Blood Levels of Anti-HIV Drugs Used in Combination Regimens in HIV Infected Children

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

February 28, 2006

Primary Completion Date

April 30, 2009

Study Completion Date

April 30, 2009

Conditions
HIV Infections
Interventions
DRUG

Atazanavir

200 mg to 400 mg orally daily

DRUG

Darunavir

300 mg or 600 mg orally twice daily

DRUG

Efavirenz

Dosage dependent on participant

DRUG

Nevirapine

Dosage dependent on participant

DRUG

Ritonavir

50 mg or 100 mg orally twice daily

DRUG

Tenofovir disoproxil fumarate

300 mg orally daily

PROCEDURE

Pharmacokinetic Study

Intensive PK study will occur at least once. This will require a 24-hour inpatient visit.

Trial Locations (23)

10016

Nyu Ny Nichd Crs, New York

10461

Jacobi Med. Ctr. Bronx NICHD CRS, The Bronx

11203

SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS, Brooklyn

21201

Univ. of Maryland Baltimore NICHD CRS, Baltimore

21287

Johns Hopkins Univ. Baltimore NICHD CRS, Baltimore

27710

DUMC Ped. CRS, Durham

33136

Pediatric Perinatal HIV Clinical Trials Unit CRS, Miami

48201

Children's Hospital of Michigan NICHD CRS, Detroit

60612

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

90502

Harbor UCLA Medical Ctr. NICHD CRS, Torrance

90806

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

91803

Usc La Nichd Crs, Alhambra

98105

Seattle Children's Hospital CRS, Seattle

92093-0672

University of California, UC San Diego CRS, La Jolla

06106

Connecticut Children's Med. Ctr., Hartford

60614-3393

Ann & Robert H. Lurie Children's Hospital of Chicago (LCH) CRS, Chicago

02115

Children's Hosp. of Boston 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

00935

University of Puerto Rico Pediatric HIV/AIDS Research Program 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

NCT00260078 - Blood Levels of Anti-HIV Drugs Used in Combination Regimens in HIV Infected Children | Biotech Hunter | Biotech Hunter