Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum
NCT ID: NCT04518228
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
205 participants
OBSERVATIONAL
2021-09-01
2025-07-10
Brief Summary
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Detailed Description
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IMPAACT 2026 is a Phase IV observational clinical study. Participants are not assigned to the drugs under study, but are already receiving the drugs for clinical care by prescription of their clinical care providers. They are enrolled into study arms according to the drugs they are receiving through clinical care, and if on multiple drugs of interest, are able to enroll into multiple arms simultaneously. No ARVs or TB treatment drugs are supplied as part of this study. All drugs under study are provided by non-study sources. The study sponsor added this observational study to an existing investigational new drug (IND) number for off-label use in case the participant's clinical care provider decides to prescribe a higher dose than the approved dose if the PK results for the approved dose indicate that drug exposure may be inadequate.
This study is comprised of five components which in turn are comprised of arms specific to each drug or drug combination being evaluated:
* Component 1 (Arms 1.1, 1.2. 1.3. 1.4. and 1.5): Pregnant women living with HIV (WLHIV) receiving oral ARVs and no TB drugs, and their infants.
* Component 2 (Arm 2.1): Pregnant WLHIV and HIV-uninfected women who received long-acting/extended release ARVs during pregnancy, and their infants.
* Component 3 (Arms 3.1, 3.2, and 3.3): Pregnant WLHIV receiving ARVs and first-line TB treatment, and their infants.
* Component 4 (Arm 4.1): Pregnant WLHIV and HIV-uninfected women receiving second-line TB treatment, and their infants.
* Component 5 (Arms 5.1, 5.2. and 5.3): Postpartum WLHIV breastfeeding while receiving oral ARVs, and their infants.
Each arm will open to accrual independently and will accrue independently over approximately 36 months from the first enrollment in each arm.
Participants in Component 1 will be followed up to 12 weeks after delivery for mothers and up to 24 weeks after birth for infants. Participants in Component 2 will be followed up to 5 weeks after delivery for mothers and infants. Participants in Components 3, 4, and 5 will be followed up to 24 weeks after delivery for mothers and infants.
Study visits may include:
* Component 1: Maternal clinical and laboratory evaluations and PK sampling at second trimester (2T), third trimester (3T), delivery, and 6-12 weeks post-partum (PP). Infant clinical evaluations and washout PK sampling at birth and 5-9 days after birth.
* Component 2: Maternal clinical and laboratory evaluations and PK sampling at delivery. Infant clinical evaluations and washout PK sampling at birth, 5-9 days, and 12-16 days after birth. Maternal and infant breast milk transfer PK sampling at 5-9 days, 12-16 days, and 3-5 weeks after delivery.
* Component 3: Maternal clinical and laboratory evaluations and PK sampling at second trimester (2T), third trimester (3T), delivery, and 2-8 weeks post-partum (PP). Infant clinical evaluations and washout PK sampling at birth and 5-9 days after birth. Maternal and infant breast milk transfer PK sampling at 5-9 days, 2-8 weeks, and 16-24 weeks after delivery.
* Component 4: Maternal clinical and laboratory evaluations and PK sampling at second trimester (2T), third trimester (3T), delivery, and 2-8 weeks post-partum (PP). Infant clinical evaluations and washout PK sampling at birth and 5-9 days after birth. Maternal and infant breast milk transfer PK sampling at 5-9 days, 2-8 weeks, and 16-24 weeks after delivery.
* Component 5: Maternal and infant clinical evaluations and breast milk transfer PK sampling at 5-9 days, 2-12 weeks, and 16-24 weeks after delivery.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Component 1: Arm 1.1: Bictegravir (BIC) 50 mg q.d.
Women ≥ 20 weeks gestation not receiving TB drugs and receiving bictegravir (BIC) 50 mg once daily (q.d.), and their infants
Bictegravir (BIC)
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Component 1: Arm 1.2: Doravirine (DOR) 100 mg q.d.
Women ≥ 20 weeks gestation not receiving TB drugs and receiving doravirine (DOR) 100 mg q.d., and their infants
Doravirine (DOR)
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Component 1: Arm 1.3: Tenofovir alafenamide (TAF) 10 mg q.d.
Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat, and their infants
Tenofovir alafenamide (TAF)
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Cobicistat
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Component 1: Arm 1.4: TAF 25 mg q.d. without boosting
Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. without boosting, and their infants
Tenofovir alafenamide (TAF)
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Component 1: Arm 1.5: TAF 25 mg q.d. with boosting
Women ≥ 20 weeks gestation not receiving TB drugs and receiving TAF 25 mg q.d. boosted with cobicistat or ritonavir, and their infants
Tenofovir alafenamide (TAF)
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Cobicistat
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Ritonavir
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Component 2: Arm 2.1: CAB LA
Women ≥ 24 weeks gestation who received at least one dose of long-acting injectable formulation of cabotegravir (CAB LA) any dose during pregnancy, and their infants
Cabotegravir (CAB)
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Component 3: Arm 3.1: Dolutegravir (DTG) 50 mg
Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving dolutegravir (DTG) 50 mg twice daily (b.i.d.) when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen, and their infants
Dolutegravir (DTG)
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
First-Line TB Treatment
Participants will be receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), or moxifloxacin (MFX).
Drugs will be administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants.
Component 3: Arm 3.2: ATV/r or DRV/r
Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving atazanavir/ritonavir (ATV/r) ≥ 300/100 mg q.d. or darunavir/ritonavir (DRV/r) ≥ 600/100 mg b.i.d., and their infants
Atazanavir/ritonavir (ATV/r)
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Darunavir/ritonavir (DRV/r)
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
First-Line TB Treatment
Participants will be receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), or moxifloxacin (MFX).
Drugs will be administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants.
Component 3: Arm 3.3: Lopinavir/ritonavir (LPV/r) 800/200 mg
Women ≥ 20 weeks gestation receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), moxifloxacin (MFX), and receiving lopinavir/ritonavir (LPV/r) 800/200 mg b.i.d., and their infants
Lopinavir/ritonavir (LPV/r)
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
First-Line TB Treatment
Participants will be receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), or moxifloxacin (MFX).
Drugs will be administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants.
Component 4: Arm 4.1: Second-line TB treatment drugs
Women ≥ 20 weeks gestation receiving at least one of the following second-line TB treatment drugs, and their infants:
* Levofloxacin (LFX) 750mg - 1000mg q.d.
* Clofazimine (CFZ) 100mg q.d.
* Linezolid (LZD) 300mg - 600mg q.d.
* Bedaquiline (BDQ) 200mg three times per week (t.i.w.)
* Delamanid (DLM) 100mg b.i.d.
* Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study
Second-Line TB Treatment
Participants will be receiving second-line TB treatment with at least one of the following second-line TB treatment drugs:
* Levofloxacin (LFX) 750mg - 1000mg q.d.
* Clofazimine (CFZ) 100mg q.d.
* Linezolid (LZD) 300mg - 600mg q.d.
* Bedaquiline (BDQ) 200mg three times per week (t.i.w.)
* Delamanid (DLM) 100mg b.i.d.
* Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study
Drugs will be administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants.
Component 5: Arm 5.1: ATV/r
Women post-delivery receiving ATV/r, and their infants
Atazanavir/ritonavir (ATV/r)
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Component 5: Arm 5.2: DRV/r
Women post-delivery receiving DRV/r, and their infants
Darunavir/ritonavir (DRV/r)
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Component 5: Arm 5.3: LPV/r
Women post-delivery receiving LPV/r, and their infants
Lopinavir/ritonavir (LPV/r)
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Interventions
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Bictegravir (BIC)
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Tenofovir alafenamide (TAF)
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Cabotegravir (CAB)
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Dolutegravir (DTG)
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Atazanavir/ritonavir (ATV/r)
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Darunavir/ritonavir (DRV/r)
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Lopinavir/ritonavir (LPV/r)
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Cobicistat
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Ritonavir
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
First-Line TB Treatment
Participants will be receiving first-line TB treatment with at least two of the following TB treatment drugs: isoniazid (INH), rifampin (RIF), rifabutin (RFB), ethambutol (EMB), pyrazinamide (PZA), or moxifloxacin (MFX).
Drugs will be administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants.
Second-Line TB Treatment
Participants will be receiving second-line TB treatment with at least one of the following second-line TB treatment drugs:
* Levofloxacin (LFX) 750mg - 1000mg q.d.
* Clofazimine (CFZ) 100mg q.d.
* Linezolid (LZD) 300mg - 600mg q.d.
* Bedaquiline (BDQ) 200mg three times per week (t.i.w.)
* Delamanid (DLM) 100mg b.i.d.
* Moxifloxacin (MFX) 400mg or 800mg q.d., and at least one other second-line TB treatment drug under study
Drugs will be administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants.
Doravirine (DOR)
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Eligibility Criteria
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Inclusion Criteria
* Mother is of legal age or otherwise able to provide independent informed consent as determined by site standard operating procedures (SOPs) and consistent with site institutional review board (IRB)/ethics committee (EC) policies and procedures, and is willing and able to provide written informed consent for her own and her infant's participation in this study.
* Prior to study entry, HIV status confirmed as HIV infected per study protocol.
* At study entry, pregnant and in one of the following two enrollment windows based on best available obstetrical estimate of gestational age:
* Second trimester: gestational age of 20 0/7 to 26 6/7 weeks
* Third trimester: gestational age of 30 0/7 to 37 6/7 weeks
* At study entry, receiving at least one of the following oral ARV drugs or drug combinations, based on maternal report and available medical records:
* Arm 1.1: Bictegravir (BIC) 50 mg q.d.
* Arm 1.2: Doravirine (DOR) 100 mg q.d.
* Arm 1.3: Tenofovir alafenamide (TAF) - 10 mg q.d. boosted with cobicistat
* Arm 1.4: TAF 25 mg q.d. without boosting
* Arm 1.5: TAF 25 mg q.d. boosted with cobicistat or ritonavir
* At study entry, planning to continue the current ARV regimen through at least 12 weeks post-delivery, based on maternal report and available medical records.
* At study entry, has been receiving the drug or drug combination under study at the required dose for at least two weeks, based on maternal report and available medical records.
* At study entry, assessed by study staff as having no identified barriers to completing initial PK sampling within 20 0/7 - 26 6/7 weeks gestation (second trimester) or 30 0/7 to 37 6/7 weeks gestation (third trimester) and within 14 days of enrollment.
* At study entry, if receiving a generic formulation of the drug or drug combination under study, approval of the formulation per study protocol.
* At study entry, not receiving any TB drugs (for either prophylaxis or treatment), based on maternal report and available medical records.
Component 2: Pregnant WLHIV and HIV-uninfected women who received long-acting/extended release ARVs during pregnancy, and their infants
* If of legal age or otherwise able to provide independent informed consent as determined by site SOPs and consistent with site IRB/EC policies and procedures: Willing and able to provide written informed consent for her own and her infant's participation in this study.
* If not of legal age or otherwise unable to provide independent informed consent as determined by site SOPs and consistent with site IRB/EC policies and procedures: Parent/guardian or other legally authorized representative of the mother and her infant is willing and able to provide written informed consent for the mother and her infant's study participation; in addition, when applicable, the mother is willing and able to provide written assent for her own and her infant's study participation.
* At study entry, intends to deliver at the study-affiliated clinic or hospital, based on maternal report.
* At study entry, gestational age of at least 24 0/7 weeks based on best available obstetrical estimate of gestational age, and not yet delivered.
* At study entry, has received at least one administration of the following, based on available medical records, during the current pregnancy:
* Arm 2.1: Long-acting injectable formulation of cabotegravir (CAB LA) (any dose)
Component 3: Pregnant WLHIV receiving ARVs with first-line TB treatment, and their infants
* Mother is of legal age or otherwise able to provide independent informed consent as determined by site SOPs and consistent with site IRB/EC policies and procedures, and is willing and able to provide written informed consent for her own and her infant's participation in this study.
* Prior to study entry, HIV status confirmed as HIV infected per study protocol.
* At study entry, pregnant and in one of the following two enrollment windows, based on best available obstetrical estimate of gestational age:
* Second trimester: gestational age of 20 0/7 to 26 6/7 weeks
* Third trimester: gestational age of 30 0/7 to 37 6/7 weeks
* At study entry, receiving at least two of the following first-line TB treatment drugs under study AND at least one of the following ARV drugs or drug combinations under study, based on maternal report and available medical records:
* First-line TB treatment drugs:
* Isoniazid (INH) 4-6 mg/kg (max 300 mg) q.d.
* Rifampin (RIF) 8-12 mg/kg (max 600 mg) q.d.
* Rifabutin (RFB) 150-300 mg q.d.
* Ethambutol (EMB) 15-20 mg/kg q.d.
* Pyrazinamide (PZA) 20-30 mg/kg q.d.
* Moxifloxacin (MFX) 400 mg or 800mg q.d
* ARVs:
* Arm 3.1: Dolutegravir (DTG) 50 mg b.i.d. when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen
* Arm 3.2: Atazanavir/ritonavir (ATV/r) ≥300/100 mg q.d. or Darunavir/ritonavir (DRV/r) ≥ 600/100 mg b.i.d.
* Arm 3.3: Lopinavir/ritonavir (LPV/r) 800/200 mg b.i.d.
* At study entry, has been receiving the drug combination under study at the required dose for at least two weeks based on maternal report and available medical records.
* At study entry, assessed by study staff as having no identified barriers to completing initial PK sampling within 20 0/7 - 26 6/7 weeks gestation (second trimester) or 30 0/7 to 37 6/7 weeks gestation (third trimester) and within 14 days of enrollment.
* At study entry, if receiving a generic ARV or TB formulation of the drug or drug combination under study, approval of the formulation per study protocol.
* At study entry, planning to continue the current ARV regimen through at least 8 weeks post-delivery, based on maternal report and available medical records.
* Mother is of legal age or otherwise able to provide independent informed consent as determined by site SOPs and consistent with site IRB/EC policies and procedures, and is willing and able to provide written informed consent for her own and her infant's participation in this study.
* Prior to study entry, HIV status confirmed as HIV-infected or HIV-uninfected, per study protocol.
* At study entry, pregnant and in one of the following two enrollment windows based on best available obstetrical estimate of gestational age:
* Second trimester: gestational age of 20 0/7 to 26 6/7 weeks
* Third trimester: gestational age of 30 0/7 to 37 6/7 weeks
* At study entry, receiving at least one of the following second-line TB treatment drugs under study, based on maternal report and available medical records:
* Arm 4.1: Second-line TB treatment drugs:
* Levofloxacin (LFX) 750mg - 1000mg q.d.
* Clofazimine (CFZ) 100mg q.d.
* Linezolid (LZD) 300mg - 600mg q.d.
* Bedaquiline (BDQ) 200mg t.i.w.
* Delamanid (DLM) 100mg b.i.d.
* Moxifloxacin (MFX) 400mg or 800mg q.d and at least one other second-line TB treatment drug under study
* At study entry, has been receiving the drugs under study at the required dose for at least two weeks, based on maternal report and available medical records.
* At study entry, assessed by study staff as having no identified barriers to completing initial PK sampling within 20 0/7 - 26 6/7 weeks gestation (second trimester) or 30 0/7 to 37 6/7 weeks gestation (third trimester) and within 14 days of enrollment.
* At study entry, if receiving a generic formulation of the drug(s) under study, approval of the formulation per study protocol.
Component 5: Postpartum WLHIV breastfeeding while receiving oral ARVs, and their infants
* Mother is of legal age or otherwise able to provide independent informed consent as determined by site SOPs and consistent with site IRB/EC policies and procedures, and is willing and able to provide written informed consent for her own and her infant's participation in this study.
* Prior to study entry, HIV status confirmed as HIV infected, per study protocol.
* At study entry, within 5-9 days post-delivery (inclusive).
* At study entry, breastfeeding mother-infant pair intends to continue exclusive breastfeeding through at least 16 weeks post-delivery.
* At study entry, mother is receiving any of the following oral ARV drugs or drug combinations:
* Arm 5.1: Atazanavir/ritonavir (ATV/r)
* Arm 5.2: Darunavir/ritonavir (DRV/r)
* Arm 5.3: Lopinavir/ritonavir (LPV/r)
* At study entry, mother has been receiving the drug(s) or drug combination(s) under study at the required dose for at least two weeks, based on maternal report and available medical records.
* At study entry, assessed by study staff as having no identified barriers to completing initial PK sampling within the 5-9 days post-delivery PK sampling window.
* At study entry, mother is planning to continue the current ARV regimen through at least 16 weeks post-delivery, based on maternal report and available medical records.
* At study entry, if receiving a generic ARV formulation of the drug or drug combination under study, approval of the formulation per study protocol.
* At study entry, infant weighs at least 1000 grams, based on available medical records.
* At study entry, infant 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.
Exclusion Criteria
* Note: RIF is permitted for mothers in Components 3 and 4 being evaluated for TB and ARV drug interactions.
* At study entry, has a clinical or laboratory finding or condition that, in the opinion of the site investigator, is likely to require a change of the ARV or TB drug under study during the period of study follow-up.
* Arms 1.3, 1.4 and 1.5 only: At study entry, mother has received TDF-based therapy within the past 6 months.
* Mother is currently enrolled in Components 1, 2, 3, or 4.
* At study entry, the mother or infant has received within the past 14 days medicines known to interfere with absorption, metabolism, or clearance of the drug or drug combination under study based on maternal report and available medical records (see study protocol).
* At study entry, mother or infant has a clinical or laboratory finding or condition that, in the opinion of the site investigator, is likely to require a change of the drug under study during study follow-up.
FEMALE
No
Sponsors
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International Maternal Pediatric Adolescent AIDS Clinical Trials Group
NETWORK
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Mental Health (NIMH)
NIH
Gilead Sciences
INDUSTRY
ViiV Healthcare
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Mark Mirochnick, MD
Role: STUDY_CHAIR
Boston University
Locations
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Usc La Nichd Crs
Los Angeles, California, United States
David Geffen School of Medicine at UCLA NICHD CRS
Los Angeles, California, United States
University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program
San Diego, California, United States
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States
South Florida CDTC Ft Lauderdale NICHD CRS
Fort Lauderdale, Florida, United States
University of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States
Pediatric Perinatal HIV NICHD CRS
Miami, Florida, United States
Emory University School of Medicine NICHD CRS
Atlanta, Georgia, United States
Rush University Cook County Hospital Chicago NICHD CRS
Chicago, Illinois, United States
Lurie Children's Hospital of Chicago (LCH) CRS (Site ID: 4001)
Chicago, Illinois, United States
Johns Hopkins Univ. Baltimore NICHD CRS
Baltimore, Maryland, United States
Bronx-Lebanon Hospital Center NICHD CRS
The Bronx, New York, United States
Jacobi Med. Ctr. Bronx NICHD CRS
The Bronx, New York, United States
Hospital Federal dos Servidores do Estado NICHD CRS
Rio de Janeiro, , Brazil
Hosp. Geral De Nova Igaucu Brazil NICHD CRS
Rio de Janeiro, , Brazil
Byramjee Jeejeebhoy Medical College (BJMC) CRS
Pune, Maharashtra, India
Kenya Medical Research Institute / Walter Reed Project Clinical Research Center, Kericho CRS
Kericho, , Kenya
IMPAACT/ Gamma Project/ UPR Pediatric HIV/AIDS Research CRS
San Juan, , Puerto Rico
Wits RHI Shandukani Research
Johannesburg, Gauteng, South Africa
Desmond Tutu TB Centre - Stellenbosch University (DTTC-SU) CRS
Cape Town, , South Africa
Famcru Crs
Tygerberg Hills, , South Africa
Siriraj Hospital, Mahidol University NICHD CRS
Bangkok, Bangkoknoi, Thailand
Baylor-Uganda CRS
Kampala, , Uganda
Countries
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References
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Powis KM, Pinilla M, McMorrow F, Stek A, Brooks KM, Shapiro DE, Knowles K, Eke AC, Greene E, Agwu A, Topete L, Browning R, Chakhtoura N, Arora P, Huang X, Best BM, Mirochnick M, Momper JD; IMPAACT 2026 Protocol Team. Pharmacokinetics and Safety of Bictegravir in Pregnant and Postpartum Persons With HIV and Their Infants. J Acquir Immune Defic Syndr. 2025 Mar 1;98(3):300-307. doi: 10.1097/QAI.0000000000003571.
Other Identifiers
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38609
Identifier Type: REGISTRY
Identifier Source: secondary_id
IMPAACT 2026
Identifier Type: -
Identifier Source: org_study_id