Clinical trial NCT00028145: Prenatal and Postnatal Studies of Interventions for Prevention of Mother-To-Child Transmission
Official title: Perinatal Core Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Pregnancy Complications, Infectious
Keywords: Women's Health
Disease Transmission, Vertical
Preventive Medicine
Treatment Experienced
Lead sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2001-12-14
Enrollment: 3090
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinics

Brief summary: The purpose of this study is to collect and study clinical and laboratory information about a pregnant or new mother and her medical care that will increase our knowledge of the best care for HIV-infected pregnant women and their children.

The rate of transmission of HIV from mothers to their infants has gone down. Specific U.S. Public Health Service guidelines recommend that HIV-infected pregnant women be treated with anti-HIV therapies; but the effectiveness of treatment and safety for the mother and her infant have not been fully examined. This study will monitor the health of women and their infants while they receive anti-HIV therapy. Also, this study will provide information that may be used for future studies.

Detailed description: The current low rate of vertical transmission of HIV in the U.S. limits the number and types of questions concerning transmission risk and pathogenesis that can be addressed by a single clinical trial. Specific U.S. Public Health Service guidelines recommend antiretroviral therapy (ART) during pregnancy to maximize health of women. However, data regarding the effectiveness and safety of and adherence to ART during pregnancy are limited. It is both appropriate and necessary for theInternational Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) to recruit pregnant women into a non-interventional, analytic, epidemiologic study to methodically collect clinical and laboratory data from them and their infants. This way, the IMPAACT can achieve the aims of evaluating management of HIV-infected women during pregnancy and determining the safety and effectiveness of ART and other interventions intended to prevent vertical transmission and/or improve maternal health. In addition, longitudinally collected core protocol data and repository specimens will enable future substudies.

Participants receive no protocol specific treatment or other intervention as part of this study. The study involves the follow-up of HIV-infected women enrolled during pregnancy or at the time of delivery for 6 months postpartum and their infants for the first 6 months of life. There will be 8 study visits for enrolled participants and 6 study visits for infants. Data concerning ART use, adherence to medications, and review of symptoms relevant to side effects and toxicities are collected through administration of questionnaires at all maternal visits. Phlebotomy is conducted to obtain specimens for a repository and for required laboratory tests. During labor and delivery, maternal blood is obtained for lymphocyte subset and viral load assays and for repository storage. Collection of amniotic fluid at the time of cesarean section is encouraged. These collections are submitted to a central repository. Data for the core protocol are abstracted from the infant's medical record at the time of birth and at each postnatal visit.

Eligibility criteria: Inclusion Criteria:

* HIV infected
* At least 14 weeks pregnant OR have delivered a liveborn or stillborn infant and are within 14 days of the delivery
* Currently receiving care at an IMPAACT or other participating site
* Have a parent or guardian willing to provide signed informed consent, if applicable
* Mentally capable of giving informed consent to have the infant and self followed at an IMPAACT site

Exclusion Criteria:

* Intend to end the pregnancy
* Unable to come for a study visit within 14 days after delivery (if known to be HIV infected prior to delivery) OR within 28 days after delivery (if found to be HIV infected at the time of labor and delivery or within 14 days after delivery)

Primary outcomes:
measure: Maternal and infant response to prescribed interventions
timeFrame: Throughout study
measure: Immune and viral parameters of participants taking prescribed interventions
timeFrame: Throughout study
Secondary outcomes:
measure: Occurrences of genotypic and phenotypic resistance in HIV-infected mothers
timeFrame: Throughout study
measure: Clinical, immunological, and virological responses in HIV-infected women
timeFrame: Throughout study
measure: Mother-to-child transmission rates of resistance mutations
timeFrame: Throughout study
measure: Adherence to ART among HIV-infected pregnant women during pregnancy and postpartum
timeFrame: Throughout study
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ. of Alabama Birmingham NICHD CRS (5096)
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Childrens Hospital
state: Arizona
city: Long Beach
country: United States
facility: Long Beach Memorial (Pediatric)
state: California
city: Long Beach
country: United States
facility: Miller Children's Hospital Long Beach (5093)
state: California
city: Los Angeles
country: United States
facility: Los Angeles County Medical Center/USC
state: California
city: Los Angeles
country: United States
facility: Usc La Nichd Crs (5048)
state: California
city: Los Angeles
country: United States
facility: UCLA Med Ctr / Pediatric
state: California
city: Los Angeles
country: United States
facility: UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601)
state: California
city: San Diego
country: United States
facility: Univ of California, San Diego (4601)
state: California
city: San Francisco
country: United States
facility: Univ. of California San Francisco NICHD CRS (5091)
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Med Ctr (5045)
state: California
city: Denver
country: United States
facility: University of Colorado Denver NICHD CRS (5052)
state: Colorado
city: Farmington
country: United States
facility: Connecticut Childrens Medical Center (Pediatric)
state: Connecticut
city: Farmington
country: United States
facility: University of Connecticut, Farmington
state: Connecticut
city: New Haven
country: United States
facility: Yale Univ School of Med
state: Connecticut
city: Washington
country: United States
facility: Children's National Medical Center Washington DC NICHD CRS (5015)
state: District of Columbia
city: Washington
country: United States
facility: Washington Hospital Center NICHD CRS (5023)
state: District of Columbia
city: Washington
country: United States
facility: Howard Univ Hosp (5044)
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: North Broward Hosp District
state: Florida
city: Ft Lauderdal
country: United States
facility: South Florida CDC Ft Lauderdale NICHD CRS (5055)
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Jacksonville (5051)
state: Florida
city: Miami
country: United States
facility: Jackson Memorial Hosp
state: Florida
city: Miami
country: United States
facility: University of Miami Pediatric/Perinatal HIV/AIDS (4201)
state: Florida
city: St Petersburg
country: United States
facility: University of South Florida at Tampa (5018)
state: Florida
city: Augusta
country: United States
facility: Med College of Georgia
state: Georgia
city: Columbus
country: United States
facility: The Medical Center
state: Georgia
city: Chicago
country: United States
facility: Womens & Childrens HIV Program
state: Illinois
city: Chicago
country: United States
facility: Mt Sinai Hosp Med Ctr / Dept of Pediatrics
state: Illinois
city: Chicago
country: United States
facility: Univ of Illinois
state: Illinois
city: Chicago
country: United States
facility: Cook County Hospital
state: Illinois
city: Chicago
country: United States
facility: Rush University Cook County Hospital NICHD CRS (5083)
state: Illinois
city: Chicago
country: United States
facility: Chicago Childrens Memorial Hosp (Pediatric)
state: Illinois
city: Chicago
country: United States
facility: Univ of Chicago Children's Hosp (4001)
state: Illinois
city: New Orleans
country: United States
facility: Tulane University New Orleans (5095)
state: Louisiana
city: New Orleans
country: United States
facility: Tulane-Lakeside Hospital
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University Charity Hosp of New Orleans (7201)
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Baltimore NICHD CRS (5094)
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University NICHD CRS (5092)
state: Maryland
city: Boston
country: United States
facility: Children's Hospital of Boston NICHD CRS (5009)
state: Massachusetts
city: Boston
country: United States
facility: Boston Med Ctr (Pediatric) (5011)
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hosp
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Med Ctr of Springfield
state: Massachusetts
city: Worcester
country: United States
facility: WNE Maternal Pediatric Adolescent AIDS CRS (7301)
state: Massachusetts
city: Worcester
country: United States
facility: Univ of Massachusetts Med School
state: Massachusetts
city: Detroit
country: United States
facility: Hutzel Hospital (5089)
state: Michigan
city: Detroit
country: United States
facility: Wayne State University Detroit Children's Hosp of Michigan (5041)
state: Michigan
city: St. Louis
country: United States
facility: St. Louis Children's Hosp
state: Missouri
city: Newark
country: United States
facility: Univ of Medicine & Dentistry of New Jersey / Univ Hosp (P2802)
state: New Jersey
city: Newark
country: United States
facility: New Jersey Medical School (2802)
state: New Jersey
city: Newark
country: United States
facility: Univ of Med & Dentistry of New Jersey/Univ Hosp
state: New Jersey
city: Bronx
country: United States
facility: Lincoln Medical & Mental Health Center
state: New York
city: Bronx
country: United States
facility: Bronx-Lebanon Hospital IMPAACT (6901)
state: New York
city: Bronx
country: United States
facility: Jacobi Med. Ctr. Bronx NICHD CRS (5013)
state: New York
city: Bronx
country: United States
facility: Montefiore Medical / AECOM
state: New York
city: Brooklyn
country: United States
facility: Children's Hospital at Downstate
state: New York
city: New York
country: United States
facility: New York University NY (5012)
state: New York
city: New York
country: United States
facility: NYU/Bellevue Hospital
state: New York
city: New York
country: United States
facility: Metropolitan Hosp Ctr (5003)
state: New York
city: New York
country: United States
facility: Columbia IMPAACT CRS (4101)
state: New York
city: Rochester
country: United States
facility: Univ of Rochester Med Ctr
state: New York
city: Stony Brook
country: United States
facility: State Univ of New York at Stony Brook (5040)
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical Univ
state: New York
city: Durham
country: United States
facility: Duke Univ (Pediatric) (DUMC) (4701)
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Hahnemann University Hospital (6706)
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia (6701)
state: Pennsylvania
city: Memphis
country: United States
facility: The Regional Med Ctr, Memphis (6502)
state: Tennessee
city: Memphis
country: United States
facility: St. Jude Childrens Research Hosp, Memphis (6501)
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Univ Med Ctr
state: Tennessee
city: Houston
country: United States
facility: Texas Children's Hosp / Baylor Univ (3801)
state: Texas
city: Seattle
country: United States
facility: Univ of Washington Children's Hospital Seattle (5017)
state: Washington
city: Seattle
country: United States
facility: Harborview Medical Center NICHD CRS (5027)
state: Washington
city: Seattle
country: United States
facility: University of Washington NICHD CRS (5029)
state: Washington
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico Pediatric HIV/AIDS (6601)
city: San Juan
country: Puerto Rico
facility: San Juan City Hosp. PR NICHD CRS (5031)
Study officials:
affiliation: Director of Obstetrics and Gynecology, Brigham and Women's Hospital
name: Ruth Tuomala, MD
role: STUDY_CHAIR
affiliation: Pediatric Infectious Diseases, University of Miami School of Medicine
name: Gwen Scott, MD
role: STUDY_CHAIR
References:
citation: Ciambrone D, Loewenthal HG, Bazerman LB, Zorilla C, Urbina B, Mitty JA. Adherence among women with HIV infection in Puerto Rico: the potential use of modified directly observed therapy (MDOT) among pregnant and postpartum women. Women Health. 2006;44(4):61-77. doi: 10.1300/j013v44n04_04.
citation: Kingston MA, Letham CJ, McQuillan O. Adherence to antiretroviral therapy in pregnancy. Int J STD AIDS. 2007 Nov;18(11):787-9. doi: 10.1258/095646207782212216.
citation: Bardeguez AD, Lindsey JC, Shannon M, Tuomala RE, Cohn SE, Smith E, Stek A, Buschur S, Cotter A, Bettica L, Read JS; PACTG 1025 Protocol Team. Adherence to antiretrovirals among US women during and after pregnancy. J Acquir Immune Defic Syndr. 2008 Aug 1;48(4):408-17. doi: 10.1097/QAI.0b013e31817bbe80.
citation: Momplaisir F, Hussein M, Kacanek D, Brady K, Agwu A, Scott G, Tuomala R, Bennett D. Perinatal Depressive Symptoms, Human Immunodeficiency Virus (HIV) Suppression, and the Underlying Role of Antiretroviral Therapy Adherence: A Longitudinal Mediation Analysis in the IMPAACT P1025 Cohort. Clin Infect Dis. 2021 Oct 20;73(8):1379-1387. doi: 10.1093/cid/ciab416.
citation: Jao J, Kacanek D, Williams PL, Geffner ME, Livingston EG, Sperling RS, Patel K, Bardeguez AD, Burchett SK, Chakhtoura N, Scott GB, Van Dyke RB, Abrams EJ; Pediatric HIV/AIDS Cohort Study and the International Maternal Pediatric Adolescent AIDS Clinical Trials P1025 Protocol; Pediatric HIV/AIDS Cohort Study and the International Maternal Pediatric Adolescent AIDS Clinical Trials P1025 Protocol. Birth Weight and Preterm Delivery Outcomes of Perinatally vs Nonperinatally Human Immunodeficiency Virus-Infected Pregnant Women in the United States: Results From the PHACS SMARTT Study and IMPAACT P1025 Protocol. Clin Infect Dis. 2017 Sep 15;65(6):982-989. doi: 10.1093/cid/cix488.
citation: Scott GB, Brogly SB, Muenz D, Stek AM, Read JS; International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) P1025 Study Team. Missed Opportunities for Prevention of Mother-to-Child Transmission of Human Immunodeficiency Virus. Obstet Gynecol. 2017 Apr;129(4):621-628. doi: 10.1097/AOG.0000000000001929.
citation: Livingston EG, Huo Y, Patel K, Tuomala RE, Scott GB, Stek A; P1025 Team of the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Group. Complications and Route of Delivery in a Large Cohort Study of HIV-1-Infected Women-IMPAACT P1025. J Acquir Immune Defic Syndr. 2016 Sep 1;73(1):74-82. doi: 10.1097/QAI.0000000000001021.
citation: Katz IT, Leister E, Kacanek D, Hughes MD, Bardeguez A, Livingston E, Stek A, Shapiro DE, Tuomala R. Factors associated with lack of viral suppression at delivery among highly active antiretroviral therapy-naive women with HIV: a cohort study. Ann Intern Med. 2015 Jan 20;162(2):90-9. doi: 10.7326/M13-2005.