At a glance
ClinicalIndex Comparison Record- ✓HIV-infected pregnant women ≥20 weeks gestation receiving specified ARV drugs (with or without TB treatment)
- ✓HIV-uninfected pregnant women ≥20 weeks gestation receiving ≥2 first-line TB drugs
- ✓HIV-infected or uninfected pregnant women ≥20 weeks gestation receiving ≥2 second-line TB drugs
- ✓HIV-infected postpartum women 2-12 weeks post-delivery on ARV drugs and starting postpartum contraceptives
- ✕Women on medicines that interfere with absorption, metabolism, or clearance of study drugs (rifampicin permitted for TB/ARV interaction evaluation)
- ✕Carrying multiple fetuses
- ✕Clinical or laboratory toxicity requiring change in medicine regimen during study period
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum
In Brief
An observational study evaluating atazanavir/cobicistat, darunavir/ritonavir dosage #1, and 55 other interventions for HIV Infections. Completed, enrolled 1,578 participants across 62 sites in 8 countries.
Detailed Summary
IMPAACT P1026s is a Phase IV prospective clinical study to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study also evaluated the PKs of certain ARVs in postpartum women before and after starting hormonal contraceptives. The PKs of these drugs were evaluated by measuring the amount of medicine present in blood and/or vaginal secretions.
Study Details
Timeline
Interventions
atazanavir/cobicistat 300/150 mg q.d.
darunavir/ritonavir twice daily 600/100 mg b.i.d.
darunavir/ritonavir twice daily 800/100 mg b.i.d.
darunavir/ritonavir twice daily 900/100 mg b.i.d.
elvitegravir/cobicistat 150/150 mg q.d.
dolutegravir 50 mg q.d.
TAF 25 mg q.d. without cobicistat or ritonavir boosting
TAF 10 mg q.d. with cobicistat
TAF 25 mg q.d. with cobicistat or ritonavir boosting
efavirenz 600 mg q.d.
darunavir/cobicistat 800/150 mg q.d.
lopinavir/ritonavir 800/200mg b.i.d.
atazanavir/ritonavir/tenofovir 300/100/300mg q.d.
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.
kanamycin (2nd line TB drug)
amikacin (2nd line TB drug)
capreomycin (2nd line TB drug)
moxifloxacin (2nd line TB drug)
levofloxacin (2nd line TB drug)
ofloxacin (2nd line TB drug)
ethionamide/prothionamide (2nd line TB drug)
terizidone/cycloserine (2nd line TB drug)
para-aminosalicylic acid (PAS) (2nd line TB drug)
high dose INH (2nd line TB drug)
bedaquiline (2nd line TB drug)
clofazamine (2nd TB drug)
delamanid (2nd line TB drug)
linezolid (2nd line TB drug)
pretomanid (2nd line TB drug)
oral contraceptives formulated with 30-35 μg ethinyl estradiol
etonogestrel implant contraceptive
nevirapine 200 mg twice a day
amprenavir 1200mg twice a day
abacavir 300mg twice a day
lopinavir/ritonavir (Kaletra) 400/100mg twice a day
indinavir/ritonavir 800/100mg twice a day
fosamprenavir/ritonavir 700/100 mg twice a day
lopinavir/ritonavir (Kaletra) 533/133 mg twice a day
atazanavir/ritonavir 300/100 mg once a day
didanosine delayed release (Videx® EC) 400 mg once a day if weight \> 60 kg; 250 mg once a day if weight \< 60 kg
emtricitabine 200 mg once a day
tenofovir 300 mg once a day
nelfinavir \[625 mg tablets\] 1250 mg twice a day
tipranavir/ritonavir 500/200 mg twice a day
lopinavir/ritonavir (Kaletra) tablets 600/150 mg \[3 tablets\] twice a day
raltegravir 400 mg twice a day
etravirine 200 mg twice a day
maraviroc 150 mg or 300 mg twice a day
atazanavir/ritonavir 400/100mg once a day
tenofovir/atazanavir/ritonavir 300/400/100 mg once a day
nelfinavir \[625 mg tablets\] 1875 mg twice a day
indinavir/ritonavir 400/100 mg twice a day
rilpivirine (25 mg q.d.)
darunavir/ritonavir once daily 800/100 mg q.d.