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

CompletedOBSERVATIONAL
Enrollment

1,578

Participants

Timeline

Start Date

June 9, 2003

Primary Completion Date

September 30, 2020

Study Completion Date

September 30, 2020

Conditions
HIV Infections
Interventions
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.

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.

Trial Locations (62)

2001

Wits RHI Shandukani Research Centre CRS, Johannesburg

7505

Desmond Tutu TB Centre - Stellenbosch University (DTTC-SU) CRS, Cape Town

Famcru Crs, Tygerberg

10016

Nyu Ny Nichd Crs, New York

10029

Metropolitan Hosp. NICHD CRS, New York

10032

Columbia IMPAACT CRS, New York

10220

Bhumibol Adulyadej Hosp. CRS, Sai Mai

10457

Bronx-Lebanon Hospital Center NICHD CRS, The Bronx

10461

Jacobi Med. Ctr. Bronx NICHD CRS, The Bronx

10700

Siriraj Hospital ,Mahidol University NICHD CRS, Bangkok

11794

SUNY Stony Brook NICHD CRS, Stony Brook

19104

Philadelphia IMPAACT Unit CRS, Philadelphia

20000

Chonburi Hosp. CRS, Chon Buri

20010

Washington Hosp. Ctr. NICHD CRS, Washington D.C.

21201

Univ. of Maryland Baltimore NICHD CRS, Baltimore

21287

Johns Hopkins Univ. Baltimore NICHD CRS, Baltimore

22000

Prapokklao Hosp. CRS, Chanthaburi

26030

Hosp. Geral De Nova Igaucu Brazil NICHD CRS, Rio de Janeiro

27710

DUMC Ped. CRS, Durham

30322

Emory University School of Medicine NICHD CRS, Atlanta

30912

Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases, Augusta

32209

Univ. of Florida Jacksonville NICHD CRS, Jacksonville

33136

Pediatric Perinatal HIV Clinical Trials Unit CRS, Miami

33606

USF - Tampa NICHD CRS, Tampa

35233

UAB Pediatric Infectious Diseases CRS, Birmingham

38103

Regional Med. Ctr. at Memphis, Memphis

48201

Children's Hospital of Michigan NICHD CRS, Detroit

50100

Chiangrai Prachanukroh Hospital NICHD CRS, Chiang Mai

50200

Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS, Chiang Mai

56000

Phayao Provincial Hosp. CRS, T.Tom, Muang

60608

Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program, Chicago

60612

Rush Univ. Cook County Hosp. Chicago NICHD CRS, Chicago

Univ. of Illinois College of Medicine at Chicago, Dept. of Peds., Chicago

70112

Tulane Univ. New Orleans NICHD CRS, New Orleans

80045

Univ. of Colorado Denver NICHD CRS, Aurora

90089

Usc La Nichd Crs, Los Angeles

90502

Harbor UCLA Medical Ctr. NICHD CRS, Torrance

90806

Miller Children's Hosp. Long Beach CA NICHD CRS, Long Beach

94143

Univ. of California San Francisco NICHD CRS, San Francisco

98101

Seattle Children's Research Institute CRS, Seattle

92093-0672

University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program, La Jolla

90095-1752

David Geffen School of Medicine at UCLA NICHD CRS, Los Angeles

06510

Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease, New Haven

60614-3393

Lurie Children's Hospital of Chicago (LCH) CRS, Chicago

02115

Children's Hosp. of Boston NICHD CRS, Boston

02118

Boston Medical Center Ped. HIV Program NICHD CRS, Boston

01199

Baystate Health, Baystate Med. Ctr., Springfield

01605

WNE Maternal Pediatric Adolescent AIDS CRS, Worcester

07103

Rutgers - New Jersey Medical School CRS, Newark

38105-3678

St. Jude Children's Research Hospital CRS, Memphis

C1221ADC

Hosp. General de Agudos Buenos Aires Argentina NICHD CRS, Ciudad de Buenos Aires

Unknown

Gaborone CRS, Gaborone

Molepolole CRS, Gaborone

Kilimanjaro Christian Medical Centre (KCMC), Moshi

30.130-100

SOM Federal University Minas Gerais Brazil NICHD CRS, Belo Horizonte

90020-090

Hosp. Santa Casa Porto Alegre Brazil NICHD CRS, Porto Alegre

20221-903

Hosp. dos Servidores Rio de Janeiro NICHD CRS, Rio de Janeiro

Hospital Federal dos Servidores do Estado NICHD CRS, Rio de Janeiro

21941-612

Instituto de Puericultura e Pediatria Martagao Gesteira - UFRJ NICHD CRS, Rio de Janeiro

14049-900

Univ. of Sao Paulo Brazil NICHD CRS, São Paulo

00935

IMPAACT/ Gamma Project/ UPR Pediatric HIV/AIDS Research CRS, San Juan

00936

San Juan City Hosp. PR NICHD CRS, San Juan

All Listed Sponsors
collaborator

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

NIH

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT00042289 - Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy | Biotech Hunter | Biotech Hunter