhode Island, 02906, United States
The Regional Med Ctr, Memphis
Memphis, Tennessee, 38105-2794, United States
Comprehensive Care Clinic
Nashville, Tennessee, 37203, United States
University of Texas, Southwestern Medical Center
Dallas, Texas, 75235-9173, United States
Univ of Washington (Seattle)
Seattle, Washington, 98104, United States
San Juan City Hosp
San Juan, Puerto Rico
Related Publications (5)
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.
PMID: 9117455BACKGROUNDRich 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.
PMID: 7594657BACKGROUNDCao 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.
PMID: 9142125BACKGROUNDBurns 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.
PMID: 9500499BACKGROUNDSha 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.
PMID: 21388937RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Beverly Sha
- STUDY CHAIR
Alice Stek