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

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.

Conditions

• HIV Infections

Interventions

DRUG

darunavir/ritonavir dosage #3

darunavir/ritonavir twice daily 900/100 mg b.i.d.

DRUG

elvitegravir/cobicistat

elvitegravir/cobicistat 150/150 mg q.d.

DRUG

dolutegravir

dolutegravir 50 mg q.d.

DRUG

tenofovir alafenamide fumarate (TAF)

TAF 25 mg q.d. without cobicistat or ritonavir boosting

DRUG

TAF w/cobicistat

TAF 10 mg q.d. with cobicistat

DRUG

TAF w/cobicistat or ritonavir

TAF 25 mg q.d. with cobicistat or ritonavir boosting

DRUG

efavirenz

efavirenz 600 mg q.d.

DRUG

darunavir/cobicistat

darunavir/cobicistat 800/150 mg q.d.

DRUG

lopinavir/ritonavir dosage #1

lopinavir/ritonavir 800/200mg b.i.d.

DRUG

atazanavir/ritonavir/tenofovir dosage #1

atazanavir/ritonavir/tenofovir 300/100/300mg q.d.

DRUG

rifampicin

rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.

DRUG

ethambutol

ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.

DRUG

isoniazid

isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.

DRUG

pyrazinamide

pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.

DRUG

kanamycin

kanamycin (2nd line TB drug)

DRUG

amikacin

amikacin (2nd line TB drug)

DRUG

capreomycin

capreomycin (2nd line TB drug)

DRUG

moxifloxacin

moxifloxacin (2nd line TB drug)

DRUG

levoflaxacin

levofloxacin (2nd line TB drug)

DRUG

ofloxacin

ofloxacin (2nd line TB drug)

DRUG

ethionamide/prothionamide

ethionamide/prothionamide (2nd line TB drug)

DRUG

terizidone/cycloserine

terizidone/cycloserine (2nd line TB drug)

DRUG

para-aminosalicylic acid (PAS)

para-aminosalicylic acid (PAS) (2nd line TB drug)

DRUG

high dose INH

high dose INH (2nd line TB drug)

DRUG

bedaquiline

bedaquiline (2nd line TB drug)

DRUG

clofazamine

clofazamine (2nd TB drug)

DRUG

delamanid

delamanid (2nd line TB drug)

DRUG

linezolid

linezolid (2nd line TB drug)

DRUG

pretomanid

pretomanid (2nd line TB drug)

DRUG

ethinyl estradiol

oral contraceptives formulated with 30-35 μg ethinyl estradiol

DRUG

etonogestrel implant

etonogestrel implant contraceptive

DRUG

nevirapine

nevirapine 200 mg twice a day

DRUG

amprenavir

amprenavir 1200mg twice a day

DRUG

abacavir

abacavir 300mg twice a day

DRUG

lopinavir/ritonavir dosage #2

lopinavir/ritonavir (Kaletra) 400/100mg twice a day

DRUG

indinavir/ritonavir dosage #1

indinavir/ritonavir 800/100mg twice a day

DRUG

fosamprenavir/ritonavir

fosamprenavir/ritonavir 700/100 mg twice a day

DRUG

lopinavir/ritonavir dosage #3

lopinavir/ritonavir (Kaletra) 533/133 mg twice a day

DRUG

atazanavir/ritonavir dosage #1

atazanavir/ritonavir 300/100 mg once a day

DRUG

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

DRUG

emtricitabine

emtricitabine 200 mg once a day

DRUG

tenofovir

tenofovir 300 mg once a day

DRUG

nelfinavir dosage #1

nelfinavir \[625 mg tablets\] 1250 mg twice a day

DRUG

tipranavir/ritonavir

tipranavir/ritonavir 500/200 mg twice a day

DRUG

lopinavir/ritonavir dosage #4

lopinavir/ritonavir (Kaletra) tablets 600/150 mg \[3 tablets\] twice a day

DRUG

raltegravir

raltegravir 400 mg twice a day

DRUG

etravirine

etravirine 200 mg twice a day

DRUG

maraviroc

maraviroc 150 mg or 300 mg twice a day

DRUG

atazanavir/ritonavir dosage #2

atazanavir/ritonavir 400/100mg once a day

DRUG

tenofovir/atazanavir/ritonavir dosage #2

tenofovir/atazanavir/ritonavir 300/400/100 mg once a day

DRUG

nelfinavir dosage #2

nelfinavir \[625 mg tablets\] 1875 mg twice a day

DRUG

indinavir/ritonavir dosage #2

indinavir/ritonavir 400/100 mg twice a day

DRUG

rilpivirine

rilpivirine (25 mg q.d.)

DRUG

darunavir/ritonavir dosage #4

darunavir/ritonavir once daily 800/100 mg q.d.

DRUG

atazanavir/cobicistat

atazanavir/cobicistat 300/150 mg q.d.

DRUG

darunavir/ritonavir dosage #1

darunavir/ritonavir twice daily 600/100 mg b.i.d.

DRUG

darunavir/ritonavir dosage #2

darunavir/ritonavir twice daily 800/100 mg b.i.d.

Sponsors & Collaborators

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

  collaborator NIH

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Mark Mirochnick, MD · Boston Medical Center

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2003-06-09

Primary Completion

2020-09-30

Completion

2020-09-30

Countries

• United States
• Argentina
• Botswana
• Brazil
• Puerto Rico
• South Africa
• Tanzania
• Thailand

Study Locations