Clinical Trials

MainTitle

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

This study is ongoing, but not recruiting participants.
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier
NCT00042289

First received: July 26, 2002
Last updated: March 30, 2020
Last Verified: March 2020
History of Changes
Purpose

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 : atazanavir/cobicistat
Drug : darunavir/ritonavir
Drug : darunavir/cobicistat
Drug : etravirine
Drug : elvitegravir/cobicistat
Drug : dolutegravir
Drug : tenofovir alafenamide fumarate (TAF)
Drug : TAF/cobicistat
Drug : TAF/ritonavir
Drug : efavirenz
Drug : lopinavir/ritonavir
Drug : nevirapine
Drug : rifampicin
Drug : ethambutol
Drug : isoniazid
Drug : pyrazinamide
Drug : rifampicin
Drug : kanamycin
Drug : amikacin
Drug : capreomycin
Drug : moxifloxacin
Drug : levofloxacin
Drug : ofloxacin
Drug : ethionamide/prothionamide
Drug : terizidone/cycloserine
Drug : para-aminosalicylic acid (PAS)
Drug : high dose isoniazid (INH)
Drug : bedaquiline
Drug : clofazamine
Drug : delamanid
Drug : linezolid
Drug : pretomanid
Drug : atazanavir/ritonavir/tenofovir
Drug : ethinyl estradiol oral contraceptive
Drug : etonogestrel implant
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum

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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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. ]
Secondary Outcome Measures:
  • Ratio of cord blood concentration to maternal blood concentration [ Time Frame: Measured at time of delivery ]
  • Ratio of unbound/total drug concentrations [ Time Frame: Measured at time of delivery ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
  • Infant neurological events of grade 1 or higher [ Time Frame: Measured through 24 weeks of life ]
  • Adverse pregnancy outcome: preterm birth [ Time Frame: Measured through delivery ]
  • Adverse pregnancy outcome: low birth weight [ Time Frame: Measured at delivery ]
  • Adverse pregnancy outcome: fetal demise [ Time Frame: Measured through 24 weeks postpartum ]
  • Adverse pregnancy outcome: congenital anomalies [ Time Frame: Measured through 24 weeks of life ]
  • Infant HIV infection status [ Time Frame: Measured through 24 weeks of life ]

Estimated Enrollment: 1786
Study Start Date: March 2003
Estimated Study Completion Date: September 30, 2020
Estimated Primary Completion Date: September 30, 2020 (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: atazanavir/cobicistat, darunavir/ritonavir, darunavir/cobicistat, etravirine, elvitegravir/cobicistat, dolutegravir, tenofovir alafenamide fumarate (TAF), TAF/cobicistat, TAF/ritonavir, efavirenz, or lopinavir/ritonavir. Note: As of February 2016, the study will no longer enroll women receiving etravirine or increased dose lopinavir/ritonavir.
Drug: atazanavir/cobicistat

Women will receive atazanavir/cobicistat as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: darunavir/ritonavir

Women will receive darunavir/ritonavir as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: darunavir/cobicistat

Women will receive darunavir/cobicistat as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: etravirine

Women will receive etravirine as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: elvitegravir/cobicistat

Women will receive elvitegravir/cobicistat as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: dolutegravir

Women will receive dolutegravir as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: tenofovir alafenamide fumarate (TAF)

Women will receive TAF as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: TAF/cobicistat

Women will receive TAF/cobicistat as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: TAF/ritonavir

Women will receive TAF/ritonavir as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: efavirenz

Women will receive efavirenz as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: lopinavir/ritonavir

Women will receive lopinavir/ritonavir as prescribed by their clinicians. (Dosage will vary for each participant.)

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 TB treatment with at least one of the following TB drugs at study entry: rifampicin, ethambutol, isoniazid, or pyrazinamide. Note: As of February 2016, the study will no longer enroll women receiving nevirapine.
Drug: efavirenz

Women will receive efavirenz as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: lopinavir/ritonavir

Women will receive lopinavir/ritonavir as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: nevirapine

Women will receive nevirapine as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: rifampicin

Women will receive rifampicin as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: ethambutol

Women will receive ethambutol as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: isoniazid

Women will receive isoniazid as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: pyrazinamide

Women will receive pyrazinamide as prescribed by their clinicians. (Dosage will vary for each participant.)

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 first-line TB drugs at study entry: ethambutol, isoniazid, pyrazinamide, or rifampicin.
Drug: ethambutol

Women will receive ethambutol as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: isoniazid

Women will receive isoniazid as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: pyrazinamide

Women will receive pyrazinamide as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: rifampicin

Women will receive rifampicin as prescribed by their clinicians. (Dosage will vary for each participant.)

Experimental: Women with/without ARVs w/TB treatment for drug-resistant TB
HIV-infected and HIV-uninfected pregnant women with or without ARVs will be assigned to this arm if receiving at least two of the following second-line TB drugs at study entry: kanamycin, amikacin, capreomycin, moxifloxacin, levofloxacin, ofloxacin, ethionamide/prothionamide, terizidone/cycloserine, para-aminosalicylic acid (PAS), high dose isoniazid (INH), bedaquiline, clofazamine, delamanid, linezolid, or pretomanid.
Drug: kanamycin

Women will receive kanamycin as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: amikacin

Women will receive amikacin as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: capreomycin

Women will receive capreomycin as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: moxifloxacin

Women will receive moxifloxacin as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: levofloxacin

Women will receive levofloxacin as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: ofloxacin

Women will receive ofloxacin as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: ethionamide/prothionamide

Women will receive ethionamide/prothionamide as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: terizidone/cycloserine

Women will receive terizidone/cycloserine as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: para-aminosalicylic acid (PAS)

Women will receive PAS as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: high dose isoniazid (INH)

Women will receive high dose INH as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: bedaquiline

Women will receive bedaquiline as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: clofazamine

Women will receive clofazamine as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: delamanid

Women will receive delamanid as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: linezolid

Women will receive linezolid as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: pretomanid

Women will receive pretomanid as prescribed by their clinicians. (Dosage will vary for each participant.)

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, darunavir/cobicistat, atazanavir/cobicistat, or efavirenz AND starting combined oral contraceptives formulated with ethinyl estradiol; or atazanavir/ritonavir/tenofovir, efavirenz, atazanavir/cobicistat, or darunavir/cobicistat AND starting etonogestrel implant. Note: As of February 2016, the study will no longer enroll women receiving atazanavir/ritonavir/tenofovir or efavirenz AND starting etonogestrel implant.
Drug: atazanavir/cobicistat

Women will receive atazanavir/cobicistat as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: darunavir/cobicistat

Women will receive darunavir/cobicistat as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: efavirenz

Women will receive efavirenz as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: atazanavir/ritonavir/tenofovir

Women will receive atazanavir/ritonavir/tenofovir as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: ethinyl estradiol oral contraceptive

Women will receive ethinyl estradiol oral contraceptive as prescribed by their clinicians. (Dosage will vary for each participant.)

Drug: etonogestrel implant

Women will receive etonogestrel implant as prescribed by their clinicians. (Dosage will vary for each participant.)

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 five main groups of study arms: HIV-infected pregnant women taking ARVs without TB treatment, HIV-infected pregnant women taking ARVs with first-line TB treatment, HIV-uninfected pregnant women taking no ARVs with first-line TB treatment, HIV-infected and HIV-uninfected pregnant women with or without ARVs with second-line TB treatment for drug-resistant TB, and HIV-infected postpartum women taking ARVs and 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 up to 12 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 for 16 to 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/or postpartum, depending on the study arm. Additional study visits may occur depending on the ARV drug regimen prescribed.

Eligibility

Eligibility

Ages Eligible for Study: Child, Adult, Senior  
Sexes Eligible for Study: Female  
Accepts Healthy Volunteers: No  

Criteria

Maternal Inclusion Criteria:

  • Participant must belong to one of the following 5 groups:
    1. HIV-infected pregnant women greater than or equal to 20 weeks gestation NOT on TB treatment receiving one or more of the ARV drugs/drug combinations specified in the protocol
    2. HIV-infected pregnant women greater than or equal to 20 weeks gestation receiving one of the ARV drugs/drug combinations specified in the protocol and TB treatment with at least one of the TB drugs, specified in the protocol, at study entry
    3. HIV-uninfected pregnant women greater than or equal to 20 weeks gestation receiving at least two of the first-line TB drugs, specified in the protocol, at study entry
    4. HIV-infected and HIV-uninfected pregnant women greater than or equal to 20 weeks gestation receiving at least two of the second-line TB drugs, specified in the protocol, at study entry
    5. HIV-infected women 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. HIV-infected postpartum women on hormonal contraceptives must be planning to continue on ARV and contraceptive regimens until final 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. Note: adequate source documentation, including the date of specimen collection, date of testing, test performed, and test result, must be available.
  • Participants enrolling in the 3rd trimester must enroll by 37 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 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.

  • 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

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

Locations

United States, Alabama
UAB Pediatric Infectious Diseases CRS
Birmingham, Alabama, United States, 35233
United States, California
University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program
La Jolla, California, United States, 92093-0672
Miller Children's Hosp. Long Beach CA NICHD CRS
Long Beach, California, United States, 90806
Usc La Nichd Crs
Los Angeles, California, United States, 90089
David Geffen School of Medicine at UCLA NICHD CRS
Los Angeles, California, United States, 90095-1752
Univ. of California San Francisco NICHD CRS
San Francisco, California, United States, 94143
Harbor UCLA Medical Ctr. NICHD CRS
Torrance, California, United States, 90502
United States, Colorado
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Washington Hosp. Ctr. NICHD CRS
Washington, District of Columbia, United States, 20010
United States, Florida
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States, 32209
Pediatric Perinatal HIV Clinical Trials Unit CRS
Miami, Florida, United States, 33136
USF - Tampa NICHD CRS
Tampa, Florida, United States, 33606
United States, Georgia
Emory University School of Medicine NICHD CRS
Atlanta, Georgia, United States, 30322
Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
Augusta, Georgia, United States, 30912
United States, Illinois
Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program
Chicago, Illinois, United States, 60608
Rush Univ. Cook County Hosp. Chicago NICHD CRS
Chicago, Illinois, United States, 60612
Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
Chicago, Illinois, United States, 60612
Lurie Children's Hospital of Chicago (LCH) CRS
Chicago, Illinois, United States, 60614-3393
United States, Louisiana
Tulane Univ. New Orleans NICHD CRS
New Orleans, Louisiana, United States, 70112
United States, Maryland
Univ. of Maryland Baltimore NICHD CRS
Baltimore, Maryland, United States, 21201
Johns Hopkins Univ. Baltimore NICHD CRS
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Children's Hosp. of Boston NICHD CRS
Boston, Massachusetts, United States, 02115
Boston Medical Center Ped. HIV Program NICHD CRS
Boston, Massachusetts, United States, 02118
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, United States, 01199
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, United States, 01605
United States, Michigan
Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, United States, 48201
United States, New Jersey
Rutgers - New Jersey Medical School CRS
Newark, New Jersey, United States, 07103
United States, New York
Bronx-Lebanon Hospital Center NICHD CRS
Bronx, New York, United States, 10457
Jacobi Med. Ctr. Bronx NICHD CRS
Bronx, New York, United States, 10461
Nyu Ny Nichd Crs
New York, New York, United States, 10016
Metropolitan Hosp. NICHD CRS
New York, New York, United States, 10029
Columbia IMPAACT CRS
New York, New York, United States, 10032
SUNY Stony Brook NICHD CRS
Stony Brook, New York, United States, 11794
United States, North Carolina
DUMC Ped. CRS
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Philadelphia IMPAACT Unit CRS
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Regional Med. Ctr. at Memphis
Memphis, Tennessee, United States, 38103
St. Jude Children's Research Hospital CRS
Memphis, Tennessee, United States, 38105-3678
United States, Texas
Texas Children's Hospital CRS
Houston, Texas, United States, 77030-2399
United States, Washington
Seattle Children's Research Institute CRS
Seattle, Washington, United States, 98101
Argentina
Hosp. General de Agudos Buenos Aires Argentina NICHD CRS
Ciudad de Buenos Aires, Buenos Aires, Argentina, C1221ADC
Botswana
Gaborone CRS
Gaborone, South-East District, Botswana
Molepolole CRS
Gaborone, Botswana
Brazil
SOM Federal University Minas Gerais Brazil NICHD CRS
Belo Horizonte, Minas Gerais, Brazil, 30.130-100
Hosp. Santa Casa Porto Alegre Brazil NICHD CRS
Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
Hosp. dos Servidores Rio de Janeiro NICHD CRS
Rio de Janeiro, Brazil, 20221-903
Hospital Federal dos Servidores do Estado NICHD CRS
Rio de Janeiro, Brazil, 20221-903
Instituto de Puericultura e Pediatria Martagao Gesteira - UFRJ NICHD CRS
Rio de Janeiro, Brazil, 21941-612
Hosp. Geral De Nova Igaucu Brazil NICHD CRS
Rio de Janeiro, Brazil, 26030
Univ. of Sao Paulo Brazil NICHD CRS
Sao Paulo, Brazil, 14049-900
Puerto Rico
University of Puerto Rico Pediatric HIV/AIDS Research Program CRS
San Juan, Puerto Rico, 00935
San Juan City Hosp. PR NICHD CRS
San Juan, Puerto Rico, 00936
South Africa
Wits RHI Shandukani Research Centre CRS
Johannesburg, Gauteng, South Africa, 2001
Desmond Tutu TB Centre - Stellenbosch University (DTTC-SU) CRS
Cape Town, Western Cape Province, South Africa, 7505
Famcru Crs
Tygerberg, Western Cape Province, South Africa, 7505
Tanzania
Kilimanjaro Christian Medical Centre (KCMC)
Moshi, Tanzania
Thailand
Siriraj Hospital ,Mahidol University NICHD CRS
Bangkok, Bangkoknoi, Thailand, 10700
Bhumibol Adulyadej Hosp. CRS
Saimai, Bangkok, Thailand, 10220
Phayao Provincial Hosp. CRS
T.Tom, Muang, Phayao, Thailand, 56000
Prapokklao Hosp. CRS
Chantaburi, Thailand, 22000
Chiangrai Prachanukroh Hospital NICHD CRS
Chiang Mai, Thailand, 50100
Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS
Chiang Mai, Thailand, 50200
Chonburi Hosp. CRS
Chonburi, Thailand, 20000
Uganda
MU-JHU Research Collaboration (MUJHU CARE LTD) CRS
Kampala, Uganda

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Study Chair: Mark Mirochnick, MD Boston Medical Center
More Information

More Information


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: March 30, 2020  

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Pregnancy
Pharmacokinetics
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Ritonavir
Lopinavir
Darunavir
Atazanavir Sulfate
Tenofovir
Dolutegravir
Nevirapine
Cobicistat
Moxifloxacin
Efavirenz
Levofloxacin
Ofloxacin
Rifampin
Isoniazid
Linezolid
Cycloserine
Pyrazinamide
Ethambutol
Amikacin
Etravirine
Bedaquiline
Clofazimine
Aminosalicylic Acid
Prothionamide
Kanamycin
Ethionamide
Capreomycin
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Contraceptive Agents
Norgestimate, ethinyl estradiol drug combination
Etonogestrel
Desogestrel
Contraceptives, Oral
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol

ClinicalTrials.gov processed this data on April 08, 2020
This information is provided by ClinicalTrials.gov.