HIVNCT04518228
Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum
An observational study of HIV and Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 23 sites in 8 countries.
Trial summary
The purpose of this study was to evaluate the pharmacokinetic (PK) properties of antiretroviral (ARV) and anti-tuberculosis (TB) drugs administered during pregnancy and postpartum. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV, Tuberculosis
- What is being tested?
- Bictegravir (BIC), Tenofovir alafenamide (TAF) and Long-acting injectable formulation of cabotegravir (CAB LA)
- Type of treatment
- Injection or infusion
- How many people
- 205 participants
- Where
- 23 sitesin 8 countries
- Study dates
- 1 Sep 2021to 10 Jul 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant and postpartum women living with and without HIV (WLHIV and HIV-uninfected women) receiving ARV and/or TB drugs under study, and their infants.
Who may be able to join
- Component 1: Pregnant WLHIV receiving oral ARVs and no TB drugs, and their infants
- 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
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- 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.
- Component 4 Inclusion Criteria: Pregnant WLHIV and HIV-uninfected women receiving second-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 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.
- Components 1-4 Exclusion Criteria:
- At study entry, mother has received within the past 14 days medicines known to interfere with absorption, metabolism, or clearance of the drug or drug combination under study (see study protocol) based on maternal report and available medical records.
- 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.
- Component 5 Exclusion Criteria
- 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.
Who cannot join
None listed.
Trial locations and contacts
23 sites in 8 countries.
23 sites in 8 countries
United States13 sites
Emory University School of Medicine NICHD CRS
Atlanta, Georgia, 30322
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, 80045
Johns Hopkins Univ. Baltimore NICHD CRS
Baltimore, Maryland, 21287
Rush University Cook County Hospital Chicago NICHD CRS
Chicago, Illinois, 60612
Lurie Children's Hospital of Chicago (LCH) CRS (Site ID: 4001)
Chicago, Illinois, 60614
South Florida CDTC Ft Lauderdale NICHD CRS
Fort Lauderdale, Florida, 33316
University of Florida Jacksonville NICHD CRS
Jacksonville, Florida, 32209
Usc La Nichd Crs
Los Angeles, California, 90033
David Geffen School of Medicine at UCLA NICHD CRS
Los Angeles, California, 90095-1752
Pediatric Perinatal HIV NICHD CRS
Miami, Florida, 33136
University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program
San Diego, California, 92103
Bronx-Lebanon Hospital Center NICHD CRS
The Bronx, New York, 10457
Jacobi Med. Ctr. Bronx NICHD CRS
The Bronx, New York, 10461
South Africa3 sites
Desmond Tutu TB Centre - Stellenbosch University (DTTC-SU) CRS
Cape Town, 7505
Wits RHI Shandukani Research
Johannesburg, Gauteng, 2001
Famcru Crs
Tygerberg Hills, 7505
Brazil2 sites
Hospital Federal dos Servidores do Estado NICHD CRS
Rio de Janeiro, 20221-903
Hosp. Geral De Nova Igaucu Brazil NICHD CRS
Rio de Janeiro, 26030
India1 site
Byramjee Jeejeebhoy Medical College (BJMC) CRS
Pune, Maharashtra, 411001
Kenya1 site
Kenya Medical Research Institute / Walter Reed Project Clinical Research Center, Kericho CRS
Kericho, 20200
Puerto Rico1 site
IMPAACT/ Gamma Project/ UPR Pediatric HIV/AIDS Research CRS
San Juan, 00935
Thailand1 site
Siriraj Hospital, Mahidol University NICHD CRS
Bangkok, Bangkoknoi, 10700
About this study
The purpose of this study was to evaluate the pharmacokinetic (PK) properties of antiretroviral (ARV) and anti-tuberculosis (TB) drugs administered during pregnancy and postpartum.
Read the detailed description
This study evaluated the pharmacokinetic (PK) properties of antiretroviral (ARV) and anti-tuberculosis (TB) drugs administered during pregnancy and postpartum.
IMPAACT 2026 was a Phase IV observational clinical study. Participants were not assigned to the drugs under study, but were already receiving the drugs for clinical care as prescribed by their clinical care providers. They were enrolled into study arms according to the drugs they were receiving through clinical care, and if on multiple drugs of interest, were able to enroll into multiple arms simultaneously. No ARVs or TB treatment drugs were supplied as part of this study. All drugs under study were 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 decided to prescribe a higher dose than the approved dose if the PK results for the approved dose indicated that drug exposure may be inadequate.
This study was 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 was to open to accrual independently and accrue independently over approximately 36 months from the first enrollment in each arm. Participants signed a single informed consent for the Component to which they enrolled, and they could only enroll into one component. Women receiving more than one drug under study in a single Component (and their infants) were automatically enrolled into all relevant open arms within that component, based on the drugs under study they were receiving at study entry. There were no changes in arm during the study; a study inclusion criterion was that participants expected to remain on the same treatment regimen until study completion.
Participants in Component 1 were followed up to 12 weeks after delivery for mothers and up to 24 weeks after birth for infants. Participants in Component 2 were to be followed up to 5 weeks after delivery for mothers and infants. Participants in Components 3, 4, and 5 were 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.
Component 2 (Arm 2.1) never opened for enrollment because investigations of the PK and safety of long-acting injectable cabotegravir in pregnancy were to be conducted in a separate study.
Arms 1.1 and 1.4 reached their enrollment targets and were closed to accrual. Arms 1.3 and 5.1 were closed to accrual per the decision of the Core Protocol Team because enrollment had slowed substantially and enough participants had been enrolled to proceed with data analysis and publication.
Arms 1.5, 3.2,3.3, 5.2, and 5.3 did not enroll any participants and were closed to accrual per the decision of the Core Protocol Team, because enrollment of enough participants to result in a publication was not anticipated.
The study was closed to accrual on March 5, 2025 at the recommendation of the IMPAACT Study Monitoring Committee (SMC). Prior to closure, 3 arms had open to accrual status: Arms 1.2, 3.1, and 4.1. The SMC suggested that the study objectives for Arm 3.1 could be achieved with the sample size at the time of closure and that the study objectives for Arms 1.2 and 4.1 could not be met within a reasonable timeframe.
- Conditions
- HIV, Tuberculosis
- Being tested
- Bictegravir (BIC), Tenofovir alafenamide (TAF), Long-acting injectable formulation of cabotegravir (CAB LA), Dolutegravir (DTG), Atazanavir/ritonavir (ATV/r)
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bictegravir (BIC)Drug
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)Drug
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
Long-acting injectable formulation of cabotegravir (CAB LA)Drug
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)Drug
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)Drug
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)Drug
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)Drug
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
CobicistatDrug
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
RitonavirDrug
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 TreatmentDrug
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 TreatmentDrug
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)Drug
Administered consistent with the package inserts and/or instructions provided by the non-study sources who prescribe or supply the drugs to participants
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Bictegravir (BIC) | |
| 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 Receives: Drug: Doravirine (DOR) | |
| Component 1: Arm 1.3: Tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat | Women ≥ 20 weeks gestation not receiving TB drugs and receiving tenofovir alafenamide (TAF) 10 mg q.d. boosted with cobicistat, and their infants Receives: Drug: Tenofovir alafenamide (TAF); Drug: Cobicistat | |
| 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 Receives: Drug: Tenofovir alafenamide (TAF) | |
| 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 Receives: Drug: Tenofovir alafenamide (TAF); Drug: Cobicistat; Drug: Ritonavir | |
| Component 2: Arm 2.1: Long-acting injectable formulation of cabotegravir (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 Receives: Drug: Long-acting injectable formulation of cabotegravir (CAB LA) | |
| 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 Receives: Drug: Dolutegravir (DTG); Drug: First-Line TB Treatment | |
| 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 Receives: Drug: Atazanavir/ritonavir (ATV/r); Drug: Darunavir/ritonavir (DRV/r); Drug: First-Line TB Treatment | |
| 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 Receives: Drug: Lopinavir/ritonavir (LPV/r); Drug: First-Line TB Treatment | |
| 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 Receives: Drug: Second-Line TB Treatment | |
| Component 5: Arm 5.1: ATV/r | Women post-delivery receiving ATV/r, and their infants Receives: Drug: Atazanavir/ritonavir (ATV/r) | |
| Component 5: Arm 5.2: DRV/r | Women post-delivery receiving DRV/r, and their infants Receives: Drug: Darunavir/ritonavir (DRV/r) | |
| Component 5: Arm 5.3: LPV/r | Women post-delivery receiving LPV/r, and their infants Receives: Drug: Lopinavir/ritonavir (LPV/r) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Women Who Meet Area Under the Curve (AUC) Target in Plasma (Component 1)
A target AUC was derived for each drug as the 10th percentile for the non-pregnant population based on historical control data. The target AUC is 58.7 mg*h/L for Arm 1.1 and 10.0 mg*h/L for Arm 1.2. Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods. McNemar's test was not conducted for Arm 1.2 due to low sample size.
Measured: Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 6-12 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, 12, and 24 hours post-dose.
Median Maternal AUC in Plasma (Component 1)
Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods. Wilcoxon signed-rank test was not conducted for Arm 1.2 due to low sample size.
Measured: Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 6-12 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, 12, and 24 hours post-dose.
Median Maternal Tenofovir-diphosphate (TFV-DP) Concentrations in Dried Blood Spots (DBS) (Component 1)
TFV-DP intracellular concentrations in DBS samples. Concentrations obtained from two 7 mm punches.
Measured: Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 6-12 weeks after delivery). Samples collected pre-dose.
Median Maternal Tenofovir-diphosphate (TFV-DP) Concentrations in Peripheral Blood Mononuclear Cells (PBMCs ) (Component 1)
TFV-DP intracellular concentrations in PBMC samples.
Measured: Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 6-12 weeks after delivery). Samples collected pre-dose and at 3 and 24 hours post-dose.
Median Maternal Isoniazid (INH) AUC in Plasma (Component 3)
Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods. AUC reported is the AUC to the last measurable timepoint.
Measured: Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
Median Maternal Rifampin (RIF) AUC in Plasma (Component 3)
Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods. AUC reported is the AUC to the last measurable timepoint.
Measured: Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
Median Maternal Ethambutol (EMB) AUC in Plasma (Component 3)
Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods. AUC reported is the AUC to the last measurable timepoint.
Measured: Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
Median Maternal Pyrazinamide (PZA) AUC in Plasma (Component 3)
Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods. AUC reported is the AUC to the last measurable timepoint. Comparison of Antepartum vs. Postpartum was not done due to low sample size.
Measured: Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
Median Maternal Dolutegravir (DTG) AUC in Plasma (Component 3)
Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods. AUC reported is the AUC to the last measurable timepoint. The data of the P1026s arm was not reported since it's not one of the arms in this study.
Measured: Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
Median Maternal Bedqauiline (BDQ) AUC in Plasma (Component 4)
Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods. AUC reported is the AUC to the last measurable timepoint. Wilcoxon signed-rank test was not conducted for Arm 4.1 due to low sample size.
Measured: Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
Median Maternal Clofazimine (CFZ) AUC in Plasma (Component 4)
Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods. AUC reported is the AUC to the last measurable timepoint. Wilcoxon signed-rank test was not conducted for Arm 4.1 due to low sample size.
Measured: Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
Median Maternal Delamanid (DLM) AUC in Plasma (Component 4)
Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods. AUC reported is the AUC to the last measurable timepoint. Wilcoxon signed-rank test was not conducted for Arm 4.1 due to low sample size.
Measured: Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
Median Maternal Levofloxacin (LFX) AUC in Plasma (Component 4)
Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods. AUC reported is the AUC to the last measurable timepoint.
Measured: Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
Median Maternal Linezolid (LZD) AUC in Plasma (Component 4)
Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods. AUC reported is the AUC to the last measurable timepoint. Wilcoxon signed-rank test was not conducted for Arm 4.1 due to low sample size.
Measured: Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
Median Maternal Atazanavir (ATV) Breast Milk/Maternal Plasma Concentration Ratio (Component 5)
Breast milk and maternal plasma concentrations were collected at study visits and compared as a ratio. A higher ratio indicates the potential for higher infant drug exposure through breast milk. Only measured for mothers who met the breast milk transfer PK sampling requirements outlined in the protocol.
Measured: Measured at 5-9 days, 2-12 weeks, and 16-24 weeks post-delivery
Median Maternal Ritonavir (RTV) Breast Milk/Maternal Plasma Concentration Ratio (Component 5)
Breast milk and maternal plasma concentrations were collected at study visits and compared as a ratio. A higher ratio indicates the potential for higher infant drug exposure through breast milk. Only measured for mothers who met the breast milk transfer PK sampling requirements outlined in the protocol.
Measured: Measured at 5-9 days, 2-12 weeks, and 16-24 weeks post-delivery
Infant Atazanvir (ATV) Plasma Concentration (Component 5)
Only measured for infants who met the breast milk transfer PK sampling requirements outlined in the protocol. The lower limit of quantitation (LLoQ) was 23.4 ng/mL for ATV.
Measured: Measured at 5-9 days, 2-12 weeks, and 16-24 weeks of life
Infant Ritonavir (RTV) Plasma Concentration (Component 5)
Only measured for infants who met the breast milk transfer PK sampling requirements outlined in the protocol. The lower limit of quantitation (LLoQ) was 9.8 ng/mL for RTV.
Measured: Measured at 5-9 days, 2-12 weeks, and 16-24 weeks of life
Secondary outcomes (33)
Median Ratio of Cord Blood Concentration to Maternal Blood Concentration (Component 1, Arms 1.1 and 1.2)
Cord blood and maternal blood concentrations were collected and measured for the drug(s) under study at delivery and compared as a ratio.
Measured: Measured at time of delivery with single cord blood and single maternal blood sample.
Median Ratio of Cord Blood Concentration to Maternal Blood Concentration (Component 1, Arms 1.3 and 1.4)
Cord blood and maternal blood concentrations were collected and measured for the drug(s) under study at delivery and compared as a ratio. There are four analytes for Arms 1.3 and 1.4: tenofovir alafenamide fumarate (TAF) in plasma, tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS), TFV-DP in peripheral blood mononuclear cells (PBMCs), and tenofovir (TFV) in plasma. For Arm 1.3 TAF in plasma, all values were below the lower level of quantitation.
Measured: Measured at time of delivery with single cord blood and single maternal blood sample.
Median Ratio of Cord Blood Concentration to Maternal Blood Concentration (Component 3)
Cord blood and maternal blood concentrations were collected and measured for the drugs under study at delivery and compared as a ratio. The analytes for Arm 3.1 were: isoniazid (INH), rifampin (RIF), ethambutol (EMB), pyrazinamide (PZA), and dolutegravir (DTG).
Measured: Measured at time of delivery with single cord blood and single maternal blood sample.
Median Ratio of Cord Blood Concentration to Maternal Blood Concentration (Component 4)
Cord blood and maternal blood concentrations were collected and measured for the drugs under study at delivery and compared as a ratio. The analytes for Arm 4.1 were: bedaquiline (BDQ), clofazimine (CFZ), delamanid (DLM), levofloxacin (LFX), and linezolid (LZD).
Measured: Measured at time of delivery with single cord blood and single maternal blood sample.
Median Infant Washout Half-life of Drug After Birth (Component 1)
Infant washout PK concentrations were measured during the first 9 days of life. Half-life was calculated based on the concentrations. The analyte of Arm 1.4 is tenofovir in plasma.
Measured: Measured at birth (2-10 hours, 18-28 hours and 36-72 hours) and 5-9 days after birth
Infant Washout Half-life of Drug After Birth (Component 3)
Infant washout PK concentrations were measured during the first 9 days of life. Half-life was calculated based on the concentrations. The analytes for Arm 3.1 were: isoniazid (INH), rifampin (RIF), ethambutol (EMB), pyrazinamide (PZA), and dolutegravir (DTG).
Measured: Measured at birth (2-10 hours, 18-28 hours and 36-72 hours) and 5-9 days after birth
Infant Washout Half-life of Drug After Birth (Component 4)
Infant washout PK concentrations were measured during the first 9 days of life. Half-life was calculated based on the concentrations where it was possible to calculate. The analytes for Arm 4.1 were: bedaquiline (BDQ), clofazimine (CFZ), delamanid (DLM), levofloxacin (LFX), and linezolid (LZD).
Measured: Measured at birth (2-10 hours, 18-28 hours and 36-72 hours) and 5-9 days after birth
Maternal Breast Milk/Maternal Plasma Concentration Ratio (Components 3 and 4)
Breast milk and maternal plasma concentrations were collected at study visits to be compared as a ratio, measured for mothers who met the breast milk transfer PK sampling requirements outlined in the protocol. A higher ratio indicates the potential for higher infant drug exposure through breast milk. Per the protocol, breast milk transfer sampling was not to be performed for Arm 3.1. For Arm 4.1, samples were collected but not run and have yet to be analyzed. The anticipated reporting date is April 2027.
Measured: Measured at 2-8 weeks postpartum (and 5-9 days and 16-24 weeks post-delivery if the requirements for breast milk transfer PK sampling are met)
Infant Plasma Concentration (Component 3)
Plasma concentrations as part of breast milk transfer sampling. Per the protocol, breast milk transfer sampling was not to be performed for Arm 3.1.
Measured: Measured through Week 24
Median Infant Bedaquiline (BDQ) Plasma Concentration (Component 4)
Infant plasma concentration as part of breast milk transfer sampling to describe the kinetics of drug transfer from mother to infant via breast milk
Measured: Measured at 5-9 days, 2-8 weeks, and 16-24 weeks after delivery.
Median Infant Clofazimine (CFZ) Plasma Concentration (Component 4)
Infant plasma concentration as part of breast milk transfer sampling to describe the kinetics of drug transfer from mother to infant via breast milk
Measured: Measured at 5-9 days, 2-8 weeks, and 16-24 weeks after delivery.
Median Infant Delamanid (DLM) Plasma Concentration (Component 4)
Infant plasma concentration as part of breast milk transfer sampling to describe the kinetics of drug transfer from mother to infant via breast milk
Measured: Measured at 5-9 days, 2-8 weeks, and 16-24 weeks after delivery.
Median Infant Levofloxacin (LFX) Plasma Concentration (Component 4)
Infant plasma concentration as part of breast milk transfer sampling to describe the kinetics of drug transfer from mother to infant via breast milk
Measured: Measured at 5-9 days, 2-8 weeks, and 16-24 weeks after delivery.
Median Infant Linezolid (LZD) Plasma Concentration (Component 4)
Infant plasma concentration as part of breast milk transfer sampling to describe the kinetics of drug transfer from mother to infant via breast milk
Measured: Measured at 5-9 days, 2-8 weeks, and 16-24 weeks after delivery.
Median Infant Dolutegravir (DTG) Plasma Concentration (Component 4)
Infant plasma concentration as part of breast milk transfer sampling to describe the kinetics of drug transfer from mother to infant via breast milk
Measured: Measured at 5-9 days, 2-8 weeks, and 16-24 weeks after delivery.
Median Maternal Efavirenz (EFV) AUC in Plasma (Component 4)
Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods.
Measured: Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery).
Median Maternal Lopinavir (LPV) AUC in Plasma (Component 4)
Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods.
Measured: Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery).
Median Median Atazanavir (ATV) AUC in Plasma (Component 4)
Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods.
Measured: Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery).
Median Maternal Darunavir (DRV) AUC in Plasma (Component 4)
Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods.
Measured: Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery).
Median Maternal Dolutegravir (DTG) AUC in Plasma (Component 4)
Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods. AUC reported is the AUC to the last measurable timepoint.
Measured: Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery). Sampling performed pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.
Median Maternal Raltegravir (RAL) AUC in Plasma (Component 4)
Pharmacokinetic parameters were determined by the study pharmacologists from plasma concentration-time profiles using noncompartmental methods.
Measured: Measured at 2nd trimester (2T, 20 0/7 - 26 6/7 weeks of pregnancy), 3rd trimester (3T, 30 0/7 - 37 6/7 weeks of pregnancy), and postpartum (PP, 2-8 weeks after delivery).
Number of Participants With Grade 3 or Higher Maternal Adverse Events
Maternal Grade 3 or higher adverse events. Adverse events were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017.
Measured: Component 1 measured through Week 12 post-delivery; Component 3 and 4 measured through Week 8 post-delivery (except breastmilk transfer women measured through Week 24 post-delivery); Component 5 measured through Week 24 post-delivery.
Number of Participants With Grade 2 or Higher Infant Adverse Events
Infant Grade 2 or higher adverse events. Adverse events were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017.
Measured: Measured from entry through Week 24
Number of Participants With Maternal Serious Adverse Events
Maternal serious adverse events which were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017
Measured: Component 1 measured through Week 12 post-delivery; Component 3 and 4 measured through Week 8 post-delivery (except breastmilk transfer women measured through Week 24 post-delivery); Component 5 measured through Week 24 post-delivery.
Number of Participants With Infant Serious Adverse Events
Infant serious adverse events. Adverse events were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017
Measured: Measured from entry through Week 24
Number of Participants With Grade 3 or Higher Maternal Adverse Events Assessed as Related to the Drug Under Study
Maternal Grade 3 or higher adverse events assessed as related to the drug under study. Adverse events were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017.
Measured: Component 1 measured through Week 12 post-delivery; Component 3 and 4 measured through Week 8 post-delivery (except breastmilk transfer women measured through Week 24 post-delivery); Component 5 measured through Week 24 post-delivery.
Number of Participants With Grade 2 or Higher Infant Adverse Events Assessed as Related to the Drug Under Study
Infant Grade 2 or higher adverse events assessed as related to the drug under study. Adverse events were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017
Measured: Measured from entry through Week 24
Pregnancy Outcome
Outcome of pregnancy categorized as live birth, stillbirth, spontaneous abortion, and etc.
Measured: Measured on maternal delivery date/infant Day 0
Median Gestational Age at Birth
Infant gestational age at birth (weeks)
Measured: Measured on Day 0 (0-3 days)
Median Infant Birth Weight
Infant birth weight (grams)
Measured: Measured on Day 0 (0-3 days)
Occurrence of Congenital Anomaly or Mitochondrial Disorder
Presence of any congenital anomaly or mitochondrial disorder identified in infants.
Measured: Measured from Day 0 through Week 24 for Components 1, 3, 4 and 5; measured from Day 0 through Week 5 for Component 2
Infant HIV Status
Infant HIV status which is determined according to diagnosis per local standard of care
Measured: Measured from Day 0 through Week 24
Maternal HIV-1 RNA
Plasma HIV-1 RNA levels in the mothers as in categories. The highest value of the lower limits of quantitation (LLoQ) for each arm was used for categorizations. The LLoQs are: Arm 1.1 - 40 copies/mL, Arm 1.2 - 20 copies/mL, Arm 1.3 and Arm 1.4 - 200 copies/mL, Arm 3.1 - 40 copies/mL, and Arm 4.1 - 50 copies/mL.
Measured: Measured in 2nd Trimester,(2T, 20 0/7 to 26 6/7 weeks of pregnancy), 3rd Trimester (3T, 30 0/7 to 37 6/7 weeks of pregnancy), delivery, and PP (2-8 weeks or 6-12 weeks after delivery, depending on study arm)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start1 Sep 2021
- Primary completion24 Apr 2025
- Study completion10 Jul 2025
Why it stopped: The study was closed to accrual early based on Study Monitoring Committee review indicating that the study objectives had either been achieved or could not be met within a reasonable timeframe for the then-open arms.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH), Gilead Sciences, ViiV Healthcare, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Mark Mirochnick, MD, Study chair, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518228
- Sponsor's protocol ID
- IMPAACT 2026
- Other IDs
- 38609
- Status last verified
- Aug 2026
- First submitted
- 5 Mar 2020
- Last updated
- 26 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie results in the publication, after deidentification.
Publications
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.
PubMed 39813286