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Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00042289
First received: July 26, 2002
Last updated: October 16, 2014
Last verified: October 2014
  Purpose

The purpose of this study is to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study will also evaluate the PKs of certain ARVs in postpartum women before and after starting hormonal contraceptives. The PKs of these drugs will be evaluated by measuring the amount of medicine present in blood and/or vaginal secretions.


Condition Intervention Phase
HIV Infections
Drug: Current ARV medications
Drug: Current TB medications
Drug: Current hormonal contraceptive medications
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Drug parameter: Area under the curve from 0 to 12 hours (AUC 0-12) [ Time Frame: Measured at intensive PK visit ] [ Designated as safety issue: No ]
    Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester; 3rd trimester; and either 2 to 6 weeks, 2 to 8 weeks, or 6 to 12 weeks postpartum.

  • Drug parameter: Area under the curve from 0 to 24 hours (AUC 0-24) [ Time Frame: Measured at intensive PK visit ] [ Designated as safety issue: No ]
    Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester; 3rd trimester; and either 2 to 6 weeks, 2 to 8 weeks, or 6 to 12 weeks postpartum.

  • Drug parameter: Maximum concentration (Cmax) [ Time Frame: Measured at intensive PK visit ] [ Designated as safety issue: No ]
    Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester; 3rd trimester; and either 2 to 6 weeks, 2 to 8 weeks, or 6 to 12 weeks postpartum.

  • Drug parameter: Pre-dose concentration (Cdose) [ Time Frame: Measured at intensive PK visit ] [ Designated as safety issue: No ]
    Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester; 3rd trimester; and either 2 to 6 weeks, 2 to 8 weeks, or 6 to 12 weeks postpartum.

  • Drug parameter: Minimum concentration (Cmin) [ Time Frame: Measured at intensive PK visit ] [ Designated as safety issue: No ]
    Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester; 3rd trimester; and either 2 to 6 weeks, 2 to 8 weeks, or 6 to 12 weeks postpartum.

  • Drug parameter: Time after administration of drug when maximum plasma concentration is reached (Tmax) [ Time Frame: Measured at intensive PK visit ] [ Designated as safety issue: No ]
    Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester; 3rd trimester; and either 2 to 6 weeks, 2 to 8 weeks, or 6 to 12 weeks postpartum.

  • Drug parameter: Clearance over systemic availability (Cl/F) [ Time Frame: Measured at intensive PK visit ] [ Designated as safety issue: No ]
    Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester; 3rd trimester; and either 2 to 6 weeks, 2 to 8 weeks, or 6 to 12 weeks postpartum.

  • Drug parameter: Volume of distribution over systemic availability (V/F) [ Time Frame: Measured at intensive PK visit ] [ Designated as safety issue: No ]
    Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester; 3rd trimester; and either 2 to 6 weeks, 2 to 8 weeks, or 6 to 12 weeks postpartum.

  • Drug parameter: Half-life (t1/2) [ Time Frame: Measured at intensive PK visit ] [ Designated as safety issue: No ]
    Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester; 3rd trimester; and either 2 to 6 weeks, 2 to 8 weeks, or 6 to 12 weeks postpartum.

  • ARV concentrations in vaginal secretions [ Time Frame: Measured at intensive PK visit ] [ Designated as safety issue: No ]
    Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester; 3rd trimester; and either 2 to 6 weeks, 2 to 8 weeks, or 6 to 12 weeks postpartum.

  • ARV concentrations in plasma [ Time Frame: Measured at intensive PK visit ] [ Designated as safety issue: No ]
    Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester; 3rd trimester; and either 2 to 6 weeks, 2 to 8 weeks, or 6 to 12 weeks postpartum.

  • For contraceptives: plasma concentration [ Time Frame: Measured at 2-12 weeks postpartum (prior to contraceptive initiation) and again 6-7 weeks after contraceptive initiation. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ratio of cord blood concentration to maternal blood concentration [ Time Frame: Measured at time of delivery ] [ Designated as safety issue: No ]
  • Ratio of unbound/total drug concentrations [ Time Frame: Measured at time of delivery ] [ Designated as safety issue: No ]
    Ratio will be measured for the highly-bound ARVs, including atazanavir, darunavir, efavirenz, etravirine, lopinavir, nelfinavir, and tipranavir

  • Rate of detection of study drugs in vaginal secretions [ Time Frame: Measured at intensive PK visit ] [ Designated as safety issue: No ]
    Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester; 3rd trimester; and either 2 to 6 weeks, 2 to 8 weeks, or 6 to 12 weeks postpartum.

  • Ratio of vaginal drug concentrations to simultaneous blood concentrations [ Time Frame: Measured at intensive PK visit ] [ Designated as safety issue: No ]
    Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester; 3rd trimester; and either 2 to 6 weeks, 2 to 8 weeks, or 6 to 12 weeks postpartum.

  • Rate of detection of HIV RNA/DNA in vaginal secretions and comparison to level in blood [ Time Frame: Measured at intensive PK visit ] [ Designated as safety issue: No ]
    Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester; 3rd trimester; and either 2 to 6 weeks, 2 to 8 weeks, or 6 to 12 weeks postpartum.

  • ARV exposure (as measured by area under the curve or other PK parameters) during pregnancy and postpartum according to genotype [ Time Frame: Measured at intensive PK visit ] [ Designated as safety issue: No ]
    Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester; 3rd trimester; and either 2 to 6 weeks, 2 to 8 weeks, or 6 to 12 weeks postpartum.

  • Adverse events of grade 3 or higher [ Time Frame: Measured through 24 weeks postpartum ] [ Designated as safety issue: Yes ]
  • Infant neurological events of grade 1 or higher [ Time Frame: Measured through 24 weeks of life ] [ Designated as safety issue: Yes ]
  • Adverse pregnancy outcome: preterm birth [ Time Frame: Measured through delivery ] [ Designated as safety issue: Yes ]
  • Adverse pregnancy outcome: low birth weight [ Time Frame: Measured at delivery ] [ Designated as safety issue: Yes ]
  • Adverse pregnancy outcome: fetal demise [ Time Frame: Measured through 24 weeks postpartum ] [ Designated as safety issue: Yes ]
  • Adverse pregnancy outcome: congenital anomalies [ Time Frame: Measured through 24 weeks of life ] [ Designated as safety issue: Yes ]
  • Infant HIV infection status [ Time Frame: Measured through 24 weeks of life ] [ Designated as safety issue: No ]

Estimated Enrollment: 1300
Study Start Date: March 2003
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Women taking ARVs without TB treatment
HIV-infected pregnant women will be assigned to this arm if receiving one or more of the following ARV drugs/drug combinations but not receiving TB treatment: darunavir/ritonavir, etravirine, elvitegravir/cobicistat, dolutegravir, tenofovir alafenamide fumarate (TAF), efavirenz, or lopinavir/ritonavir (with dose information specified in the protocol).
Drug: Current ARV medications
Pregnant women will continue on ARV medications as prescribed by their clinicians.
Experimental: Women taking ARVs with TB treatment
HIV-infected pregnant women will be assigned to this arm if receiving efavirenz, lopinavir/ritonavir, or nevirapine and rifampicin-containing TB treatment with at least one of the following TB drugs: ethambutol, isoniazid, or pyrazinamide (with dose information specified in the protocol).
Drug: Current ARV medications
Pregnant women will continue on ARV medications as prescribed by their clinicians.
Drug: Current TB medications
Pregnant women will continue on TB medications as prescribed by their clinicians.
Experimental: Women taking no ARVs with TB treatment
HIV-uninfected pregnant women will be assigned to this arm if receiving at least two of the following drugs: ethambutol, isoniazid, pyrazinamide, or rifampicin (with dose information specified in the protocol).
Drug: Current TB medications
Pregnant women will continue on TB medications as prescribed by their clinicians.
Experimental: Women taking ARVs with postpartum hormonal contraceptives
HIV- infected women 2-12 weeks postpartum will be assigned to this arm if receiving one of the following ARV drug combinations and starting postpartum contraceptives: atazanavir/ritonavir/tenofovir and starting combined oral contraceptives formulated with ethinyl estradiol, efavirenz and starting combined oral contraceptives formulated with ethinyl estradiol, or atazanavir/ritonavir/tenofovir and starting etonogestrel implant, or efavirenz and starting etonogestrel implant (dose information specified in the protocol).
Drug: Current ARV medications
Pregnant women will continue on ARV medications as prescribed by their clinicians.
Drug: Current hormonal contraceptive medications
Pregnant women will continue on hormonal contraceptive medications as prescribed by their clinicians.

Detailed Description:

Pregnant women experience unique physiological changes that may result in clinically significant alterations in drug PKs. Unfortunately, there have been few clinical trials to study the PKs of ARV, TB, and hormonal contraceptive drugs in pregnant women. The development of appropriate dosing regimens for the HIV-infected pregnant woman is critical to the health of both mother and fetus. Overdosing may lead to maternal adverse events and increased risk of fetal toxicity, while underdosing may lead to inadequate virologic control, increased risk of developing drug resistance mutations, and a higher rate of perinatal HIV transmission. This study will evaluate the PKs of ARVs used during pregnancy; evaluate TB drugs used during pregnancy, both in women who are HIV-positive and also taking ARVs and in women who are HIV-negative and not taking ARVs; and evaluate the PKs of hormonal contraceptive medications taken along with ARVs.

There will be four main groups of study arms: HIV-infected pregnant women taking ARVs without TB treatment, HIV-infected pregnant women taking ARVs with TB treatment, HIV-uninfected pregnant women taking no ARVs with TB treatment, and HIV-infected pregnant women taking ARVs with postpartum hormonal contraceptives. Participants will not receive medications through this study—they will continue on ARV, TB, and/or contraceptive medications prescribed by their health care providers.

Women who are 20 0/7 weeks to 37 6/7 weeks pregnant will be enrolled in this study and will remain in the study for 24 weeks after delivery. Postpartum women will be enrolled at 2 to 12 weeks after delivery and followed until 6 to 7 weeks after starting contraceptives. Infants will be followed until 24 weeks of life. At all study visits, participants will undergo a medical history, a physical exam, and blood collection. At some visits, women in some arms will undergo a vaginal swab. Blood collection from the mother and the detached umbilical cord will occur during delivery. Intensive PK sampling will be performed at study visits during the second and third trimester of pregnancy and at various other times during the study, depending on the study arm. Additional study visits may occur depending on the ARV drug regimen prescribed.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Maternal Inclusion Criteria:

  • Participant must belong to one of the following 4 groups:

    1. HIV-infected pregnant woman at least 20 weeks gestation and NOT on TB treatment, receiving one or more of the ARV drugs/drug combinations specified in the protocol
    2. HIV-infected pregnant woman at least 20 weeks gestation receiving one of the ARV drugs/drug combinations specified in the protocol and rifampicin-containing TB treatment with at least one of the TB drugs, specified in the protocol, at study entry
    3. HIV-uninfected pregnant woman greater than 20 weeks gestation receiving at least two TB drugs, specified in the protocol, at study entry
    4. HIV-infected woman 2 to 12 weeks (14 to 84 days) post-delivery receiving one of the ARV drug combinations listed in the protocol AND starting postpartum contraceptives as listed in the protocol
  • The woman must be stable on the ARV drug/drug combination and/or TB drug combination for at least 2 weeks prior to PK sampling
  • If a woman is receiving a specific generic ARV formulation, the protocol team has approved this formulation
  • HIV-infected pregnant women must be planning to continue on current ARV regimen until postpartum PK sampling is completed
  • For HIV-infected women: confirmed HIV infection, documented by positive results from two samples collected at different time points prior to study entry. More information on this criterion can be found in the protocol.
  • HIV-uninfected pregnant women must have documented negative HIV antibody test during current pregnancy
  • Participants enrolling in the 3rd trimester must enroll by 34 6/7 weeks gestation
  • Participant can provide legal informed consent per local regulations
  • If a woman has completed this study and becomes pregnant again, she may re-enroll in the study only if she is enrolled in a different arm than that studied during her initial enrollment

Maternal Exclusion Criteria:

  • Women on medicines known to interfere with absorption, metabolism, or clearance of the ARV drug being evaluated (see protocol for more information). Rifampicin is permitted for women being evaluated for TB and ARV drug interactions.
  • If pregnant, carrying multiple fetuses
  • Clinical or laboratory toxicity that, in the opinion of the site investigator, would be likely to require a change in the medicine regimen during the period of study

Infant Enrollment Criteria:

  • All infants of mothers enrolled during pregnancy (meeting criteria specified above) are enrolled, in utero, immediately after maternal enrollment. Note: Mother-infant pairs enrolled under version 8.0 of the protocol and who have not reached their final study visit at the time of site conversion to version 9.0 must consent to version 9.0 and continue in follow-up through 24 weeks undergoing version 9.0 visit procedures.

Infant Requirements for Washout Pharmacokinetic Sampling:

  • Born to HIV-infected mother enrolled during pregnancy in an ARV arm (does not include infants born to HIV-uninfected mothers receiving TB drugs)
  • Birth weight greater than 1000 grams
  • Is NOT receiving disallowed medications described in Section 7 of the protocol
  • Does not have any severe congenital malformation or other medical condition not compatible with life or that would interfere with study participation or interpretation, as judged by the site investigator
  • Born after singleton delivery (not after multiple birth)
  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: NCT00042289

Contacts
Contact: Emily F. Demske 301-628-3322

  Hide Study Locations
Locations
United States, Alabama
UAB, Dept. of Ped., Div. of Infectious Diseases Withdrawn
Birmingham, Alabama, United States, 35233
UAB Pediatric Infectious Diseases CRS Completed
Birmingham, Alabama, United States, 35233
Univ. of South Alabama College of Medicine, Southeast Ped. ACTU Withdrawn
Mobile, Alabama, United States, 36604
United States, California
Usc La Nichd Crs Recruiting
Alhambra, California, United States, 91803
Contact: Eva A. Operskalski, PhD    626-457-5820    eva@usc.edu   
University of California, UC San Diego CRS Recruiting
La Jolla, California, United States, 92093-0672
Contact: Kimberly Norris, B.S.N., R.N.    858-534-9204    kanorris@ucsd.edu   
Long Beach Memorial Med. Ctr., Miller Children's Hosp. Withdrawn
Long Beach, California, United States, 90806
Miller Children's Hosp. Long Beach CA NICHD CRS Recruiting
Long Beach, California, United States, 90806
Contact: Janielle Jackson-Alvarez    562-933-8666    jjackson-alvarez@memorialcare.org   
David Geffen School of Medicine at UCLA NICHD CRS Recruiting
Los Angeles, California, United States, 90095-1752
Contact: Michele F. Carter, B.S., R.N.    310-206-6369    mfcarter@mednet.ucla.edu   
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS Withdrawn
Los Angeles, California, United States, 90095-1752
Univ. of California San Francisco NICHD CRS Completed
San Francisco, California, United States, 94143
UCSF Pediatric AIDS CRS Withdrawn
San Francisco, California, United States, 94110
Harbor UCLA Medical Ctr. NICHD CRS Recruiting
Torrance, California, United States, 90502
Contact: Judy Hayes, BSN, RN    310-781-3627    jhayes@labiomed.org   
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases Withdrawn
Torrance, California, United States, 90509
United States, Colorado
Univ. of Colorado Denver NICHD CRS Recruiting
Aurora, Colorado, United States, 80045
Contact: Emily Barr, C.P.N.P.    720-777-6752    emily.barr@childrenscolorado.org   
United States, Connecticut
Univ. of Connecticut Health Ctr., Dept. of Ped. Withdrawn
Farmington, Connecticut, United States, 06030-6203
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease Completed
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Children's National Med. Ctr. Washington DC NICHD CRS Withdrawn
Washington, District of Columbia, United States, 20010
Washington Hosp. Ctr. NICHD CRS Completed
Washington, District of Columbia, United States, 20010
United States, Florida
Univ. of Florida Jacksonville NICHD CRS Completed
Jacksonville, Florida, United States, 32209
Pediatric Perinatal HIV Clinical Trials Unit CRS Recruiting
Miami, Florida, United States, 33136
Contact: Patricia Bryan, R.N.    305-243-2700    pbryan@med.miami.edu   
Univ. of Miami Miller School of Medicine - Jackson Memorial Hosp. Withdrawn
Miami, Florida, United States, 33136-1096
USF - Tampa NICHD CRS Completed
Tampa, Florida, United States, 33606
United States, Georgia
Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases Completed
Augusta, Georgia, United States, 30912
Columbus Regional HealthCare System, The Med. Ctr. Withdrawn
Columbus, Georgia, United States, 31901
United States, Illinois
Rush Univ. Cook County Hosp. Chicago NICHD CRS Recruiting
Chicago, Illinois, United States, 60612
Contact: Maureen McNichols, RN, MSN    312-572-4541    maureen_mcnichols@rush.edu   
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease Withdrawn
Chicago, Illinois, United States, 60637
Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program Completed
Chicago, Illinois, United States, 60608
Ann & Robert H. Lurie Children's Hospital of Chicago (LCH) CRS Recruiting
Chicago, Illinois, United States, 60614-3393
Contact: Margaret Ann Sanders, MPH    312-227-8275    msanders@luriechildrens.org   
Univ. of Illinois College of Medicine at Chicago, Dept. of Peds. Completed
Chicago, Illinois, United States, 60612
Cook County Hosp. Withdrawn
Chicago, Illinois, United States, 60612
United States, Louisiana
Tulane Univ. Health Science Ctr., Tulane Univ. Hosp. & Clinic Withdrawn
New Orleans, Louisiana, United States, 70112
Tulane Univ. New Orleans NICHD CRS Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Yvette Luster, R.N.    504-988-3804    yluster@tulane.edu   
Tulane/LSU Maternal/Child CRS Withdrawn
New Orleans, Louisiana, United States, 70112
United States, Maryland
Johns Hopkins Univ. Baltimore NICHD CRS Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Thuy Anderson, R.N., B.S.N.    443-287-8942    tander34@jhmi.edu   
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology Withdrawn
Baltimore, Maryland, United States, 29425-3312
Univ. of Maryland Baltimore NICHD CRS Completed
Baltimore, Maryland, United States, 21201
United States, Massachusetts
BMC, Div. of Ped Infectious Diseases Withdrawn
Boston, Massachusetts, United States, 02118
Boston Medical Center Ped. HIV Program NICHD CRS Recruiting
Boston, Massachusetts, United States, 02118
Contact: Debra McLaud, RN    617-414-5813    demclaud@bmc.org   
Brigham and Women's Hosp., Div. of Infectious Disease Withdrawn
Boston, Massachusetts, United States, 02115
Children's Hosp. of Boston NICHD CRS Completed
Boston, Massachusetts, United States, 02115
Baystate Health, Baystate Med. Ctr. Completed
Springfield, Massachusetts, United States, 01199
WNE Maternal Pediatric Adolescent AIDS CRS Completed
Worcester, Massachusetts, United States, 01605
United States, Michigan
Children's Hospital of Michigan NICHD CRS Completed
Detroit, Michigan, United States, 48201
United States, Missouri
Washington Univ. School of Medicine at St. Louis, St. Louis Children's Hosp. Withdrawn
St. Louis, Missouri, United States, 63110
United States, New Jersey
Rutgers - New Jersey Medical School CRS Completed
Newark, New Jersey, United States, 07103
United States, New York
Bronx-Lebanon Hospital Center NICHD CRS Recruiting
Bronx, New York, United States, 10457
Contact: Jenny Gutierrez, M.D.    718-960-1010    jgutierr@bronxleb.org   
Bronx-Lebanon CRS Not yet recruiting
Bronx, New York, United States, 10457
Contact: Mary-Elizabeth Vachon, MPH    718-960-1016    mvachon@bronxleb.org   
Jacobi Med. Ctr. Bronx NICHD CRS Recruiting
Bronx, New York, United States, 10461
Contact: Marlene Burey    718-918-4783    marlene.burey@nbhn.net   
Jacobi Med. Ctr. Not yet recruiting
Bronx, New York, United States, 10461
Nyu Ny Nichd Crs Completed
New York, New York, United States, 10016
Metropolitan Hosp. NICHD CRS Recruiting
New York, New York, United States, 10029
Contact: Santa Paul, MD    212-423-8630    santa.paul@nychhc.org   
Columbia IMPAACT CRS Recruiting
New York, New York, United States, 10032
Contact: Alice Higgins, RN, MPA    212-305-8181    ah310@columbia.edu   
SUNY Stony Brook NICHD CRS Recruiting
Stony Brook, New York, United States, 11794-8111
Contact: Denise Ferraro    631-444-8225    denise.ferraro@stonybrook.edu   
SUNY Upstate Med. Univ., Dept. of Peds. Withdrawn
Syracuse, New York, United States, 13210
United States, North Carolina
DUMC Ped. CRS Completed
Durham, North Carolina, United States, 27710
United States, Pennsylvania
The Children's Hosp. of Philadelphia IMPAACT CRS Withdrawn
Philadelphia, Pennsylvania, United States, 19104
Philadelphia IMPAACT Unit CRS Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Carol A. Vincent, Ph.D., C.R.N.P., M.S.N.    215-590-2262    vincentc@email.chop.edu   
Hahnemann Univ. Hosp. Withdrawn
Philadelphia, Pennsylvania, United States, 19102
United States, Tennessee
Regional Med. Ctr. at Memphis Completed
Memphis, Tennessee, United States, 38103
St. Jude Children's Research Hospital CRS Recruiting
Memphis, Tennessee, United States, 38105-3678
Contact: Laura J. Utech, R.N., M.S.N., C.C.R.C.    1-901-595-3490    jill.utech@stjude.org   
Vanderbilt Univ. Med. Ctr., Div. of Ped. Infectious Diseases Withdrawn
Nashville, Tennessee, United States, 37232-2581
United States, Texas
Texas Children's Hospital CRS Recruiting
Houston, Texas, United States, 77030-2399
Contact: Chivon D. McMullen-Jackson, B.S.N., A.D.N., R.N.    832-824-1339    cdmcmull@texaschildrens.org   
United States, Washington
Univ. of Washington NICHD CRS Not yet recruiting
Seattle, Washington, United States, 98195
Contact: Amanda Robson Nuss, B.S.    206-884-1535    amanda.robson@seattlechildrens.org   
UW School of Medicine - CHRMC Not yet recruiting
Seattle, Washington, United States, 98105
Seattle Children's Research Institute CRS Recruiting
Seattle, Washington, United States, 98101
Contact: Amanda Robson Nuss, B.S.    206-884-1535    amanda.robson@seattlechildrens.org   
UW Medicine - Harborview Med. Ctr., Northwest Family Ctr. Not yet recruiting
Seattle, Washington, United States, 98104-2499
Contact: Corry Venema-Weiss, ARNP    206-884-7869    corry.venemaweiss@seattlechildrens.org   
Argentina
Hosp. General de Agudos Buenos Aires Argentina NICHD CRS Recruiting
Ciudad de Buenos Aires, Buenos Aires, Argentina, C1221ADC
Contact: Silvina Ivalo, MD    54-11-49315252    sivalo@hivramos.org.ar   
Botswana
Molepolole CRS Recruiting
Gaborone, Botswana
Contact: Ayotunde Omoz-Oarhe, MDCM    267-3910388    aomozooarhe@bhp.org.bw   
Gaborone CRS Recruiting
Gaborone, Botswana
Contact: Tebogo Kakhu    267-3931353    tkakhu@bhp.org.bw   
Brazil
SOM Federal University Minas Gerais Brazil NICHD CRS Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30.130-100
Contact: Flavia G. Ferreira, M.D., D.Sc.    55-31-34099111    flaviafaleiro@medicina.ufmg.br   
Hosp. Santa Casa Porto Alegre Brazil NICHD CRS Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
Contact: Debora F. Coelho    55-51-32148008    deby.nh@terra.com.br   
Hospital Nossa Senhora da Conceicao CRS Withdrawn
Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
Hosp. Geral De Nova Igaucu Brazil NICHD CRS Recruiting
Rio de Janeiro, Brazil, 26030
Contact: Gisely G. Falco    55-21-26676059    gisely.falco@gmail.com   
Hosp. dos Servidores Rio de Janeiro NICHD CRS Recruiting
Rio de Janeiro, Brazil, 20221-903
Contact: Leon C. Sidi, MD    55-21-22330018    leon@diphse.com.br   
Univ. of Sao Paulo Brazil NICHD CRS Recruiting
Sao Paulo, Brazil, 14049-900
Contact: Adriana A. Barbaro    55-1632345516    a.tiraboschi@uol.com.br   
Puerto Rico
San Juan City Hosp. PR NICHD CRS Recruiting
San Juan, Puerto Rico, 00936
Contact: Lizbeth Fábregas-Troche, B.S., M.S.    787-764-3083    lfabregas@sanjuanciudadpatria.com   
University of Puerto Rico Pediatric HIV/AIDS Research Program CRS Recruiting
San Juan, Puerto Rico, 00935
Contact: Ruth Santos, BSN, RN, MPH    787-759-9595    ruth.santos@upr.edu   
South Africa
Family Clinical Research Unit (FAM-CRU) CRS Recruiting
Tygerberg, Western Cape Province, South Africa, 7505
Contact: Joan Coetzee    27-21-9384157    joan@sun.ac.za   
Thailand
Siriraj Hospital Mahidol University CRS Not yet recruiting
Bangkok, Bangkoknoi, Thailand, 10700
Contact: Sirintip Sricharoenchai, MD    66-2-8660944    sirintipsri@gmail.com   
Siriraj Hospital ,Mahidol University NICHD CRS Recruiting
Bangkok, Bangkoknoi, Thailand, 10700
Contact: Watcharee Lermankul    66-2-419 7000 ext 5695    watchareeped@gmail.com   
Bhumibol Adulyadej Hosp. CRS Recruiting
Saimai, Bangkok, Thailand, 10220
Contact: Sommai Trathong    66-2-5347000    trathong.sommai@gmail.com   
Phayao Provincial Hosp. CRS Recruiting
T.Tom, Muang, Phayao, Thailand, 56000
Contact: Kunlaya Jansook    66-5-4409300    jkunlaya@gmail.com   
Prapokklao Hosp. CRS Recruiting
Chantaburi, Thailand, 22000
Contact: Ubon Chanasit    66-3-9324975    ubolchan@gmail.com   
Chiang Mai University Pediatrics-Obstetrics CRS Completed
Chiang Mai, Thailand, 50200
Institut de Recherche pour Developpement (IRD) - PHPT CRS Not yet recruiting
Chiang Mai, Thailand, 50100
Chiangrai Prachanukroh Hospital NICHD CRS Recruiting
Chiang Mai, Thailand, 50100
Contact: Pra-ornsuda Sukrakanchana    66-81-746 8858    Pra-ornsuda.Sukrakanchana@phpt.org   
Chiangrai Prachanukroh Hospital CRS Not yet recruiting
Chiangrai, Thailand, 57000
Contact: Supaporn Utsaha    66-53-753114    nhong2513@hotmail.com   
Chonburi Hosp. CRS Recruiting
Chonburi, Thailand, 20000
Contact: Ladda Argadamnuy    66-38-931000    ladda.argad@gmail.com   
Uganda
MU-JHU Research Collaboration CRS Recruiting
Kampala, Mpigi, Uganda
Contact: Carolyne Onyango, MB ChB, M.S.    256-414-541044    carolonyango@mujhu.org   
Sponsors and Collaborators
Investigators
Study Chair: Mark Mirochnick, MD Boston Medical Center
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00042289     History of Changes
Other Study ID Numbers: P1026s, 10040, IMPAACT P1026s, IMPAACT P1025
Study First Received: July 26, 2002
Last Updated: October 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Pregnancy
Pharmacokinetics
Treatment Experienced

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Contraceptive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014