Examining Benefits of HAART Continuation in Postpartum Mothers

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00955968
First received: August 7, 2009
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Highly active antiretroviral therapy (HAART)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HAART Standard Version of the Promoting Maternal and Infant Survival Everywhere (PROMISE) Study

Resource links provided by NLM:


Further study details as provided by International Maternal Pediatric Adolescent AIDS Clinical Trials Group:

Primary Outcome Measures:
  • Morbidity and mortality [ Time Frame: Measured at baseline, after 4 and 12 weeks, and then every 3 months until study termination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Toxicity and side effects of medications [ Time Frame: Measured at baseline, after 4 and 12 weeks, and then every 3 months until study termination ] [ Designated as safety issue: Yes ]
  • Emergence of HIV resistance [ Time Frame: Measured at baseline, after 4 and 12 weeks, and then every 3 months until study termination ] [ Designated as safety issue: Yes ]
  • Medication adherence [ Time Frame: Measured at baseline, after 4 and 12 weeks, and then every 3 months until study termination ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Measured at baseline, after 4 and 12 weeks, and then every 3 months until study termination ] [ Designated as safety issue: No ]
  • Cost effectiveness and feasibility of treatment models [ Time Frame: Measured at baseline, after 4 and 12 weeks, and then every 3 months until study termination ] [ Designated as safety issue: Yes ]
  • Symptoms and lab values associated with clinical events [ Time Frame: Measured at baseline, after 4 and 12 weeks, and then every 3 months until study termination ] [ Designated as safety issue: No ]
  • Incidence of AIDS-defining illnesses and other select medical conditions [ Time Frame: Measured at baseline, after 4 and 12 weeks, and then every 3 months until study termination ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2000
Study Start Date: January 2010
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Continue HAART
Participants will continue receiving HAART after delivery of their babies.
Drug: Highly active antiretroviral therapy (HAART)
A standard combination of three or more HIV medications belonging to two or more drug classes
Active Comparator: Stop HAART
Participants will stop receiving HAART after delivery of their babies.
Drug: Highly active antiretroviral therapy (HAART)
A standard combination of three or more HIV medications belonging to two or more drug classes

Detailed Description:

Highly active antiretroviral therapy (HAART) is not recommended immediately for all HIV-infected people, only those who have significant illnesses or a cluster of differentiation 4 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years old or having attained the minimum age of independent consent, as defined by the local institutional review board (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 60 milliliters (mL)/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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955968

Contacts
Contact: Anne Coletti, MPH 919-544-7040 ext 11238 acoletti@fhi360.org

  Hide Study Locations
Locations
United States, Alabama
Univ. of Alabama Birmingham NICHD CRS (5096) Recruiting
Birmingham, Alabama, United States, 35294
Contact: Sharan Robbins, B.A.    205-996-6418    srobbins@peds.uab.edu   
Principal Investigator: Marilyn J Crain, M.P.H., M.D.         
United States, California
Miller Children's Hospital Long Beach (5093) Recruiting
Long Beach, California, United States, 90806
Contact: Susan Marks, RN    562-933-8093    smarks@memorialcare.org   
Principal Investigator: Audra Deveikis, MD         
Usc La Nichd Crs (5048) Recruiting
Los Angeles, California, United States, 90033
Contact: Eva A. Operskalski, PhD    323-226-5068    eva@usc.edu   
Principal Investigator: Andrea Kovacs, MD         
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601) Recruiting
Los Angeles, California, United States, 90095
Contact: Jin Kim, BS       jinkim@mednet.ucla.edu   
UCSD Mother, Child & Adolescent HIV Program(4601) Recruiting
San Diego, California, United States, 92103
Contact: Linda Proctor, RN, CNM, MSN    619-543-8080    lproctor@ucsd.edu   
Univ. of California San Francisco NICHD CRS (5091) Recruiting
San Francisco, California, United States, 94117
Contact: Ana Moreno    415-476-9373    morenoal@peds.ucsf.edu   
Principal Investigator: Diana W Wara, M.D.         
Harbor (UCLA) Medical Center NICHD CRS (5045) Recruiting
Torrance, California, United States, 90509
Contact: Judy Hayes, BSN, RN    310-781-3627    jhayes@labiomed.org   
Principal Investigator: Margaret Keller, MD         
Harbor Univeristy of California, Los Angeles (UCLA) Medical Center (603) Not yet recruiting
Torrance, California, United States, 90509
Contact: Judy Hayes, BSN, RN    310-781-3627    jhayes@labiomed.org   
Principal Investigator: Margaret Keller, MD         
United States, Colorado
Childrens Hospital (U. Colorado, Denver) NICHD CRS (5052) Recruiting
Denver, Colorado, United States, 80218-1088
Contact: Emily A. Barr, C.P.N.P    720-777-6752    barr.emily@tchden.org   
Principal Investigator: Elizabeth McFarland, M.D.         
United States, District of Columbia
Howard University Washington DC NICHD CRS (5044) Recruiting
Washington, District of Columbia, United States, 20060
Contact: Patricia Houston       phouston@howard.edu   
Principal Investigator: Sohail R. Rana, MD         
Washington Hospital Center NICHD CRS (5023) Recruiting
Washington, District of Columbia, United States, 200102931
Contact: Marla Shauer    202-877-5811    marla.shauer@medstar.net   
Principal Investigator: Menachem Miodovnik, M.D.         
United States, Florida
South Florida CDC Ft. Lauderdale NICHD (5055) Recruiting
Ft. Lauderdale, Florida, United States, 33316
Contact: Zulma Eysallenne, RN    954-728-1125    zeysallenne@browardhealth.org   
Principal Investigator: Amy Inman         
Univ. of Florida Jacksonville NICHD CRS (5051) Recruiting
Jacksonville, Florida, United States, 32209
Contact: Kathleen Thoma, M.P.H.    904-244-5331    kathleen.thoma@jax.ufl.edu   
Univ of Miami Pediatric/Perinatal HIV/AIDS (4201) Recruiting
Miami, Florida, United States, 33136
Contact: Patricia Bryan    305-243-4447    pbryan@med.miami.edu   
Principal Investigator: Charles D Mitchell, M.D.         
Tampa General Hospital NICHD CRS (5111) Recruiting
Tampa, Florida, United States, 33606-3475
Contact: Alicia Marion, A.R.N.P.       amarion@hsc.usf.edu   
Principal Investigator: Patricia J. Emmanuel, M.D.         
University of South Florida Tampa (5018) Recruiting
Tampa, Florida, United States, 33620
Contact: Tammy Meyers, B.S.    813-259-8786    Tmyers@health.usf.edu   
Principal Investigator: Patricia J. Emmanuel, M.D.         
United States, Illinois
Chicago Children's CRS(4001) Recruiting
Chicago, Illinois, United States, 60614
Contact: Eric Cagwin, R.N.    773-880-3669    ecagwin@childrensmemorial.org   
Rush University Medical Center ACTG CRS (2702) Recruiting
Chicago, Illinois, United States, 60612
Contact: Janice Fritsche, MS    312-942-4810    jfrits@rush.edu   
Principal Investigator: Beverly E. Sha, MD         
Rush University Cook County Hospital NICHD CRS (5083) Recruiting
Chicago, Illinois, United States, 60612
Contact: Maureen Haak, RN, MSN    312-572-4541    maureen_haak@rush.edu   
Principal Investigator: James B. McAuley, MD, MPH         
United States, Louisiana
Tulane University (5095) Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Patricia Reilly, RN, CCRC    504-988-3804    preilly@tulane.edu   
Principal Investigator: Russell B. Van Dyke, MD         
United States, Maryland
Johns Hopkins University NICHD CRS (5092) Recruiting
Baltimore, Maryland, United States, 21287
Contact: Todd Noletto, MPH    443-287-9040    tnolett1@jhmi.edu   
Principal Investigator: Jonathan M. Ellen, M.D.         
Univ of Maryland Baltimore NICHD CRS (5094) Recruiting
Baltimore, Maryland, United States, 21201
Contact: Mary MacFadden    410-706-8933    mmacfadd@peds.umaryland.edu   
United States, Massachusetts
Boston Medical Center Ped. HIV Program NICHD CRS (5011) Recruiting
Boston, Massachusetts, United States, 02118
Contact: Debra McLaud, RN    617-414-3632    demclaud@bmc.org   
Principal Investigator: Stephen I. Pelton, MD         
Children's Hospital of Boston (5009) Recruiting
Boston, Massachusetts, United States, 02115
Contact: Catherine Kneut, RN, MS, CRNP    617-355-7879    catherine.kneut@childrens.harvard.edu   
Principal Investigator: Sandra K. Burchett, MD, MS         
WNE Maternal Pediatric Adolescent AIDS CRS (7301) Recruiting
Worcester, Massachusetts, United States, 01605
Contact: Margaret McManus    508-856-5589    margaret.mcmanus@umassmed.edu   
Principal Investigator: Katherine Luzuriaga, MD         
United States, Michigan
Hutzel Hospital NICHD CRS (5089) Recruiting
Detroit, Michigan, United States, 48201
Contact: Tamika Watson, R.N., C.N.M., MAOM    1-313-993-3429    twatson@med.wayne.edu   
Children's Hospital of Michigan NICHD CRS 5041 Recruiting
Detroit, Michigan, United States, 48201
Contact: Ulyssa Hancock, R.N., B.S.N.    313-745-9204    uhancock@dmc.org   
Wayne State University/Children's Hospital of Michigan NICHD CRS (5041) Recruiting
Detroit, Michigan, United States, 48201
Contact: Ulyssa Hancock, R.N., B.S.N.    313-745-9204    uhancock@dmc.org   
Principal Investigator: Chokechai Rongkavilit, MD         
United States, New Jersey
NJ Med School CRS (2802) Recruiting
Newark, New Jersey, United States, 07103
Contact: Linda Bettica, B.S.N.    (973) 972-3119    betticlm@umdnj.edu   
Principal Investigator: Arlene D. Bardeguez, M.D., M.P.H., F.A.C.O.G.         
United States, New York
Jacobi Med. Ctr. Bronx NICHD CRS (5013) Recruiting
Bronx, New York, United States, 10461
Contact: Marlene Burey    718-918-4783    marlene.burey@nbhn.net   
Bronx Lebanon Hospital Center (31469) Not yet recruiting
Bronx, New York, United States, 10457
Contact: Caroline Nubel    718-960-1020    cnubel@bronxleb.org   
Bronx-Lebanon Hospital IMPAACT CRS (6901) Recruiting
Bronx, New York, United States, 10457
Contact: Mary-Elizabeth Vachon, MPH    718-960-1016    mvachon@bronxleb.org   
Principal Investigator: Murli U. Purswani, MD         
Columbia IMPAACT CRS (4101) Recruiting
New York, New York, United States, 10032
Contact: Alice Higgins, R.N., M.P.A.    212-305-8181    higgina@nyp.org   
Principal Investigator: Philip S. LaRussa, M.D.         
Metropolitan Hospital (5003) Recruiting
New York, New York, United States, 10029
Contact: Santa Paul, MD    212-423-8630    santa.paul@nychhc.org   
Principal Investigator: Marukh Bamji, MD         
New York University NY (5012) Recruiting
New York, New York, United States, 10016
Contact: Joseph Bertran    212-263-8198    Joseph.bertran@nyumc.org   
Principal Investigator: William Borkowsky, M.D.         
SUNY Stony Brook (5040) Recruiting
Stony Brook, New York, United States, 11794-8111
Contact: Denise M Ferraro, M.S., FNP-BC    631-444-8225    denise.ferraro@stonybrook.edu   
Principal Investigator: Sharon A Nachman, M.D.         
United States, North Carolina
Unc Aids Crs (3201) Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Cheryl J. Marcus, BSN, RN    919-843-8761    cjm@med.unc.edu   
Principal Investigator: David A. Wohl, MD         
Duke University Medical Center (DUMC) Pediatric CRS (4701) Recruiting
Durham, North Carolina, United States, 27710
Contact: John Swetnam    919-668-4847    swetnam@duke.edu   
Principal Investigator: Coleen K. Cunningham, MD         
Wake County Health and Human Services CRS (30076) Recruiting
Raleigh, North Carolina, United States, 27630
Contact: Susan Pedersen    919-966-6713    spederse@med.unc.edu   
Principal Investigator: Kristine Patterson, MD         
United States, Ohio
Ohio State University AIDS CRS (2301) Recruiting
Columbus, Ohio, United States, 43210
Contact: Todd L. Lusch    614-293-5282    todd.lusch@osumc.edu   
Principal Investigator: Susan L. Koletar, MD         
United States, Pennsylvania
Childrens Hospital of Philadelphia (6701) Recruiting
Philadelphia, Pennsylvania, United States, 19104-4318
Contact: Carol A. Vincent, CRNP, MSN    215-590-2262    vincentc@email.chop.edu   
Pitt CRS (1001) Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Christine A. Tripoli, BSN, RN    412-647-0771    tripolica@upmc.edu   
Principal Investigator: Sharon A. Riddler, MD, MPH         
United States, Tennessee
St. Jude/UTHSC CRS (6501) Recruiting
Memphis, Tennessee, United States, 38105
Contact: Laura J. Utech, R.N., M.S.N., C.C.R.C.    1-901-595-3490    jill.utech@stjude.org   
Regional Medical Center at Memphis (6502) Recruiting
Memphis, Tennessee, United States, 38103
Contact: Nina K. Sublette    901-448-1347    nina.sublette@stjude.org   
Principal Investigator: Edwin Thorpe, MD         
United States, Texas
Texas Children's Hosp. CRS (3801) Recruiting
Houston, Texas, United States, 77030
Contact: Chivon D. Jackson, B.S.N., A.D.N.    1-832-824-1319    CDJACKSO@texaschildrenshospital.org   
United States, Washington
Univ of Washington Children's Hospital Seattle (5017) Recruiting
Seattle, Washington, United States, 98105
Contact: Christin Johnson       cjonsson@uw.edu   
University of Washington AIDS CRS (1401) Recruiting
Seattle, Washington, United States, 98104
Contact: Joan Dragavon    206-897-5210    dragavon@u.washington.edu   
University of Washington NICHD CRS (5029) Recruiting
Seattle, Washington, United States, 98105
Contact: Corry I. Venema-Weiss, M.S., ARNP    206-884-7869    cvenema@u.washington.edu   
Principal Investigator: Jane Hitti, M.D., MPH         
Harborview Medical Center NICHD CRS (5027) Recruiting
Seattle, Washington, United States, 98105
Contact: Suzanne Phelps, MS    206-987-7869    suzanne.phelps@seattlechildrens.org   
Principal Investigator: Jane Hitti, M.D         
Argentina
Hospital General de Agudos Buenos Aires Argentina NICHD CRS (5082) Recruiting
Buenos Aires, Argentina, C1221ADC
Contact: Silvina Alejandra Ivalo, M.D.    (5411)4931-5252    sivalo@hivramos.org.ar   
Principal Investigator: Marcelo H. Losso, M.D.         
Botswana
Molepolole Prevention/Treatment Trials CRS (12702) Recruiting
Gaborone, Botswana
Contact: Molly P Holme, M.Sc.       mpretori@hsph.harvard.edu   
Gaborone Prevention/Treatment Trials CRS (12701) Recruiting
Gaborone, Botswana
Contact: Tebogo Kakhu    (011 267) 393-1146    tkakhu@bhp.org.bw   
Principal Investigator: Anthony C. Ogwu, B.S.M.B.         
Brazil
University Caxias do Sul Brazil NICHD CRS (5084) Recruiting
Caxias do Sul, CEP, Brazil, 95070-560
Contact: Sérgio K Kato       klmest@terra.com.br   
SOM Federal University Minas Gerais Brazil NICHD CRS (5073) Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30130-100
Contact: Fabiana Kakehasi, M.D.    (55-31) 3248 9822    kakehasi@medicina.ufmg.br   
Principal Investigator: Jorge Pinto, M.D.,D.Sc.         
Hospital Santa Casa NICHD CRS (5098) Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
Contact: Debora Fernandes Coelho, PhD, RN    55-51-3331-1765    deby.nh@terra.com.br   
Principal Investigator: Regis Kreitchmann, M.D,Ph.D.         
Hospital Nossa Senhora da Conceicao CRS (12201) Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
Contact: Rita de Cassia Alves Lira, M.D.    55-513-3572603    rita.lira@globo.com   
Principal Investigator: Breno Riegel Santos, M.D.         
Universidade Federal do Rio de Janeiro NICHD CRS (5071) Recruiting
Rio de Janeiro, Brazil, 21941-912
Contact: Thalita Fernandes Abreu    55 21 2562 6151    thalita.abreu@uol.com.br   
Principal Investigator: Ricardo Hugo S. Oliveira, M.D.         
Hospital dos Servidores Rio de Janeiro NICHD CRS (5072) Recruiting
Rio de Janeiro, Brazil, 20221-903
Contact: Jacqueline A De Menezes, M.D., M.Sc.    55 21 2233 0018    jacqueline@diphse.com.br   
Contact: Leon C Sidi, M.D.    55-212-203-2013    leon@diphse.com.br   
Principal Investigator: Esau Custódio João (Filho), M.D.         
Hospital Geral De Nova Igaucu Brazil NICHD CRS (5097) Recruiting
Rio de Janeiro, Brazil, 26030
Contact: Gisely Goncalves Falco, R.N.N.P.    55 21 2667-6059    gisely.falco@gmail.com   
Principal Investigator: Jose H. da Silva Pilotto, M.D.         
Univ of Sao Paulo Brazil NICHD CRS (5074) Recruiting
Sao Paulo, Brazil, 14049-900
Contact: Marcia de Lima Isaac, M.D.    55 16 3621 7692    mdlisaac@hotmail.com   
Principal Investigator: Marisa M. Mussi-Pinhata, M.D., Ph.D.         
Haiti
Les Centres GHESKIO CRS (30022) Recruiting
Port-au-Prince, Haiti, 6110
Contact: Jean W Pape       jwpape@gheskio.org   
Puerto Rico
San Juan City Hosp. PR NICHD CRS (5031) Recruiting
Rio Piedra, Puerto Rico, 00927
Contact: Lizbeth Fábregas -Troche, M.S.    630-787-764-3083    lfabregas@SanJuanCapital.com   
University of Puerto Rico Pediatric HIV/AIDS Research (6601) Recruiting
San Juan, Puerto Rico, 00936-5067
Contact: Maritza Cruz-Rodriguez, B.A.    787-759-9595 ext 229    maritza.cruz1@upr.edu   
Principal Investigator: Irma L. Febo Rodriguez, M.D.         
Thailand
Siriraj Hospital Mahidol University CRS (8251) Recruiting
Bangkok, Ratchathewi,, Thailand, 10700
Contact: Kaewta Intalapaporn    66-8-1620925    ikaewta@gmail.com   
Bhumibol Adulyadej Hospital (8355) Recruiting
Bangkok, Thailand
Contact: Napawadee Impoolsup, M.D.       napa_im@hotmail.com   
Principal Investigator: Napawadee Impoolsup, M.D.         
Prapokklao Hospital CRS (8354) Recruiting
Chantaburi, Thailand, 22000
Contact: Ubon Chanasit    (668) 983-48413    ubolchan@gmail.com   
Principal Investigator: Prapap Yuthavisuthi, M.D.         
Chiang Mai University Pediatrics-Obstetrics CRS (20101) Recruiting
Chiang Mai, Thailand, 50200
Contact: Chintana Khamrong, MSc    66-5-3945051 ext 446    chintanak@rihes-cmu.org   
Chiang Rai Regional Hospital CRS (8352) Recruiting
Chiang Rai, Thailand
Contact: Angkana Sophon    (668) 195-27498    angkanaphpt@yahoo.com   
Principal Investigator: Pacharee Kantipong, M.D.         
Chonburi Hosp. CRS (8356) Recruiting
Chonburi, Thailand, 20000
Contact: Ladda Argadamnuy    66-3-8931000    ladda.argad@gmail.com   
Phayao Provincial Hospital CRS (8353) Recruiting
Phayao, Thailand, 56000
Contact: Kunlaya Jansook    66 54 409 300    jkunlaya@gmail.com   
Principal Investigator: Guttiga Halue, M.D.         
Sponsors and Collaborators
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Investigators
Study Chair: Judith S. Currier, MD, MS UCLA CARE Center
  More Information

No publications provided

Responsible Party: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00955968     History of Changes
Other Study ID Numbers: IMPAACT 1077HS, U01AI068632
Study First Received: August 7, 2009
Last Updated: June 26, 2014
Health Authority: United States: Federal Government

Keywords provided by International Maternal Pediatric Adolescent AIDS Clinical Trials Group:
Perinatal Transmission of HIV
HAART
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 20, 2014