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

HIV Infections Clinical Trial

Official title:

Perinatal Core Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00028145
• Other study ID #: PACTG P1025
• Secondary ID: U01AI068632
• Status: Completed
• Phase: N/A
• First received: December 13, 2001
• Last updated: October 8, 2014
• Start date: October 2002
• Est. completion date: June 2013

Study information

• Verified date: October 2014
• Source: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3090
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infections
• Pregnancy Complications
• Pregnancy Complications, Infectious

Intervention

Behavioral:
• Adherence assessment
Adherence will be assessed using questionnaires at all study visits.

Locations

Country	Name	City	State
Puerto Rico	San Juan City Hosp. PR NICHD CRS (5031)	San Juan
Puerto Rico	University of Puerto Rico Pediatric HIV/AIDS (6601)	San Juan
United States	Med College of Georgia	Augusta	Georgia
United States	Johns Hopkins University NICHD CRS (5092)	Baltimore	Maryland
United States	University of Maryland Baltimore NICHD CRS (5094)	Baltimore	Maryland
United States	Univ. of Alabama Birmingham NICHD CRS (5096)	Birmingham	Alabama
United States	Boston Med Ctr (Pediatric) (5011)	Boston	Massachusetts
United States	Brigham and Women's Hosp	Boston	Massachusetts
United States	Children's Hospital of Boston NICHD CRS (5009)	Boston	Massachusetts
United States	Bronx-Lebanon Hospital IMPAACT (6901)	Bronx	New York
United States	Jacobi Med. Ctr. Bronx NICHD CRS (5013)	Bronx	New York
United States	Lincoln Medical & Mental Health Center	Bronx	New York
United States	Montefiore Medical / AECOM	Bronx	New York
United States	Children's Hospital at Downstate	Brooklyn	New York
United States	Chicago Childrens Memorial Hosp (Pediatric)	Chicago	Illinois
United States	Cook County Hospital	Chicago	Illinois
United States	Mt Sinai Hosp Med Ctr / Dept of Pediatrics	Chicago	Illinois
United States	Rush University Cook County Hospital NICHD CRS (5083)	Chicago	Illinois
United States	Univ of Chicago Children's Hosp (4001)	Chicago	Illinois
United States	Univ of Illinois	Chicago	Illinois
United States	Womens & Childrens HIV Program	Chicago	Illinois
United States	The Medical Center	Columbus	Georgia
United States	University of Colorado Denver NICHD CRS (5052)	Denver	Colorado
United States	Hutzel Hospital (5089)	Detroit	Michigan
United States	Wayne State University Detroit Children's Hosp of Michigan (5041)	Detroit	Michigan
United States	Duke Univ (Pediatric) (DUMC) (4701)	Durham	North Carolina
United States	Connecticut Childrens Medical Center (Pediatric)	Farmington	Connecticut
United States	University of Connecticut, Farmington	Farmington	Connecticut
United States	North Broward Hosp District	Fort Lauderdale	Florida
United States	South Florida CDC Ft Lauderdale NICHD CRS (5055)	Ft Lauderdal	Florida
United States	Texas Children's Hosp / Baylor Univ (3801)	Houston	Texas
United States	University of Florida Jacksonville (5051)	Jacksonville	Florida
United States	Long Beach Memorial (Pediatric)	Long Beach	California
United States	Miller Children's Hospital Long Beach (5093)	Long Beach	California
United States	Los Angeles County Medical Center/USC	Los Angeles	California
United States	UCLA Med Ctr / Pediatric	Los Angeles	California
United States	UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601)	Los Angeles	California
United States	Usc La Nichd Crs (5048)	Los Angeles	California
United States	St. Jude Childrens Research Hosp, Memphis (6501)	Memphis	Tennessee
United States	The Regional Med Ctr, Memphis (6502)	Memphis	Tennessee
United States	Jackson Memorial Hosp	Miami	Florida
United States	University of Miami Pediatric/Perinatal HIV/AIDS (4201)	Miami	Florida
United States	University of South Alabama	Mobile	Alabama
United States	Vanderbilt Univ Med Ctr	Nashville	Tennessee
United States	Yale Univ School of Med	New Haven	Connecticut
United States	Tulane University Charity Hosp of New Orleans (7201)	New Orleans	Louisiana
United States	Tulane University New Orleans (5095)	New Orleans	Louisiana
United States	Tulane-Lakeside Hospital	New Orleans	Louisiana
United States	Columbia IMPAACT CRS (4101)	New York	New York
United States	Metropolitan Hosp Ctr (5003)	New York	New York
United States	New York University NY (5012)	New York	New York
United States	NYU/Bellevue Hospital	New York	New York
United States	New Jersey Medical School (2802)	Newark	New Jersey
United States	Univ of Med & Dentistry of New Jersey/Univ Hosp	Newark	New Jersey
United States	Univ of Medicine & Dentistry of New Jersey / Univ Hosp (P2802)	Newark	New Jersey
United States	Hahnemann University Hospital (6706)	Philadelphia	Pennsylvania
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	The Children's Hospital of Philadelphia (6701)	Philadelphia	Pennsylvania
United States	Phoenix Childrens Hospital	Phoenix	Arizona
United States	Oregon Health and Science University	Portland	Oregon
United States	Univ of Rochester Med Ctr	Rochester	New York
United States	Univ of California, San Diego (4601)	San Diego	California
United States	Univ. of California San Francisco NICHD CRS (5091)	San Francisco	California
United States	Harborview Medical Center NICHD CRS (5027)	Seattle	Washington
United States	Univ of Washington Children's Hospital Seattle (5017)	Seattle	Washington
United States	University of Washington NICHD CRS (5029)	Seattle	Washington
United States	Baystate Med Ctr of Springfield	Springfield	Massachusetts
United States	University of South Florida at Tampa (5018)	St Petersburg	Florida
United States	St. Louis Children's Hosp	St. Louis	Missouri
United States	State Univ of New York at Stony Brook (5040)	Stony Brook	New York
United States	SUNY Upstate Medical Univ	Syracuse	New York
United States	Harbor-UCLA Med Ctr (5045)	Torrance	California
United States	Children's National Medical Center Washington DC NICHD CRS (5015)	Washington	District of Columbia
United States	Howard Univ Hosp (5044)	Washington	District of Columbia
United States	Washington Hospital Center NICHD CRS (5023)	Washington	District of Columbia
United States	Univ of Massachusetts Med School	Worcester	Massachusetts
United States	WNE Maternal Pediatric Adolescent AIDS CRS (7301)	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
International Maternal Pediatric Adolescent AIDS Clinical Trials Group	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (3)

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;4 — View 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. — View Citation

Kingston MA, Letham CJ, McQuillan O. Adherence to antiretroviral therapy in pregnancy. Int J STD AIDS. 2007 Nov;18(11):787-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal and infant response to prescribed interventions		Throughout study	Yes
Primary	Immune and viral parameters of participants taking prescribed interventions		Throughout study	Yes
Secondary	Occurrences of genotypic and phenotypic resistance in HIV-infected mothers		Throughout study	Yes
Secondary	Clinical, immunological, and virological responses in HIV-infected women		Throughout study	Yes
Secondary	Mother-to-child transmission rates of resistance mutations		Throughout study	Yes
Secondary	Adherence to ART among HIV-infected pregnant women during pregnancy and postpartum		Throughout study	Yes

External Links

•   Click here for the AIDSinfo Perinatal Guidelines
•   Haga clic aquí para ver información sobre este ensayo clínico en español