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HIV InfectionsNCT00028145

Prenatal and Postnatal Studies of Interventions for Prevention of Mother-To-Child Transmission

An observational study of HIV Infections and Pregnancy Complications, Infectious, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 77 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 14 years and older, women only
What is being tested?
Adherence assessment
How many people
3,090 participants
Where
77 sitesin 2 countries
Study dates
Oct 2002to Jun 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Primary care clinics

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

77 sites in 2 countries.

77 sites in 2 countries

United States75 sites

  • Med College of Georgia

    Augusta, Georgia, 30912

  • University of Maryland Baltimore NICHD CRS (5094)

    Baltimore, Maryland, 21201

  • Johns Hopkins University NICHD CRS (5092)

    Baltimore, Maryland, 21287

  • Univ. of Alabama Birmingham NICHD CRS (5096)

    Birmingham, Alabama, 35233

  • Children's Hospital of Boston NICHD CRS (5009)

    Boston, Massachusetts, 02115

  • Boston Med Ctr (Pediatric) (5011)

    Boston, Massachusetts, 02118

  • Brigham and Women's Hosp

    Boston, Massachusetts, 02478

  • Children's Hospital at Downstate

    Brooklyn, New York, 11203-2098

  • Womens & Childrens HIV Program

    Chicago, Illinois, 60608-1797

  • Mt Sinai Hosp Med Ctr / Dept of Pediatrics

    Chicago, Illinois, 60608

  • Univ of Illinois

    Chicago, Illinois, 60612-7234

  • Cook County Hospital

    Chicago, Illinois, 60612

  • Rush University Cook County Hospital NICHD CRS (5083)

    Chicago, Illinois, 60612

  • Chicago Childrens Memorial Hosp (Pediatric)

    Chicago, Illinois, 60614

  • Univ of Chicago Children's Hosp (4001)

    Chicago, Illinois, 60637-1470

  • The Medical Center

    Columbus, Georgia, 31901

  • University of Colorado Denver NICHD CRS (5052)

    Denver, Colorado, 80218-1088

  • Hutzel Hospital (5089)

    Detroit, Michigan, 48201-1427

  • Wayne State University Detroit Children's Hosp of Michigan (5041)

    Detroit, Michigan, 48201

  • Duke Univ (Pediatric) (DUMC) (4701)

    Durham, North Carolina, 27705

  • Connecticut Childrens Medical Center (Pediatric)

    Farmington, Connecticut, 06030-3805

  • University of Connecticut, Farmington

    Farmington, Connecticut, 06030-3805

  • South Florida CDC Ft Lauderdale NICHD CRS (5055)

    Fort Lauderdal, Florida, 33316

  • North Broward Hosp District

    Fort Lauderdale, Florida, 33311

  • Texas Children's Hosp / Baylor Univ (3801)

    Houston, Texas, 77030

  • University of Florida Jacksonville (5051)

    Jacksonville, Florida, 32209

  • Long Beach Memorial (Pediatric)

    Long Beach, California, 90801

  • Miller Children's Hospital Long Beach (5093)

    Long Beach, California, 90806

  • Los Angeles County Medical Center/USC

    Los Angeles, California, 90033

  • Usc La Nichd Crs (5048)

    Los Angeles, California, 90033

  • UCLA Med Ctr / Pediatric

    Los Angeles, California, 900951752

  • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601)

    Los Angeles, California, 90095

  • The Regional Med Ctr, Memphis (6502)

    Memphis, Tennessee, 38105-2794

  • St. Jude Childrens Research Hosp, Memphis (6501)

    Memphis, Tennessee, 38105

  • Jackson Memorial Hosp

    Miami, Florida, 33136

  • University of Miami Pediatric/Perinatal HIV/AIDS (4201)

    Miami, Florida, 33136

  • University of South Alabama

    Mobile, Alabama, 36688

  • Vanderbilt Univ Med Ctr

    Nashville, Tennessee, 37232

  • Yale Univ School of Med

    New Haven, Connecticut, 06504

  • Tulane University New Orleans (5095)

    New Orleans, Louisiana, 70112-2699

  • Tulane-Lakeside Hospital

    New Orleans, Louisiana, 70112-2699

  • Tulane University Charity Hosp of New Orleans (7201)

    New Orleans, Louisiana, 70112

  • New York University NY (5012)

    New York, New York, 10016

  • NYU/Bellevue Hospital

    New York, New York, 10016

  • Metropolitan Hosp Ctr (5003)

    New York, New York, 10029

  • Columbia IMPAACT CRS (4101)

    New York, New York, 10032

  • Univ of Medicine & Dentistry of New Jersey / Univ Hosp (P2802)

    Newark, New Jersey, 07103-2714

  • New Jersey Medical School (2802)

    Newark, New Jersey, 07103

  • Univ of Med & Dentistry of New Jersey/Univ Hosp

    Newark, New Jersey, 07103

  • Hahnemann University Hospital (6706)

    Philadelphia, Pennsylvania, 19102-1192

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • The Children's Hospital of Philadelphia (6701)

    Philadelphia, Pennsylvania, 19134

  • Phoenix Childrens Hospital

    Phoenix, Arizona, 85006

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Univ of Rochester Med Ctr

    Rochester, New York, 14642

  • Univ of California, San Diego (4601)

    San Diego, California, 92103

  • Univ. of California San Francisco NICHD CRS (5091)

    San Francisco, California, 94117

  • Univ of Washington Children's Hospital Seattle (5017)

    Seattle, Washington, 98105-0371

  • Harborview Medical Center NICHD CRS (5027)

    Seattle, Washington, 98105

  • University of Washington NICHD CRS (5029)

    Seattle, Washington, 98105

  • Baystate Med Ctr of Springfield

    Springfield, Massachusetts, 01199

  • St. Louis Children's Hosp

    St Louis, Missouri, 63108-2138

  • University of South Florida at Tampa (5018)

    St. Petersburg, Florida, 33701

  • State Univ of New York at Stony Brook (5040)

    Stony Brook, New York, 11776

  • SUNY Upstate Medical Univ

    Syracuse, New York, 13210

  • Lincoln Medical & Mental Health Center

    The Bronx, New York, 10451

  • Bronx-Lebanon Hospital IMPAACT (6901)

    The Bronx, New York, 10457

  • Jacobi Med. Ctr. Bronx NICHD CRS (5013)

    The Bronx, New York, 10461

  • Montefiore Medical / AECOM

    The Bronx, New York, 19461

  • Harbor-UCLA Med Ctr (5045)

    Torrance, California, 90509

  • Children's National Medical Center Washington DC NICHD CRS (5015)

    Washington D.C., District of Columbia, 20010-2970

  • Washington Hospital Center NICHD CRS (5023)

    Washington D.C., District of Columbia, 200102931

  • Howard Univ Hosp (5044)

    Washington D.C., District of Columbia, 20060

  • WNE Maternal Pediatric Adolescent AIDS CRS (7301)

    Worcester, Massachusetts, 01605

  • Univ of Massachusetts Med School

    Worcester, Massachusetts, 01655

Other trials in United States

Puerto Rico2 sites

  • University of Puerto Rico Pediatric HIV/AIDS (6601)

    San Juan, 00936-5067

  • San Juan City Hosp. PR NICHD CRS (5031)

    San Juan, 00936-7344

Other trials in Puerto Rico

About this study

Official title: Perinatal Core Protocol

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.

Read the 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.

Being tested
Adherence assessment
Keywords
Women's Health, Disease Transmission, Vertical, Preventive Medicine, Treatment Experienced
Medical subject headings
HIV Infections, Pregnancy Complications, Infectious

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adherence assessmentBehavioural

    Adherence will be assessed using questionnaires at all study visits.

Study groups in NCT00028145
Study groupRoleWhat they receive
1Pregnant, HIV-infected women
Receives: Behavioral: Adherence assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maternal and infant response to prescribed interventions

    Measured: Throughout study

  2. Immune and viral parameters of participants taking prescribed interventions

    Measured: Throughout study

Secondary outcomes (4)

  1. Occurrences of genotypic and phenotypic resistance in HIV-infected mothers

    Measured: Throughout study

  2. Clinical, immunological, and virological responses in HIV-infected women

    Measured: Throughout study

  3. Mother-to-child transmission rates of resistance mutations

    Measured: Throughout study

  4. Adherence to ART among HIV-infected pregnant women during pregnancy and postpartum

    Measured: Throughout study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2001 (estimated)
  2. Study startOct 2002
  3. Primary completionJun 2013
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,090 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00028145
Sponsor's protocol ID
PACTG P1025
Other IDs
U01AI068632
Status last verified
Oct 2014
First submitted
13 Dec 2001
Last updated
10 Oct 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17456464

  • 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.

    PubMed 18005515

  • 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.

    PubMed 18614923

  • 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.

    PubMed 33982083

  • 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.

    PubMed 28575201

  • 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.

    PubMed 28277349

  • 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.

    PubMed 27082506

  • 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.

    PubMed 25599347

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections and Pregnancy Complications, Infectious, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 77 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maternal and infant response to prescribed interventions (time frame: Throughout study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00028145, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2014.

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