Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
NCT ID: NCT00042289
Last Updated: 2025-12-02
Study Results
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View full resultsBasic Information
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COMPLETED
1578 participants
OBSERVATIONAL
2003-06-09
2020-09-30
Brief Summary
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Detailed Description
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P1026s is a Phase IV clinical study. Participants were not assigned to the drugs under study, but were already receiving the drugs for clinical care by prescription of 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 drugs were provided as part of this study. This observational study was added to an existing investigational new drug (IND) number because several of the drugs were studied at a higher does than the approved dose after the PK results for the approved dose were found to be inadequate.
P1026s went through 10 protocol versions, with the first and last versions of the protocol finalized in 2002 and 2016, respectively. New study arms were added and analyzed separately with each update of the protocol version. In general, there were 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. The primary analysis of each arm was designed and conducted as a separate single arm evaluation of the drug (or combination of drugs) of interest.
Women who were 20 0/7 weeks to 37 6/7 weeks pregnant were enrolled in this study and remained in the study for up to 12 weeks after delivery. Postpartum women were enrolled at 2 to 12 weeks after delivery and followed until 6 to 7 weeks after starting contraceptives. Infants were enrolled in-utero and followed for 16 to 24 weeks of life. At all study visits, participants underwent a medical history, a physical exam, and blood collection. At some visits, women in some arms underwent a vaginal swab. Blood collection from the mother and the detached umbilical cord occurred during delivery. Intensive PK sampling was performed at study visits during the second and third trimester of pregnancy and/or postpartum, depending on the study arm. Additional study visits may have occurred depending on the ARV drug regimen prescribed. Infant washout PK samples were collected at 2-10, 18-28, 36-72 hours after birth, and 5-9 days of life.
There are a total of 49 study arms across all versions of P1026s protocols. Out of the 49 study arms, 2 did not have PK data\* \[didanosine delayed release (DDI) and lopinavir/ritonavir (LPV/RTV) African sites only\]; 2 never enrolled any participants \[amprenavir (APV) and nevirapine/rifampicin (NVP/RIF) with at least one first line TB drug\]; 9 are in the line to be tested/analyzed due to batched analysis which has to be done after the end of the study, the lengthy process of development, validation and approval (regulatory burdens), and laboratory delays related to the COVID-19 pandemic \[all TB arms and all but 3 contraceptive arms (atazanavir/ritonavir/tenofovir (ATV/RTV/TFV) with etonogestrel (ENG), efavirenz (EFV) with ENG, and LPV/RTV with ENG)\]; and 8 had completion dates earlier than December 26, 2007 \[nevirapine (NVP), abacavir (ABC), LPV/RTV 400/100 mg twice daily (b.i.d.), LPV/RTV 400/100mg then 533/133mg b.i.d, nelfinavir (NFV), emtricitabine (FTC), indinavir/ritonavir (IDV/RTV), and tipranavir/ritonavir\]. In this submission, the Results Section presents participant flow, baseline characteristics and adverse events for all study arms (except the 2 arms that never enrolled), and outcome measure results for the 28 remaining study arms that have been completed and have final results available. For study arms completed prior to December 26, 2007, refer to the study publications in the References section for outcome measures.
For arms with very low enrollment (N\<3), some results throughout the record (e.g. baseline characteristics and outcome measures) were not reported in order to avoid making individual participant data identifiable.
In the Outcome Measures section, there could be multiple outcome measures for same PK parameters (e.g. AUC12) depending on different units or summary statistics used in the analyses (such as median with range vs. median with interquartile range (IQR)).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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DRV/RTV 600 or 800 or 900/100mg b.i.d. then 800 or 900/100mg b.i.d. then 600/100mg b.i.d.
HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received:
darunavir/ritonavir (DRV/RTV) 600/100 mg twice daily (b.i.d.) or 800/100 mg b.i.d. until 30 weeks gestation; then 800/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn.
OR darunavir/ritonavir twice daily 600/100 mg b.i.d. or 900/100 mg b.i.d. until 30 weeks gestation; then 900/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn.
darunavir/ritonavir dosage #1
darunavir/ritonavir twice daily 600/100 mg b.i.d.
darunavir/ritonavir dosage #2
darunavir/ritonavir twice daily 800/100 mg b.i.d.
darunavir/ritonavir dosage #3
darunavir/ritonavir twice daily 900/100 mg b.i.d.
DTG 50mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received dolutegravir (DTG) 50 mg once a day (q.d.).
dolutegravir
dolutegravir 50 mg q.d.
TAF 25mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 25 mg q.d. without cobicistat or ritonavir boosting.
tenofovir alafenamide fumarate (TAF)
TAF 25 mg q.d. without cobicistat or ritonavir boosting
TAF 10mg q.d. w/COBI
HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 10 mg q.d. with cobicistat (COBI).
TAF w/cobicistat
TAF 10 mg q.d. with cobicistat
TAF 25mg q.d. w/COBI or RTV boosting
HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 25 mg q.d. with cobicistat (COBI) or ritonavir (RTV) boosting.
TAF w/cobicistat or ritonavir
TAF 25 mg q.d. with cobicistat or ritonavir boosting
EVG/COBI 150/150mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received elvitegravir/cobicistat (EVG/COBI) 150/150 mg q.d
elvitegravir/cobicistat
elvitegravir/cobicistat 150/150 mg q.d.
DRV/COBI 800/150 mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received darunavir/cobicistat (DRV/COBI) 800/150 mg q.d.
darunavir/cobicistat
darunavir/cobicistat 800/150 mg q.d.
ATV/COBI 300/150 mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received atazanavir/cobicistat (ATV/COBI) 300/150 mg q.d.
atazanavir/cobicistat
atazanavir/cobicistat 300/150 mg q.d.
EFV 600 mg q.d. (outside THA)
HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received efavirenz (EFV) 600 mg q.d. (Participants outside of Thailand only)
efavirenz
efavirenz 600 mg q.d.
EFV 600mg q.d. and at least one 1st line TB drug
HIV-infected pregnant women ≥ 20 weeks gestation who received efavirenz (EFV) 600mg q.d.and TB treatment with at least one of the following TB drugs at study entry:
* rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
* ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.
* isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
* pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.
efavirenz
efavirenz 600 mg q.d.
rifampicin
rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
ethambutol
ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.
isoniazid
isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
pyrazinamide
pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.
LPV/RTV 800/200mg b.i.d. and at least one 1st line TB drug
HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (LPV/RTV) 800/200mg b.i.d. and TB treatment with at least one of the following TB drugs at study entry:
* rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
* ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.
* isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
* pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.
lopinavir/ritonavir dosage #1
lopinavir/ritonavir 800/200mg b.i.d.
rifampicin
rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
ethambutol
ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.
isoniazid
isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
pyrazinamide
pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.
No ARVs and at least two 1st line TB drugs
HIV-uninfected pregnant women ≥ 20 weeks gestation who received at least two of the following first line TB drugs at study entry:
* rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
* ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.
* isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
* pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.
rifampicin
rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
ethambutol
ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.
isoniazid
isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
pyrazinamide
pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.
At least two 2nd line TB drugs w/ or w/out ARVs
HIV-infected and HIV-uninfected pregnant women ≥ 20 weeks gestation who received at least two of the following second line TB drugs at study entry:
Injectable agents:
* kanamycin
* amikacin
* capreomycin
Fluoroquinolones:
* moxifloxacin
* levofloxacin
* ofloxacin
Oral bacteriostatic second-line agents:
* ethionamide/prothionamide
* terizidone/cycloserine
* para-aminosalicylic acid (PAS)
Other agents:
* high dose INH
* bedaquiline
* clofazamine
* delamanid
* linezolid
* pretomanid
kanamycin
kanamycin (2nd line TB drug)
amikacin
amikacin (2nd line TB drug)
capreomycin
capreomycin (2nd line TB drug)
moxifloxacin
moxifloxacin (2nd line TB drug)
levoflaxacin
levofloxacin (2nd line TB drug)
ofloxacin
ofloxacin (2nd line TB drug)
ethionamide/prothionamide
ethionamide/prothionamide (2nd line TB drug)
terizidone/cycloserine
terizidone/cycloserine (2nd line TB drug)
para-aminosalicylic acid (PAS)
para-aminosalicylic acid (PAS) (2nd line TB drug)
high dose INH
high dose INH (2nd line TB drug)
bedaquiline
bedaquiline (2nd line TB drug)
clofazamine
clofazamine (2nd TB drug)
delamanid
delamanid (2nd line TB drug)
linezolid
linezolid (2nd line TB drug)
pretomanid
pretomanid (2nd line TB drug)
DRV/COBI 800/150mg q.d. or ATV/COBI 300/150mg q.d with 30-35ug EE
HIV-infected women 2-12 weeks (14-84 days) post-delivery who received darunavir/cobicistat (DRV/COBI) 800/150 mg q.d. or atazanavir/cobicistat (ATV/COBI) 300/150 mg q.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol
atazanavir/cobicistat
atazanavir/cobicistat 300/150 mg q.d.
darunavir/cobicistat
darunavir/cobicistat 800/150 mg q.d.
ethinyl estradiol
oral contraceptives formulated with 30-35 μg ethinyl estradiol
DRV/COBI 800/150mg q.d. or ATV/COBI 300/150mg q.d with ENG
HIV-infected women 2-12 weeks (14-84 days) post-delivery who received darunavir/cobicistat (DRV/COBI) 800/150 mg q.d. or atazanavir/cobicistat (ATV/COBI) 300/150 mg q.d. postpartum and starting etonogestrel (ENG) implant
atazanavir/cobicistat
atazanavir/cobicistat 300/150 mg q.d.
darunavir/cobicistat
darunavir/cobicistat 800/150 mg q.d.
etonogestrel implant
etonogestrel implant contraceptive
EFV 600mg q.d. with 30-35ug EE
HIV-infected women 2-12 weeks (14-84 days) post-delivery who received efavirenz (EFV) 600mg q.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol (EE)
efavirenz
efavirenz 600 mg q.d.
ethinyl estradiol
oral contraceptives formulated with 30-35 μg ethinyl estradiol
ATV/RTV/TFV 300/100/300mg q.d. with 30-35ug EE
HIV-infected women 2-12 weeks (14-84 days) post-delivery who received atazanavir/ritonavir/tenofovir (ATV/RTV/TFV) 300/100/300 mg q.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol (EE)
atazanavir/ritonavir/tenofovir dosage #1
atazanavir/ritonavir/tenofovir 300/100/300mg q.d.
ethinyl estradiol
oral contraceptives formulated with 30-35 μg ethinyl estradiol
NVP 200mg b.i.d
HIV-infected pregnant women ≥ 26 weeks gestation who received nevirapine (NVP) 200 mg twice a day
nevirapine
nevirapine 200 mg twice a day
APV 1200mg b.i.d
HIV-infected pregnant women ≥ 26 weeks gestation who received amprenavir (APV) 1200mg twice a day
amprenavir
amprenavir 1200mg twice a day
ABC 300mg b.i.d
HIV-infected pregnant women ≥ 20 weeks gestation who received abacavir (ABC) 300mg twice a day
abacavir
abacavir 300mg twice a day
LPV/RTV Arm 1: 400/100mg b.i.d
HIV-infected pregnant women ≥ 26 weeks gestation who received lopinavir/ritonavir (LPV/RTV) 400/100mg twice a day
lopinavir/ritonavir dosage #2
lopinavir/ritonavir (Kaletra) 400/100mg twice a day
IDV/RTV Arm 1: 800/100mg b.i.d
HIV-infected pregnant women ≥ 26 weeks gestation who received indinavir/ritonavir (IDV/RTV) 800/100 mg twice a day
indinavir/ritonavir dosage #1
indinavir/ritonavir 800/100mg twice a day
FPV/RTV 700/100mg b.i.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received fosamprenavir/ritonavir (FPV/RTV)700/100mg twice a day
fosamprenavir/ritonavir
fosamprenavir/ritonavir 700/100 mg twice a day
LPV/RTV Arm 2: 400/100mg b.i.d. then 533/133mg b.i.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received Kaletra (LPV/RTV) 400/100 mg twice a day until 30 weeks gestation, then 533/133 mg twice a day until results of postpartum PK evaluation were available
lopinavir/ritonavir dosage #2
lopinavir/ritonavir (Kaletra) 400/100mg twice a day
lopinavir/ritonavir dosage #3
lopinavir/ritonavir (Kaletra) 533/133 mg twice a day
ATV/RTV Arm 1: 300/100mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir (ATV/RTV) 300/100 mg once a day
atazanavir/ritonavir dosage #1
atazanavir/ritonavir 300/100 mg once a day
DDI 400mg or 250mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received didanosine delayed release (Videx® EC) (DDI) 400 mg once a day if weight \> 60 kg; 250 mg once a day if weight \< 60 kg
didanosine delayed release (Videx® EC)
didanosine delayed release (Videx® EC) 400 mg once a day if weight \> 60 kg; 250 mg once a day if weight \< 60 kg
FTC 200mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received emtricitabine (FTC) 200 mg once a day
emtricitabine
emtricitabine 200 mg once a day
TFV 300mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir (TFV) 300 mg once a day
tenofovir
tenofovir 300 mg once a day
TFV/ATV/RTV Arm 1: 300/300/100mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir (TFV/ATV/RTV) 300/300/100 mg once a day
atazanavir/ritonavir/tenofovir dosage #1
atazanavir/ritonavir/tenofovir 300/100/300mg q.d.
NFV Arm 1: 1250mg b.i.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received nelfinavir (NFV) \[625 mg tablets\] 1250 mg twice a day
nelfinavir dosage #1
nelfinavir \[625 mg tablets\] 1250 mg twice a day
EFV 600mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received efavirenz (EFV) 600 mg once a day
efavirenz
efavirenz 600 mg q.d.
TPV/RTV 500/200mg b.i.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received tipranavir/ritonavir (TPV/RTV) 500/200 mg twice a day
tipranavir/ritonavir
tipranavir/ritonavir 500/200 mg twice a day
LPV/RTV Arm 3: 400/100mg b.i.d. then 600/150mg b.i.d. then 400/100mg b.i.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (LPV/RTV) tablets 400/100 mg \[2 tablets\] twice a day until 30 weeks gestation, then 600/150 mg \[3 tablets\] twice a day until postpartum hospital discharge; and 400/100 mg \[2 tablets\] twice a day after postpartum hospital discharge, until 2 week postpartum PK sample is drawn
lopinavir/ritonavir dosage #2
lopinavir/ritonavir (Kaletra) 400/100mg twice a day
lopinavir/ritonavir dosage #4
lopinavir/ritonavir (Kaletra) tablets 600/150 mg \[3 tablets\] twice a day
RAL 400mg b.i.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received raltegravir (RAL) 400 mg twice a day
raltegravir
raltegravir 400 mg twice a day
ETR 200mg b.i.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received etravirine (ETR) 200mg twice a day
etravirine
etravirine 200 mg twice a day
MVC 150 or 300mg b.i.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received maraviroc (MVC)150 mg or 300 mg twice a day
maraviroc
maraviroc 150 mg or 300 mg twice a day
DRV/RTV 800/100mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir (DRV/RTV) 800/100 mg once a day
darunavir/ritonavir dosage #4
darunavir/ritonavir once daily 800/100 mg q.d.
DRV/RTV 600/100mg b.i.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir (DRV/RTV) 600/100 mg twice a day
darunavir/ritonavir dosage #1
darunavir/ritonavir twice daily 600/100 mg b.i.d.
ATV/RTV Arm 2: 300/100mg q.d. then 400/100mg q.d. then 300/100mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir (ATV/RTV) 300/100 mg once a day until 30 weeks gestation then 400/100 mg once a day until postpartum hospital discharge; then 300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn
atazanavir/ritonavir dosage #1
atazanavir/ritonavir 300/100 mg once a day
atazanavir/ritonavir dosage #2
atazanavir/ritonavir 400/100mg once a day
TFV/ATV/RTV Arm 2: 300/300/100mg q.d. then 300/400/100mg q.d then 300/300/100mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir (TFV/ATV/RTV) 300/300/100 mg once a day until 30 weeks gestation; then 300/400/100 mg once a day until postpartum hospital discharge; then 300/300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn
atazanavir/ritonavir/tenofovir dosage #1
atazanavir/ritonavir/tenofovir 300/100/300mg q.d.
tenofovir/atazanavir/ritonavir dosage #2
tenofovir/atazanavir/ritonavir 300/400/100 mg once a day
NFV Arm 2: 1250mg b.i.d. then 1875mg b.i.d. then 1250mg b.i.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received nelfinavir (NFV) \[625 mg tablets\] 1250 mg twice a day until 30 weeks gestation; then 1875 mg twice a day until postpartum hospital discharge; then 1250 mg twice a day after postpartum hospital discharge until 2 week postpartum PK samples drawn
nelfinavir dosage #1
nelfinavir \[625 mg tablets\] 1250 mg twice a day
nelfinavir dosage #2
nelfinavir \[625 mg tablets\] 1875 mg twice a day
IDV/RTV Arm 2: 400/100mg q.d. (only THA)
HIV-infected pregnant women ≥ 20 weeks gestation who received indinavir/ritonavir (IDV/RTV) 400/100 mg twice a day only to participants enrolling in Thailand
indinavir/ritonavir dosage #2
indinavir/ritonavir 400/100 mg twice a day
LPV/RTV Arm 4: 400/100mg b.i.d. then 600/150mg b.i.d. then 400/100mg b.i.d. (only African sites)
HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (LPV/RTV, Alluvia tablets) 400/100 mg \[2 tablets\] twice day until 30 weeks gestation; then 600/150 mg \[3 tablets\] twice a day until postpartum hospital discharge; then 400/100 mg \[2 tablets\] twice a day after postpartum hospital discharge until 2 week postpartum PK sample drawn only to participants enrolling in Uganda
lopinavir/ritonavir dosage #2
lopinavir/ritonavir (Kaletra) 400/100mg twice a day
lopinavir/ritonavir dosage #4
lopinavir/ritonavir (Kaletra) tablets 600/150 mg \[3 tablets\] twice a day
RPV 25mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received rilpivirine (RPV) (25 mg q.d.)
rilpivirine
rilpivirine (25 mg q.d.)
NVP 200mg b.i.d. and RIF and at least one 1st line TB drug
HIV-infected pregnant women \> 20 weeks gestation who received nevirapine (NVP) 200 mg b.i.d AND rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. and at least one of the following drugs at study entry:
* ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.
* isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
* pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.
ethambutol
ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.
isoniazid
isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
pyrazinamide
pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.
nevirapine
nevirapine 200 mg twice a day
ATV/RTV/TFV 300/100/300mg q.d. with ENG
HIV- infected women 2-12 weeks postpartum who received atazanavir/ritonavir/tenofovir (ATV/RTV/TFV) 300/100/300 mg q.d. postpartum and starting postpartum etonogestrel (ENG) implant
atazanavir/ritonavir/tenofovir dosage #1
atazanavir/ritonavir/tenofovir 300/100/300mg q.d.
etonogestrel implant
etonogestrel implant contraceptive
LPV/RTV 400/100 b.i.d. with 30-35ug EE
HIV- infected women 2-12 weeks postpartum who received lopinavir/ritonavir (LPV/RTV) 400/100 b.i.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol (EE)
ethinyl estradiol
oral contraceptives formulated with 30-35 μg ethinyl estradiol
lopinavir/ritonavir dosage #2
lopinavir/ritonavir (Kaletra) 400/100mg twice a day
LPV/RTV 400/100 b.i.d. with ENG
HIV- infected women 2-12 weeks postpartum who received lopinavir/ritonavir (LPV/RTV) 400/100 b.i.d. postpartum and starting postpartum etonogestrel (ENG) implant
etonogestrel implant
etonogestrel implant contraceptive
lopinavir/ritonavir dosage #2
lopinavir/ritonavir (Kaletra) 400/100mg twice a day
EFV 600mg q.d. with ENG
HIV-infected women 2-12 weeks postpartum who received efavirenz (EFV) 600mg q.d. postpartum and starting postpartum etonogestrel (ENG) implant
efavirenz
efavirenz 600 mg q.d.
etonogestrel implant
etonogestrel implant contraceptive
Interventions
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atazanavir/cobicistat
atazanavir/cobicistat 300/150 mg q.d.
darunavir/ritonavir dosage #1
darunavir/ritonavir twice daily 600/100 mg b.i.d.
darunavir/ritonavir dosage #2
darunavir/ritonavir twice daily 800/100 mg b.i.d.
darunavir/ritonavir dosage #3
darunavir/ritonavir twice daily 900/100 mg b.i.d.
elvitegravir/cobicistat
elvitegravir/cobicistat 150/150 mg q.d.
dolutegravir
dolutegravir 50 mg q.d.
tenofovir alafenamide fumarate (TAF)
TAF 25 mg q.d. without cobicistat or ritonavir boosting
TAF w/cobicistat
TAF 10 mg q.d. with cobicistat
TAF w/cobicistat or ritonavir
TAF 25 mg q.d. with cobicistat or ritonavir boosting
efavirenz
efavirenz 600 mg q.d.
darunavir/cobicistat
darunavir/cobicistat 800/150 mg q.d.
lopinavir/ritonavir dosage #1
lopinavir/ritonavir 800/200mg b.i.d.
atazanavir/ritonavir/tenofovir dosage #1
atazanavir/ritonavir/tenofovir 300/100/300mg q.d.
rifampicin
rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
ethambutol
ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.
isoniazid
isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
pyrazinamide
pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.
kanamycin
kanamycin (2nd line TB drug)
amikacin
amikacin (2nd line TB drug)
capreomycin
capreomycin (2nd line TB drug)
moxifloxacin
moxifloxacin (2nd line TB drug)
levoflaxacin
levofloxacin (2nd line TB drug)
ofloxacin
ofloxacin (2nd line TB drug)
ethionamide/prothionamide
ethionamide/prothionamide (2nd line TB drug)
terizidone/cycloserine
terizidone/cycloserine (2nd line TB drug)
para-aminosalicylic acid (PAS)
para-aminosalicylic acid (PAS) (2nd line TB drug)
high dose INH
high dose INH (2nd line TB drug)
bedaquiline
bedaquiline (2nd line TB drug)
clofazamine
clofazamine (2nd TB drug)
delamanid
delamanid (2nd line TB drug)
linezolid
linezolid (2nd line TB drug)
pretomanid
pretomanid (2nd line TB drug)
ethinyl estradiol
oral contraceptives formulated with 30-35 μg ethinyl estradiol
etonogestrel implant
etonogestrel implant contraceptive
nevirapine
nevirapine 200 mg twice a day
amprenavir
amprenavir 1200mg twice a day
abacavir
abacavir 300mg twice a day
lopinavir/ritonavir dosage #2
lopinavir/ritonavir (Kaletra) 400/100mg twice a day
indinavir/ritonavir dosage #1
indinavir/ritonavir 800/100mg twice a day
fosamprenavir/ritonavir
fosamprenavir/ritonavir 700/100 mg twice a day
lopinavir/ritonavir dosage #3
lopinavir/ritonavir (Kaletra) 533/133 mg twice a day
atazanavir/ritonavir dosage #1
atazanavir/ritonavir 300/100 mg once a day
didanosine delayed release (Videx® EC)
didanosine delayed release (Videx® EC) 400 mg once a day if weight \> 60 kg; 250 mg once a day if weight \< 60 kg
emtricitabine
emtricitabine 200 mg once a day
tenofovir
tenofovir 300 mg once a day
nelfinavir dosage #1
nelfinavir \[625 mg tablets\] 1250 mg twice a day
tipranavir/ritonavir
tipranavir/ritonavir 500/200 mg twice a day
lopinavir/ritonavir dosage #4
lopinavir/ritonavir (Kaletra) tablets 600/150 mg \[3 tablets\] twice a day
raltegravir
raltegravir 400 mg twice a day
etravirine
etravirine 200 mg twice a day
maraviroc
maraviroc 150 mg or 300 mg twice a day
atazanavir/ritonavir dosage #2
atazanavir/ritonavir 400/100mg once a day
tenofovir/atazanavir/ritonavir dosage #2
tenofovir/atazanavir/ritonavir 300/400/100 mg once a day
nelfinavir dosage #2
nelfinavir \[625 mg tablets\] 1875 mg twice a day
indinavir/ritonavir dosage #2
indinavir/ritonavir 400/100 mg twice a day
rilpivirine
rilpivirine (25 mg q.d.)
darunavir/ritonavir dosage #4
darunavir/ritonavir once daily 800/100 mg q.d.
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
* 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)
ALL
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
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 Medical Center
Locations
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UAB Pediatric Infectious Diseases CRS
Birmingham, Alabama, United States
University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program
La Jolla, California, United States
Miller Children's Hosp. Long Beach CA NICHD CRS
Long Beach, California, United States
Usc La Nichd Crs
Los Angeles, California, United States
David Geffen School of Medicine at UCLA NICHD CRS
Los Angeles, California, United States
Univ. of California San Francisco NICHD CRS
San Francisco, California, United States
Harbor UCLA Medical Ctr. NICHD CRS
Torrance, California, United States
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
New Haven, Connecticut, United States
Washington Hosp. Ctr. NICHD CRS
Washington D.C., District of Columbia, United States
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States
Pediatric Perinatal HIV Clinical Trials Unit CRS
Miami, Florida, United States
USF - Tampa NICHD CRS
Tampa, Florida, United States
Emory University School of Medicine NICHD CRS
Atlanta, Georgia, United States
Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
Augusta, Georgia, United States
Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program
Chicago, Illinois, United States
Rush Univ. Cook County Hosp. Chicago NICHD CRS
Chicago, Illinois, United States
Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
Chicago, Illinois, United States
Lurie Children's Hospital of Chicago (LCH) CRS
Chicago, Illinois, United States
Tulane Univ. New Orleans NICHD CRS
New Orleans, Louisiana, United States
Univ. of Maryland Baltimore NICHD CRS
Baltimore, Maryland, United States
Johns Hopkins Univ. Baltimore NICHD CRS
Baltimore, Maryland, United States
Children's Hosp. of Boston NICHD CRS
Boston, Massachusetts, United States
Boston Medical Center Ped. HIV Program NICHD CRS
Boston, Massachusetts, United States
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, United States
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, United States
Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, United States
Rutgers - New Jersey Medical School CRS
Newark, New Jersey, United States
Nyu Ny Nichd Crs
New York, New York, United States
Metropolitan Hosp. NICHD CRS
New York, New York, United States
Columbia IMPAACT CRS
New York, New York, United States
SUNY Stony Brook NICHD CRS
Stony Brook, New York, 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
DUMC Ped. CRS
Durham, North Carolina, United States
Philadelphia IMPAACT Unit CRS
Philadelphia, Pennsylvania, United States
Regional Med. Ctr. at Memphis
Memphis, Tennessee, United States
St. Jude Children's Research Hospital CRS
Memphis, Tennessee, United States
Seattle Children's Research Institute CRS
Seattle, Washington, United States
Hosp. General de Agudos Buenos Aires Argentina NICHD CRS
Ciudad de Buenos Aires, Buenos Aires, Argentina
Gaborone CRS
Gaborone, South-East District, Botswana
Molepolole CRS
Gaborone, , Botswana
SOM Federal University Minas Gerais Brazil NICHD CRS
Belo Horizonte, Minas Gerais, Brazil
Hosp. Santa Casa Porto Alegre Brazil NICHD CRS
Porto Alegre, Rio Grande do Sul, Brazil
Hosp. dos Servidores Rio de Janeiro NICHD CRS
Rio de Janeiro, , Brazil
Hospital Federal dos Servidores do Estado NICHD CRS
Rio de Janeiro, , Brazil
Instituto de Puericultura e Pediatria Martagao Gesteira - UFRJ NICHD CRS
Rio de Janeiro, , Brazil
Hosp. Geral De Nova Igaucu Brazil NICHD CRS
Rio de Janeiro, , Brazil
Univ. of Sao Paulo Brazil NICHD CRS
São Paulo, , Brazil
IMPAACT/ Gamma Project/ UPR Pediatric HIV/AIDS Research CRS
San Juan, , Puerto Rico
San Juan City Hosp. PR NICHD CRS
San Juan, , Puerto Rico
Wits RHI Shandukani Research Centre CRS
Johannesburg, Gauteng, South Africa
Desmond Tutu TB Centre - Stellenbosch University (DTTC-SU) CRS
Cape Town, Western Cape, South Africa
Famcru Crs
Tygerberg, Western Cape, South Africa
Kilimanjaro Christian Medical Centre (KCMC)
Moshi, , Tanzania
Bhumibol Adulyadej Hosp. CRS
Sai Mai, Bangkok, Thailand
Siriraj Hospital ,Mahidol University NICHD CRS
Bangkok, Bangkoknoi, Thailand
Phayao Provincial Hosp. CRS
T.Tom, Muang, Changwat Phayao, Thailand
Prapokklao Hosp. CRS
Chanthaburi, , Thailand
Chiangrai Prachanukroh Hospital NICHD CRS
Chiang Mai, , Thailand
Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS
Chiang Mai, , Thailand
Chonburi Hosp. CRS
Chon Buri, , Thailand
Countries
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References
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Mirochnick M, Capparelli E. Pharmacokinetics of antiretrovirals in pregnant women. Clin Pharmacokinet. 2004;43(15):1071-87. doi: 10.2165/00003088-200443150-00002.
Rakhmanina NY, van den Anker JN, Soldin SJ. Safety and pharmacokinetics of antiretroviral therapy during pregnancy. Ther Drug Monit. 2004 Apr;26(2):110-5. doi: 10.1097/00007691-200404000-00004.
Sullivan JL. Prevention of mother-to-child transmission of HIV--what next? J Acquir Immune Defic Syndr. 2003 Sep;34 Suppl 1:S67-72. doi: 10.1097/00126334-200309011-00010.
Best BM, Mirochnick M, Capparelli EV, Stek A, Burchett SK, Holland DT, Read JS, Smith E, Hu C, Spector SA, Connor JD; PACTG P1026s Study Team. Impact of pregnancy on abacavir pharmacokinetics. AIDS. 2006 Feb 28;20(4):553-60. doi: 10.1097/01.aids.0000210609.52836.d1.
Stek AM, Mirochnick M, Capparelli E, Best BM, Hu C, Burchett SK, Elgie C, Holland DT, Smith E, Tuomala R, Cotter A, Read JS. Reduced lopinavir exposure during pregnancy. AIDS. 2006 Oct 3;20(15):1931-9. doi: 10.1097/01.aids.0000247114.43714.90.
Aweeka FT, Stek A, Best BM, Hu C, Holland D, Hermes A, Burchett SK, Read J, Mirochnick M, Capparelli EV; International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) P1026s Protocol Team. Lopinavir protein binding in HIV-1-infected pregnant women. HIV Med. 2010 Apr;11(4):232-8. doi: 10.1111/j.1468-1293.2009.00767.x. Epub 2009 Dec 3.
Mirochnick M, Best BM, Stek AM, Capparelli EV, Hu C, Burchett SK, Rossi SS, Hawkins E, Basar M, Smith E, Read JS; IMPAACT 1026s Study Team. Atazanavir pharmacokinetics with and without tenofovir during pregnancy. J Acquir Immune Defic Syndr. 2011 Apr 15;56(5):412-9. doi: 10.1097/QAI.0b013e31820fd093.
Capparelli EV, Aweeka F, Hitti J, Stek A, Hu C, Burchett SK, Best B, Smith E, Read JS, Watts H, Nachman S, Thorpe EM Jr, Spector SA, Jimenez E, Shearer WT, Foca M, Mirochnick M; PACTG 1026S Study Team; PACTG P1022 Study Team. Chronic administration of nevirapine during pregnancy: impact of pregnancy on pharmacokinetics. HIV Med. 2008 Apr;9(4):214-20. doi: 10.1111/j.1468-1293.2008.00553.x.
Mirochnick M, Best BM, Stek AM, Capparelli E, Hu C, Burchett SK, Holland DT, Smith E, Gaddipati S, Read JS; PACTG 1026s Study Team. Lopinavir exposure with an increased dose during pregnancy. J Acquir Immune Defic Syndr. 2008 Dec 15;49(5):485-91. doi: 10.1097/QAI.0b013e318186edd0.
Read JS, Best BM, Stek AM, Hu C, Capparelli EV, Holland DT, Burchett SK, Smith ME, Sheeran EC, Shearer WT, Febo I, Mirochnick M. Pharmacokinetics of new 625 mg nelfinavir formulation during pregnancy and postpartum. HIV Med. 2008 Nov;9(10):875-82. doi: 10.1111/j.1468-1293.2008.00640.x. Epub 2008 Sep 14.
Best BM, Stek AM, Mirochnick M, Hu C, Li H, Burchett SK, Rossi SS, Smith E, Read JS, Capparelli EV; International Maternal Pediatric Adolescent AIDS Clinical Trials Group 1026s Study Team. Lopinavir tablet pharmacokinetics with an increased dose during pregnancy. J Acquir Immune Defic Syndr. 2010 Aug;54(4):381-8. doi: 10.1097/qai.0b013e3181d6c9ed.
Stek AM, Best BM, Luo W, Capparelli E, Burchett S, Hu C, Li H, Read JS, Jennings A, Barr E, Smith E, Rossi SS, Mirochnick M. Effect of pregnancy on emtricitabine pharmacokinetics. HIV Med. 2012 Apr;13(4):226-35. doi: 10.1111/j.1468-1293.2011.00965.x. Epub 2011 Nov 30.
Cressey TR, Stek A, Capparelli E, Bowonwatanuwong C, Prommas S, Sirivatanapa P, Yuthavisuthi P, Neungton C, Huo Y, Smith E, Best BM, Mirochnick M; IMPAACT P1026s Team. Efavirenz pharmacokinetics during the third trimester of pregnancy and postpartum. J Acquir Immune Defic Syndr. 2012 Mar 1;59(3):245-52. doi: 10.1097/QAI.0b013e31823ff052.
Cressey TR, Best BM, Achalapong J, Stek A, Wang J, Chotivanich N, Yuthavisuthi P, Suriyachai P, Prommas S, Shapiro DE, Watts DH, Smith E, Capparelli E, Kreitchmann R, Mirochnick M; IMPAACT P1026s team. Reduced indinavir exposure during pregnancy. Br J Clin Pharmacol. 2013 Sep;76(3):475-83. doi: 10.1111/bcp.12078.
Kreitchmann R, Best BM, Wang J, Stek A, Caparelli E, Watts DH, Smith E, Shapiro DE, Rossi S, Burchett SK, Hawkins E, Byroads M, Cressey TR, Mirochnick M. Pharmacokinetics of an increased atazanavir dose with and without tenofovir during the third trimester of pregnancy. J Acquir Immune Defic Syndr. 2013 May 1;63(1):59-66. doi: 10.1097/QAI.0b013e318289b4d2.
Watts DH, Stek A, Best BM, Wang J, Capparelli EV, Cressey TR, Aweeka F, Lizak P, Kreitchmann R, Burchett SK, Shapiro DE, Hawkins E, Smith E, Mirochnick M; IMPAACT 1026s study team. Raltegravir pharmacokinetics during pregnancy. J Acquir Immune Defic Syndr. 2014 Dec 1;67(4):375-81. doi: 10.1097/QAI.0000000000000318.
Cressey TR, Urien S, Capparelli EV, Best BM, Buranabanjasatean S, Limtrakul A, Rawangban B, Sabsanong P, Treluyer JM, Jourdain G, Stek A, Lallemant M, Mirochnick M. Impact of body weight and missed doses on lopinavir concentrations with standard and increased lopinavir/ritonavir doses during late pregnancy. J Antimicrob Chemother. 2015 Jan;70(1):217-24. doi: 10.1093/jac/dku367. Epub 2014 Sep 25.
Aweeka FT, Hu C, Huang L, Best BM, Stek A, Lizak P, Burchett SK, Read JS, Watts H, Mirochnick M, Capparelli EV; International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) P1026s Protocol Team. Alteration in cytochrome P450 3A4 activity as measured by a urine cortisol assay in HIV-1-infected pregnant women and relationship to antiretroviral pharmacokinetics. HIV Med. 2015 Mar;16(3):176-83. doi: 10.1111/hiv.12195. Epub 2014 Nov 18.
Colbers A, Best B, Schalkwijk S, Wang J, Stek A, Hidalgo Tenorio C, Hawkins D, Taylor G, Kreitchmann R, Burchett S, Haberl A, Kabeya K, van Kasteren M, Smith E, Capparelli E, Burger D, Mirochnick M; PANNA Network and the IMPAACT 1026 Study Team. Maraviroc Pharmacokinetics in HIV-1-Infected Pregnant Women. Clin Infect Dis. 2015 Nov 15;61(10):1582-9. doi: 10.1093/cid/civ587. Epub 2015 Jul 22.
Best BM, Burchett S, Li H, Stek A, Hu C, Wang J, Hawkins E, Byroads M, Watts DH, Smith E, Fletcher CV, Capparelli EV, Mirochnick M; International Maternal Pediatric and Adolescent AIDS Clinical Trials (IMPAACT) P1026s Team. Pharmacokinetics of tenofovir during pregnancy and postpartum. HIV Med. 2015 Sep;16(8):502-11. doi: 10.1111/hiv.12252. Epub 2015 May 11.
Stek A, Best BM, Wang J, Capparelli EV, Burchett SK, Kreitchmann R, Rungruengthanakit K, Cressey TR, Mofenson LM, Smith E, Shapiro D, Mirochnick M. Pharmacokinetics of Once Versus Twice Daily Darunavir in Pregnant HIV-Infected Women. J Acquir Immune Defic Syndr. 2015 Sep 1;70(1):33-41. doi: 10.1097/QAI.0000000000000668.
Tran AH, Best BM, Stek A, Wang J, Capparelli EV, Burchett SK, Kreitchmann R, Rungruengthanakit K, George K, Cressey TR, Chakhtoura N, Smith E, Shapiro DE, Mirochnick M; IMPAACT P1026s Protocol Team. Pharmacokinetics of Rilpivirine in HIV-Infected Pregnant Women. J Acquir Immune Defic Syndr. 2016 Jul 1;72(3):289-96. doi: 10.1097/QAI.0000000000000968.
Mulligan N, Schalkwijk S, Best BM, Colbers A, Wang J, Capparelli EV, Molto J, Stek AM, Taylor G, Smith E, Hidalgo Tenorio C, Chakhtoura N, van Kasteren M, Fletcher CV, Mirochnick M, Burger D. Etravirine Pharmacokinetics in HIV-Infected Pregnant Women. Front Pharmacol. 2016 Aug 4;7:239. doi: 10.3389/fphar.2016.00239. eCollection 2016.
Mulligan N, Best BM, Wang J, Capparelli EV, Stek A, Barr E, Buschur SL, Acosta EP, Smith E, Chakhtoura N, Burchett S, Mirochnick M; IMPAACT P1026s Protocol Team. Dolutegravir pharmacokinetics in pregnant and postpartum women living with HIV. AIDS. 2018 Mar 27;32(6):729-737. doi: 10.1097/QAD.0000000000001755.
Schalkwijk S, Ter Heine R, Colbers AC, Huitema ADR, Denti P, Dooley KE, Capparelli E, Best BM, Cressey TR, Greupink R, Russel FGM, Mirochnick M, Burger DM. A Mechanism-Based Population Pharmacokinetic Analysis Assessing the Feasibility of Efavirenz Dose Reduction to 400 mg in Pregnant Women. Clin Pharmacokinet. 2018 Nov;57(11):1421-1433. doi: 10.1007/s40262-018-0642-9.
Eke AC, Chakhtoura N, Kashuba A, Best BM, Sykes C, Wang J, Stek AM, Smith E, Calabrese S, Capparelli EV, Mirochnick M; IMPAACT P1026s Protocol Team. Rilpivirine Plasma and Cervicovaginal Concentrations in Women During Pregnancy and Postpartum. J Acquir Immune Defic Syndr. 2018 Jul 1;78(3):308-313. doi: 10.1097/QAI.0000000000001677.
Momper JD, Best BM, Wang J, Capparelli EV, Stek A, Barr E, Badell ML, Acosta EP, Purswani M, Smith E, Chakhtoura N, Park K, Burchett S, Shapiro DE, Mirochnick M; IMPAACT P1026s Protocol Team. Elvitegravir/cobicistat pharmacokinetics in pregnant and postpartum women with HIV. AIDS. 2018 Nov 13;32(17):2507-2516. doi: 10.1097/QAD.0000000000001992.
Eke AC, McCormack SA, Best BM, Stek AM, Wang J, Kreitchmann R, Shapiro D, Smith E, Mofenson LM, Capparelli EV, Mirochnick M; IMPAACT P1026s Protocol Team. Pharmacokinetics of Increased Nelfinavir Plasma Concentrations in Women During Pregnancy and Postpartum. J Clin Pharmacol. 2019 Mar;59(3):386-393. doi: 10.1002/jcph.1331. Epub 2018 Oct 25.
Kreitchmann R, Schalkwijk S, Best B, Wang J, Colbers A, Stek A, Shapiro D, Cressey T, Mirochnick M, Burger D. Efavirenz pharmacokinetics during pregnancy and infant washout. Antivir Ther. 2019;24(2):95-103. doi: 10.3851/IMP3283.
Schalkwijk S, Ter Heine R, Colbers A, Capparelli E, Best BM, Cressey TR, Greupink R, Russel FGM, Molto J, Mirochnick M, Karlsson MO, Burger DM. Evaluating darunavir/ritonavir dosing regimens for HIV-positive pregnant women using semi-mechanistic pharmacokinetic modelling. J Antimicrob Chemother. 2019 May 1;74(5):1348-1356. doi: 10.1093/jac/dky567.
Liu XI, Momper JD, Rakhmanina N, van den Anker JN, Green DJ, Burckart GJ, Best BM, Mirochnick M, Capparelli EV, Dallmann A. Physiologically Based Pharmacokinetic Models to Predict Maternal Pharmacokinetics and Fetal Exposure to Emtricitabine and Acyclovir. J Clin Pharmacol. 2020 Feb;60(2):240-255. doi: 10.1002/jcph.1515. Epub 2019 Sep 6.
Eke AC, Wang J, Amin K, Shapiro DE, Stek A, Smith E, Chakhtoura N, Basar M, George K, Knapp KM, Joao EC, Rungruengthanakit K, Capparelli E, Burchett S, Mirochnick M, Best BM; P1026s Protocol Team. Fosamprenavir with Ritonavir Pharmacokinetics during Pregnancy. Antimicrob Agents Chemother. 2020 Mar 24;64(4):e02260-19. doi: 10.1128/AAC.02260-19. Print 2020 Mar 24.
Liu XI, Momper JD, Rakhmanina NY, Green DJ, Burckart GJ, Cressey TR, Mirochnick M, Best BM, van den Anker JN, Dallmann A. Prediction of Maternal and Fetal Pharmacokinetics of Dolutegravir and Raltegravir Using Physiologically Based Pharmacokinetic Modeling. Clin Pharmacokinet. 2020 Nov;59(11):1433-1450. doi: 10.1007/s40262-020-00897-9.
Brooks KM, Momper JD, Pinilla M, Stek AM, Barr E, Weinberg A, Deville JG, Febo IL, Cielo M, George K, Denson K, Rungruengthanakit K, Shapiro DE, Smith E, Chakhtoura N, Rooney JF, Haubrich R, Espina R, Capparelli EV, Mirochnick M, Best BM; IMPAACT P1026s Protocol Team. Pharmacokinetics of tenofovir alafenamide with and without cobicistat in pregnant and postpartum women living with HIV. AIDS. 2021 Mar 1;35(3):407-417. doi: 10.1097/QAD.0000000000002767.
Eke AC, Shoji K, Best BM, Momper JD, Stek AM, Cressey TR, Mirochnick M, Capparelli EV. Population Pharmacokinetics of Tenofovir in Pregnant and Postpartum Women Using Tenofovir Disoproxil Fumarate. Antimicrob Agents Chemother. 2021 Feb 17;65(3):e02168-20. doi: 10.1128/AAC.02168-20. Print 2021 Feb 17.
Momper JD, Wang J, Stek A, Shapiro DE, Scott GB, Paul ME, Febo IL, Burchett S, Smith E, Chakhtoura N, Denson K, Rungruengthanakit K, George K, Yang DZ, Capparelli EV, Mirochnick M, Best BM; IMPAACT P1026s Protocol Team. Pharmacokinetics of darunavir and cobicistat in pregnant and postpartum women with HIV. AIDS. 2021 Jul 1;35(8):1191-1199. doi: 10.1097/QAD.0000000000002857.
Momper JD, Wang J, Stek A, Shapiro DE, Powis KM, Paul ME, Badell ML, Browning R, Chakhtoura N, Denson K, Rungruengthanakit K, George K, Capparelli EV, Mirochnick M, Best BM; IMPAACT P1026s Protocol Team. Pharmacokinetics of Atazanavir Boosted With Cobicistat in Pregnant and Postpartum Women With HIV. J Acquir Immune Defic Syndr. 2022 Mar 1;89(3):303-309. doi: 10.1097/QAI.0000000000002856.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol: P1026s Protocol Version 10.0_02Feb2016
Document Type: Study Protocol: P1026s Protocol Version 10.0_Letter of Amendment 1_14Dec2016
Document Type: Study Protocol: P1026s Protocol Version 10.0_Letter of Amendment 2_13Apr2018
Document Type: Statistical Analysis Plan: PK SAP
Document Type: Statistical Analysis Plan: Primary SAP
Document Type: Informed Consent Form
Related Links
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Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (Corrected Version 2.1 - July 2017)
Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010
Other Identifiers
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P1026s
Identifier Type: -
Identifier Source: org_study_id
10040
Identifier Type: REGISTRY
Identifier Source: secondary_id
IMPAACT P1026s
Identifier Type: -
Identifier Source: secondary_id
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