IMPAACT P1058A: Pharmacokinetic Effects of New Antiretroviral Drugs on Children, Adolescents and Young Adults

CompletedOBSERVATIONAL
Enrollment

168

Participants

Timeline

Start Date

August 31, 2002

Primary Completion Date

March 31, 2014

Study Completion Date

March 31, 2014

Conditions
HIV Infections
Interventions
DRUG

Raltegravir (RAL)

400 mg twice daily (BID)

DRUG

Atazanavir (ATV)

300 mg daily

DRUG

Ritonavir (RTV)

100 mg daily, dosing by weight in Group I

DRUG

Tenofovir (TDF)

300 mg daily

DRUG

Etravirine (ETV)

200 mg BID

DRUG

Darunavir (DRV)

Dosing by weight

DRUG

Maraviroc (MVC)

150 mg BID in groups J and K; 600 mg BID in group L

DRUG

Lopinavir/ritonavir (LPV/r)

Coformulation of 400 mg lopinavir and 100 mg ritonavir, taken twice daily

Trial Locations (35)

10016

New York University NY (5012), New York

10029

Metropolitan Hospital (5003), New York

10032

Columbia IMPAACT CRS (4101), New York

10457

Bronx-Lebanon Hospital (6901), The Bronx

10461

Jacobi Medical Center Bronx (5013), The Bronx

11794

SUNY Stony Brook NICHD CRS (5040), Stony Brook

19104

The Children's Hosp. of Philadelphia IMPAACT CRS (6701), Philadelphia

20010

Children's National Medical Center (5015), Washington D.C.

21201

University of Maryland NICHD CRS (5094), Baltimore

21287

Johns Hopkins University NICHD CRS (5092), Baltimore

27710

Duke University Medical Center (DUMC) (4701), Durham

33136

University of Miami Pediatric Perinatal HIV/AIDS CRS (4201), Miami

33316

South Florida CDC Ft Lauderdale NICHD CRS (5055), Fort Lauderdale

33620

University of South Florida Tampa (5018), Tampa

35294

Univ. of Alabama Birmingham NICHD CRS (5096), Birmingham

38105

St. Jude/UTHSC CRS (6501), Memphis

60612

Rush University Cook County (5083), Chicago

60614

Chicago Children's CRS (4001), Chicago

77030

Texas Children's Hosp. CRS (3801), Houston

90033

Usc La Nichd Crs (5048), Los Angeles

90509

Harbor (UCLA) Medical Center NICHD CRS (5045), Torrance

Harbor Univeristy of California, Los Angeles (UCLA) Medical Center (603), Torrance

90806

Miller Children's Hospital Long Beach, CA NICHD CRS (5093), Long Beach

92103

UCSD Mother, Child & Adolescent HIV Program(4601), San Diego

94117

Univ. of California San Francisco NICHD CRS (5091), San Francisco

98105

Harborview Medical Center NICHD CRS (5027), Seattle

Univ of Washington Children's Hospital Seattle (5017), Seattle

University of Washington NICHD CRS (5029), Seattle

80218-1088

Childrens Hospital (U. Colorado, Denver) NICHD CRS (5052), Denver

02115

Children's Hospital of Boston NICHD CRS (5009), Boston

02118

Boston Medical Center Ped. HIV Program NICHD CRS (5011), Boston

01605

WNE Maternal Pediatric Adolescent AIDS CRS (7301), Worcester

07103

New Jersey Medical School (NJ) (2802), Newark

00927

San Juan City Hosp. PR NICHD CRS (5031), San Juan

00936-5067

University of Puerto Rico Pediatric HIV/AIDS Research (6601), San Juan

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

NETWORK

NCT00977756 - IMPAACT P1058A: Pharmacokinetic Effects of New Antiretroviral Drugs on Children, Adolescents and Young Adults | Biotech Hunter | Biotech Hunter