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Ensayos clínicos

Ensayos clínicos

Examining Benefits of HAART Continuation in Postpartum Mothers

Patrocinador(es) del estudio: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Números de identificación: NCT00955968, IMPAACT 1077HS
  • Inscripciones abiertas

Propósito del estudio

The purpose of this study is to see if pregnant women receiving highly active antiretroviral treatment (HAART) to prevent mother-to-child transmission of HIV will be healthier if, after delivery, they continue or stop HAART.

Afección:Fase:
Infecciones por el VIH
Fase 4

Detalles del estudio

Highly active antiretroviral therapy (HAART) is not recommended immediately for all

HIV-infected people, only those who have significant illnesses or a CD4 count below 350.

However, in pregnancy, HIV-infected women are recommended to start HAART regardless of their

own HIV progression for prevention of mother-to-child transmission (pMTCT) of HIV. Women who

begin taking HAART for pMTCT often stop treatment after delivery, but new data in

non-pregnant adults indicates that stopping treatment may lead to negative long-term health

outcomes. This study will examine whether it is healthier for pregnant, HIV-infected women

receiving HAART for pMTCT to continue or stop treatment.



Participation in this study will be of variable length; participants will be recruited over

four years, and all participants will continue to be followed until 84 weeks after the last

woman is assigned to a study group. Participants will be randomly assigned to one of two

groups: one group will stop HAART and the other will continue HAART. Participants assigned

to stop HAART will receive instructions from the study staff on how and when to stop taking

medications. These participants will be monitored and will start treatment again if their

HIV progresses.



The first study visit will take place within 28 days of delivery, and subsequent visits will

occur after 4 weeks, 12 weeks, and then every 3 months until the end of the study. During

these study visits, participants will complete questionnaires and interviews about

medication history, receive a physical exam, and have blood and urine collected for HIV

blood tests and pregnancy tests. Participants will also be asked if they are willing to have

some of their blood stored to be used in later testing.Highly active antiretroviral therapy (HAART) is not recommended immediately for all

HIV-infected people, only those who have significant illnesses or a CD4 count below 350.

However, in pregnancy, HIV-infected women are recommended to start HAART regardless of their

own HIV progression for prevention of mother-to-child transmission (pMTCT) of HIV. Women who

begin taking HAART for pMTCT often stop treatment after delivery, but new data in

non-pregnant adults indicates that stopping treatment may lead to negative long-term health

outcomes. This study will examine whether it is healthier for pregnant, HIV-infected women

receiving HAART for pMTCT to continue or stop treatment.



Participation in this study will be of variable length; participants will be recruited over

four years, and all participants will continue to be followed until 84 weeks after the last

woman is assigned to a study group. Participants will be randomly assigned to one of two

groups: one group will stop HAART and the other will continue HAART. Participants assigned

to stop HAART will receive instructions from the study staff on how and when to stop taking

medications. These participants will be monitored and will start treatment again if their

HIV progresses.



The first study visit will take place within 28 days of delivery, and subsequent visits will

occur after 4 weeks, 12 weeks, and then every 3 months until the end of the study. During

these study visits, participants will complete questionnaires and interviews about

medication history, receive a physical exam, and have blood and urine collected for HIV

blood tests and pregnancy tests. Participants will also be asked if they are willing to have

some of their blood stored to be used in later testing.

Criterios de inclusión

    :
    • At least 18 years old or having attained the minimum age of independent consent, as
    defined by the local IRB, whichever is greater
    • Confirmed HIV infection, documented by the results of tests performed on two separate
    specimens at any time prior to study entry
    • Documentation of hepatitis C (HCV) antibody, hepatitis B surface antibody (HBsAb),
    and hepatitis B surface antigen (HBsAg) status (if HBsAb status is negative) within 12 months prior to study entry
    • Between delivery and 28 days postpartum
    • Antiretroviral (ARV) treatment naïve, defined as having received less than 14 days of
    one or more antiretroviral agents prior to therapy initiated during current pregnancy NOTE: History of receipt of ARV for perinatal mother-to-child transmission (PMTCT) during prior pregnancies and immediately postpartum is permitted.
    • Receipt of at least 4 weeks of HAART without interruption prior to study entry, at
    least 2 weeks of which must have been received prior to delivery. HAART is defined as three or more agents from two or more classes of antiretroviral therapy (ART). Treatment interruption is defined as more than seven consecutive days of missed therapy. NOTE: Women on a triple nucleoside regimen during pregnancy are eligible but will be switched to a study-provided HAART regimen if randomized to continue HAART (Arm A).
    • CD4 cell count of 400 cells/mm3 or greater on a specimen obtained within 60 days
    prior to initiation of HAART for current pregnancy NOTE: This result will be obtained from the participant's medical records, if available.
    • CD4 cell count of 400 cells/mm3 or greater on HAART and on a specimen obtained within
    45 days prior to study entry
    • Certain laboratory values on a specimen obtained within 45 days prior to study entry.
    More information on this criterion can be found in the protocol.
    • Estimated creatinine clearance greater than or equal to 60mL/min within 45 days prior
    to entry
    • Intent to remain in current geographical area of residence for the duration of the
    study
    • Willingness to attend visits required by the study

Criterios de exclusión

    :
    • Previous participation in PROMISE study (P1077)
    • Receipt of tuberculosis (TB) treatment within 30 days of study entry
    • Clinical indication for HAART, defined as WHO Clinical Stage 3 or 4
    • Serious illness requiring systemic treatment and/or hospitalization until participant
    either completes therapy or is clinically stable on therapy, in the opinion of the investigator, for at least 30 days prior to study entry
    • Social or other circumstances which, in the opinion of the site investigator, would
    hinder long-term follow up
    • Use of any prohibited medications within 14 days prior to study entry (refer to the
    study manual of procedures [MOP] for a list of prohibited medications)
    • Current compulsory detention (involuntary incarceration) in a correctional facility,
    prison, or jail for legal reasons or compulsory detention in a medical facility for treatment of either a psychiatric or physical (e.g., infectious disease) illness
    • Currently breast feeding or planning to breast feed
    • History of documented structural or conduction heart defect (specialized assessments
    to rule out this condition are not required, and a heart murmur alone is not considered exclusionary)
    • Known evidence of Hepatitis B virus (HBV) DNA levels greater than 2000 IU/mL
    (approximately 10,000 copies/mL) in the presence of elevated ALT (testing for this is not required for study screening or enrollment)

Centros de estudio/contactos

Alabama

    Univ. of Alabama Birmingham NICHD CRS (5096), Birmingham, Alabama, 35294, United States

             Sharan Robbins, B.A., 205-996-6418, srobbins@peds.uab.edu

Inscripciones abiertas

California

    Miller Children's Hospital Long Beach (5093), Long Beach, California, 90806, United States

             Susan Marks, RN, 562-933-8093, smarks@memorialcare.org

Inscripciones abiertas

    Usc La Nichd Crs (5048), Los Angeles, California, 90033, United States

             Eva A. Operskalski, PhD, 323-226-5068, eva@usc.edu

Inscripciones abiertas

    UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601), Los Angeles, California, 90095, United States

             Jin Kim, BS, 323-226-5068, jinkim@mednet.ucla.edu

Inscripciones abiertas

    UCSD Mother, Child & Adolescent HIV Program(4601), San Diego, California, 92103, United States

             Linda Proctor, RN, CNM, MSN, 619-543-8080, lproctor@ucsd.edu

Inscripciones abiertas

    Univ. of California San Francisco NICHD CRS (5091), San Francisco, California, 94117, United States

             Ana Moreno, 415-476-9373, morenoal@peds.ucsf.edu

Inscripciones abiertas

    Harbor (UCLA) Medical Center NICHD CRS (5045), Torrance, California, 90509, United States

             Judy Hayes, BSN, RN, 310-781-3627, jhayes@labiomed.org

Inscripciones abiertas

    Harbor Univeristy of California, Los Angeles (UCLA) Medical Center (603), Torrance, California, 90509, United States

             Judy Hayes, BSN, RN, 310-781-3627, jhayes@labiomed.org

Inscripciones pendientes

Colorado

    Childrens Hospital (U. Colorado, Denver) NICHD CRS (5052), Denver, Colorado, 80218-1088, United States

             Emily A. Barr, C.P.N.P, 720-777-6752, barr.emily@tchden.org

Inscripciones abiertas

District of Columbia

    Howard University Washington DC NICHD CRS (5044), Washington, District of Columbia, 20060, United States

             Patricia Houston, 720-777-6752, phouston@howard.edu

Inscripciones abiertas

    Washington Hospital Center NICHD CRS (5023), Washington, District of Columbia, 200102931, United States

             Marla Shauer, 202-877-5811, marla.shauer@medstar.net

Inscripciones abiertas

Florida

    South Florida CDC Ft. Lauderdale NICHD (5055), Ft. Lauderdale, Florida, 33316, United States

             Zulma Eysallenne, RN, 954-728-1125, zeysallenne@browardhealth.org

Inscripciones abiertas

    Univ. of Florida Jacksonville NICHD CRS (5051), Jacksonville, Florida, 32209, United States

             Kathleen Thoma, M.P.H., 904-244-5331, kathleen.thoma@jax.ufl.edu

Inscripciones abiertas

    Univ of Miami Pediatric/Perinatal HIV/AIDS (4201), Miami, Florida, 33136, United States

             Patricia Bryan, 305-243-4447, pbryan@med.miami.edu

Inscripciones abiertas

    Tampa General Hospital NICHD CRS (5111), Tampa, Florida, 33606-3475, United States

             Alicia Marion, A.R.N.P., 305-243-4447, amarion@hsc.usf.edu

Inscripciones abiertas

    University of South Florida Tampa (5018), Tampa, Florida, 33620, United States

             Tammy Meyers, B.S., 813-259-8786, Tmyers@health.usf.edu

Inscripciones abiertas

Illinois

    Chicago Children's CRS(4001), Chicago, Illinois, 60614, United States

             Eric Cagwin, R.N., 773-880-3669, ecagwin@childrensmemorial.org

Inscripciones abiertas

    Rush University Medical Center ACTG CRS (2702), Chicago, Illinois, 60612, United States

             Janice Fritsche, MS, 312-942-4810, jfrits@rush.edu

Inscripciones abiertas

    Rush University Cook County Hospital NICHD CRS (5083), Chicago, Illinois, 60612, United States

             Maureen Haak, RN, MSN, 312-572-4541, maureen_haak@rush.edu

Inscripciones abiertas

Louisiana

    Tulane University (5095), New Orleans, Louisiana, 70112, United States

             Patricia Reilly, RN, CCRC, 504-988-3804, preilly@tulane.edu

Inscripciones abiertas

Maryland

    Johns Hopkins University NICHD CRS (5092), Baltimore, Maryland, 21287, United States

             Todd Noletto, MPH, 443-287-9040, tnolett1@jhmi.edu

Inscripciones abiertas

    Univ of Maryland Baltimore NICHD CRS (5094), Baltimore, Maryland, 21201, United States

             Mary MacFadden, 410-706-8933, mmacfadd@peds.umaryland.edu

Inscripciones abiertas

Massachusetts

    Boston Medical Center Ped. HIV Program NICHD CRS (5011), Boston, Massachusetts, 02118, United States

             Debra McLaud, RN, 617-414-3632, demclaud@bmc.org

Inscripciones abiertas

    Children's Hospital of Boston (5009), Boston, Massachusetts, 02115, United States

             Catherine Kneut, RN, MS, CRNP, 617-355-7879, catherine.kneut@childrens.harvard.edu

Inscripciones abiertas

    WNE Maternal Pediatric Adolescent AIDS CRS (7301), Worcester, Massachusetts, 01605, United States

             Margaret McManus, 508-856-5589, margaret.mcmanus@umassmed.edu

Inscripciones abiertas

Michigan

    Hutzel Hospital NICHD CRS (5089), Detroit, Michigan, 48201, United States

             Tamika Watson, R.N., C.N.M., MAOM, 1-313-993-3429, twatson@med.wayne.edu

Inscripciones abiertas

    Children's Hospital of Michigan NICHD CRS 5041, Detroit, Michigan, 48201, United States

             Ulyssa Hancock, R.N., B.S.N., 313-745-9204, uhancock@dmc.org

Inscripciones abiertas

    Wayne State University/Children's Hospital of Michigan NICHD CRS (5041), Detroit, Michigan, 48201, United States

             Ulyssa Hancock, R.N., B.S.N., 313-745-9204, uhancock@dmc.org

Inscripciones abiertas

New Jersey

    NJ Med School CRS (2802), Newark, New Jersey, 07103, United States

             Linda Bettica, B.S.N., (973) 972-3119, betticlm@umdnj.edu

Inscripciones abiertas

New York

    Jacobi Med. Ctr. Bronx NICHD CRS (5013), Bronx, New York, 10461, United States

             Marlene Burey, 718-918-4783, marlene.burey@nbhn.net

Inscripciones abiertas

    Bronx Lebanon Hospital Center (31469), Bronx, New York, 10457, United States

             Caroline Nubel, 718-960-1020, cnubel@bronxleb.org

Inscripciones pendientes

    Bronx-Lebanon Hospital IMPAACT CRS (6901), Bronx, New York, 10457, United States

             Mary-Elizabeth Vachon, MPH, 718-960-1016, mvachon@bronxleb.org

Inscripciones abiertas

    Columbia IMPAACT CRS (4101), New York, New York, 10032, United States

             Alice Higgins, R.N., M.P.A., 212-305-8181, higgina@nyp.org

Inscripciones abiertas

    Metropolitan Hospital (5003), New York, New York, 10029, United States

             Santa Paul, MD, 212-423-8630, santa.paul@nychhc.org

Inscripciones abiertas

    New York University NY (5012), New York, New York, 10016, United States

             Joseph Bertran, 212-263-8198, Joseph.bertran@nyumc.org

Inscripciones abiertas

    SUNY Stony Brook (5040), Stony Brook, New York, 11794-8111, United States

             Denise M Ferraro, M.S., FNP-BC, 631-444-8225, denise.ferraro@stonybrook.edu

Inscripciones abiertas

North Carolina

    Unc Aids Crs (3201), Chapel Hill, North Carolina, 27514, United States

             Cheryl J. Marcus, BSN, RN, 919-843-8761, cjm@med.unc.edu

Inscripciones abiertas

    Duke University Medical Center (DUMC) Pediatric CRS (4701), Durham, North Carolina, 27710, United States

             John Swetnam, 919-668-4847, swetnam@duke.edu

Inscripciones abiertas

    Wake County Health and Human Services CRS (30076), Raleigh, North Carolina, 27630, United States

             Susan Pedersen, 919-966-6713, spederse@med.unc.edu

Inscripciones abiertas

Ohio

    Ohio State University AIDS CRS (2301), Columbus, Ohio, 43210, United States

             Todd L. Lusch, 614-293-5282, todd.lusch@osumc.edu

Inscripciones abiertas

Pennsylvania

    Childrens Hospital of Philadelphia (6701), Philadelphia, Pennsylvania, 19104-4318, United States

             Carol A. Vincent, CRNP, MSN, 215-590-2262, vincentc@email.chop.edu

Inscripciones abiertas

    Pitt CRS (1001), Pittsburgh, Pennsylvania, 15213, United States

             Christine A. Tripoli, BSN, RN, 412-647-0771, tripolica@upmc.edu

Inscripciones abiertas

Tennessee

    St. Jude/UTHSC CRS (6501), Memphis, Tennessee, 38105, United States

             Laura J. Utech, R.N., M.S.N., C.C.R.C., 1-901-595-3490, jill.utech@stjude.org

Inscripciones abiertas

    Regional Medical Center at Memphis (6502), Memphis, Tennessee, 38103, United States

             Nina K. Sublette, 901-448-1347, nina.sublette@stjude.org

Inscripciones abiertas

Texas

    Texas Children's Hosp. CRS (3801), Houston, Texas, 77030, United States

             Chivon D. Jackson, B.S.N., A.D.N., 1-832-824-1319, CDJACKSO@texaschildrenshospital.org

Inscripciones abiertas

Washington

    Univ of Washington Children's Hospital Seattle (5017), Seattle, Washington, 98105, United States

             Christin Johnson, 1-832-824-1319, cjonsson@uw.edu

Inscripciones abiertas

    University of Washington AIDS CRS (1401), Seattle, Washington, 98104, United States

             Joan Dragavon, 206-897-5210, dragavon@u.washington.edu

Inscripciones abiertas

    University of Washington NICHD CRS (5029), Seattle, Washington, 98105, United States

             Corry I. Venema-Weiss, M.S., ARNP, 206-884-7869, cvenema@u.washington.edu

Inscripciones abiertas

    Harborview Medical Center NICHD CRS (5027), Seattle, Washington, 98105, United States

             Suzanne Phelps, MS, 206-987-7869, suzanne.phelps@seattlechildrens.org

Inscripciones abiertas

    Hospital General de Agudos Buenos Aires Argentina NICHD CRS (5082), Buenos Aires, Washington, C1221ADC, Argentina

             Silvina Alejandra Ivalo, M.D., (5411)4931-5252, sivalo@hivramos.org.ar

Inscripciones abiertas

    Molepolole Prevention/Treatment Trials CRS (12702), Gaborone, Washington, C1221ADC, Botswana

             Molly P Holme, M.Sc., (5411)4931-5252, mpretori@hsph.harvard.edu

Inscripciones abiertas

    Gaborone Prevention/Treatment Trials CRS (12701), Gaborone, Washington, C1221ADC, Botswana

             Tebogo Kakhu, (011 267) 393-1146, tkakhu@bhp.org.bw

Inscripciones abiertas

CEP

    University Caxias do Sul Brazil NICHD CRS (5084), Caxias do Sul, CEP, 95070-560, Brazil

             Sérgio K Kato, (011 267) 393-1146, klmest@terra.com.br

Inscripciones abiertas

Minas Gerais

    SOM Federal University Minas Gerais Brazil NICHD CRS (5073), Belo Horizonte, Minas Gerais, 30130-100, Brazil

             Fabiana Kakehasi, M.D., (55-31) 3248 9822, kakehasi@medicina.ufmg.br

Inscripciones abiertas

Rio Grande do Sul

    Hospital Santa Casa NICHD CRS (5098), Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

             Debora Fernandes Coelho, PhD, RN, 55-51-3331-1765, deby.nh@terra.com.br

Inscripciones abiertas

    Hospital Nossa Senhora da Conceicao CRS (12201), Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

             Rita de Cassia Alves Lira, M.D., 55-513-3572603, rita.lira@globo.com

Inscripciones abiertas

    Universidade Federal do Rio de Janeiro NICHD CRS (5071), Rio de Janeiro, Rio Grande do Sul, 21941-912, Brazil

             Thalita Fernandes Abreu, 55 21 2562 6151, thalita.abreu@uol.com.br

Inscripciones abiertas

    Hospital dos Servidores Rio de Janeiro NICHD CRS (5072), Rio de Janeiro, Rio Grande do Sul, 20221-903, Brazil

             Jacqueline A De Menezes, M.D., M.Sc., 55 21 2233 0018, jacqueline@diphse.com.br

Inscripciones abiertas

    Hospital Geral De Nova Igaucu Brazil NICHD CRS (5097), Rio de Janeiro, Rio Grande do Sul, 26030, Brazil

             Gisely Goncalves Falco, R.N.N.P., 55 21 2667-6059, gisely.falco@gmail.com

Inscripciones abiertas

    Univ of Sao Paulo Brazil NICHD CRS (5074), Sao Paulo, Rio Grande do Sul, 14049-900, Brazil

             Marcia de Lima Isaac, M.D., 55 16 3621 7692, mdlisaac@hotmail.com

Inscripciones abiertas

    Les Centres GHESKIO CRS (30022), Port-au-Prince, Rio Grande do Sul, 6110, Haiti

             Jean W Pape, 55 16 3621 7692, jwpape@gheskio.org

Inscripciones abiertas

    San Juan City Hosp. PR NICHD CRS (5031), Rio Piedra, Rio Grande do Sul, 00927, Puerto Rico

             Lizbeth Fábregas -Troche, M.S., 630-787-764-3083, lfabregas@SanJuanCapital.com

Inscripciones abiertas

    University of Puerto Rico Pediatric HIV/AIDS Research (6601), San Juan, Rio Grande do Sul, 00936-5067, Puerto Rico

             Maritza Cruz-Rodriguez, B.A., 787-759-9595, maritza.cruz1@upr.edu

Inscripciones abiertas

Ratchathewi,

    Siriraj Hospital Mahidol University CRS (8251), Bangkok, Ratchathewi,, 10700, Thailand

             Kaewta Intalapaporn, 66-8-1620925, ikaewta@gmail.com

Inscripciones abiertas

    Bhumibol Adulyadej Hospital (8355), Bangkok, Ratchathewi,, 10700, Thailand

             Napawadee Impoolsup, M.D., 66-8-1620925, napa_im@hotmail.com

Inscripciones abiertas

    Prapokklao Hospital CRS (8354), Chantaburi, Ratchathewi,, 22000, Thailand

             Ubon Chanasit, (668) 983-48413, ubolchan@gmail.com

Inscripciones abiertas

    Chiang Mai University Pediatrics-Obstetrics CRS (20101), Chiang Mai, Ratchathewi,, 50200, Thailand

             Chintana Khamrong, MSc, 66-5-3945051, chintanak@rihes-cmu.org

Inscripciones abiertas

    Chiang Rai Regional Hospital CRS (8352), Chiang Rai, Ratchathewi,, 50200, Thailand

             Angkana Sophon, (668) 195-27498, angkanaphpt@yahoo.com

Inscripciones abiertas

    Chonburi Hosp. CRS (8356), Chonburi, Ratchathewi,, 20000, Thailand

             Ladda Argadamnuy, 66-3-8931000, ladda.argad@gmail.com

Inscripciones abiertas

    Phayao Provincial Hospital CRS (8353), Phayao, Ratchathewi,, 56000, Thailand

             Kunlaya Jansook, 66 54 409 300, jkunlaya@gmail.com

Inscripciones abiertas

Actualizado: 16 de junio del 2010

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