IMPAACT P1058A: Intensive Pharmacokinetic Studies of New Classes of Antiretroviral Drug Combinations in Children, Adolescents and Young Adults
Sponsor study identifier
Secondary identifiers
NIH
observational
168
2 countries
35
Study Start
August 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2014
Actual (reported)Study Completion
March 2014
Actual (reported)This study will examine drug and body interactions in children receiving anti-HIV treatment regimens using new medications. Drug regimens to be examined will feature the medications raltegravir (RAL), maraviroc (MVC), and etravirine (ETV). These drugs will not be provided through the study.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2002
Date type not reportedThis date has not been verified as actual or estimated.
September 15, 2009
Actual (reported)September 16, 2009
Actual (reported)March 2014
Actual (reported)March 2014
Actual (reported)Steady state pharmacokinetics (PK) of raltegravir administered in combination with atazanavir/ritonavir or tenofovir or maraviroc/etravirine to older children, adolescents and young adults
Measured at baseline and 1, 2, 4, 6, 8, and 12 hours after dosing
Steady state PK of etravirine administered to older children, adolescents and young adults
Measured at baseline and 1, 2, 4, 6, 8, and 12 hours after dosing
Steady state PK of maraviroc administered in combination with atazanavir/ritonavir or lopinavir/ritonavir to older children, adolescents and young adults
Measured at baseline and 1, 2, 4, 6, 8, and 12 hours after dosing
Steady state PK of maraviroc (600 mg twice daily [BID]) given in combination with raltegravir and etravirine (a protease inhibitor [PI]-sparing regimen) to older children, adolescents and young adults
Measured at baseline and 1, 2, 4, 6, 8, and 12 hours after dosing
Relationship between Tanner stage and the PK of the regimens of interest in children and adolescents
Measured at baseline and 1, 2, 4, 6, 8, and 12 hours after dosing
Relationships between the PK parameters and polymorphisms that may affect the antiretrovirals (ARVs) of interest in older children, adolescents and young adults
Measured at baseline and 1, 2, 4, 6, 8, and 12 hours after dosing
Adverse events associated with the ARVs of interest
Measured throughout
Steady state PK of darunavir/ritonavir administered to older children, adolescents and young adults
Measured at baseline and 1, 2, 4, 6, 8, and 12 hours after dosing
Participants will receive a medication regimen including RAL + ATV + RTV.
Participants will receive a medication regimen including RAL + TDF.
Participants will receive a medication regimen including ETV + DRV + RTV.
Participants will receive a medication regimen including MVC + ATV + RTV.
400 mg twice daily (BID)
300 mg daily
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Lopinavir/ritonavir (LPV/r)
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordHIV infected children, adolescents and young adults who are receiving a regimen of antiretroviral drugs prescribed by their physician that includes one of the target combinations.
Univ. of Alabama Birmingham NICHD CRS (5096)
Birmingham, Alabama, 35294, United States
Miller Children's Hospital Long Beach, CA NICHD CRS (5093)
Long Beach, California, 90806, United States
Usc La Nichd Crs (5048)
Los Angeles, California, 90033, United States
UCSD Mother, Child & Adolescent HIV Program(4601)
San Diego, California, 92103, United States
Univ. of California San Francisco NICHD CRS (5091)
San Francisco, California, 94117, United States
Harbor (UCLA) Medical Center NICHD CRS (5045)
Torrance, California, 90509, United States
Guidelines for the use of antiretroviral agents in pediatric HIV infection. Center for Disease Control and Prevention. MMWR Recomm Rep. 1998 Apr 17;47(RR-4):1-43.
Iwamoto M, Wenning LA, Petry AS, Laethem M, De Smet M, Kost JT, Breidinger SA, Mangin EC, Azrolan N, Greenberg HE, Haazen W, Stone JA, Gottesdiener KM, Wagner JA. Minimal effects of ritonavir and efavirenz on the pharmacokinetics of raltegravir. Antimicrob Agents Chemother. 2008 Dec;52(12):4338-43. doi: 10.1128/AAC.01543-07. Epub 2008 Oct 6.
Blood samples
Jennifer R. King, PharmD
University of Alabama at Birmingham
Ram Yogev, MD
Northwestern University
168 participants (actual enrollment reported by the registry).
First Submitted
September 15, 2009
First Posted
September 16, 2009
Study Start
August 2002
Date type not reportedThis date has not been verified as actual or estimated.
Using Drug Levels in the Blood to Guide Therapy in HIV Infected Patients Taking a Protease Inhibitor
Participants will receive a medication regimen including MVC + LPV + RTV.
Participants will receive a medication regimen including MVC + RAL + ETV.
Participants will receive a medication regimen of DRV
Participants will receive a medication regimen of DRV
Participants will receive a medication regimen of unboosted ATV
Participants will receive a medication regimen of RPV
Participants will receive a medication regimen of RPV
100 mg daily, dosing by weight in Group I
300 mg daily
200 mg BID
Dosing by weight
150 mg BID in groups J and K; 600 mg BID in group L
Coformulation of 400 mg lopinavir and 100 mg ritonavir, taken twice daily
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Harbor Univeristy of California, Los Angeles (UCLA) Medical Center (603)
Torrance, California, 90509, United States
Childrens Hospital (U. Colorado, Denver) NICHD CRS (5052)
Denver, Colorado, 80218-1088, United States
Children's National Medical Center (5015)
Washington D.C., District of Columbia, 20010, United States
South Florida CDC Ft Lauderdale NICHD CRS (5055)
Fort Lauderdale, Florida, 33316, United States
University of Miami Pediatric Perinatal HIV/AIDS CRS (4201)
Miami, Florida, 33136, United States
University of South Florida Tampa (5018)
Tampa, Florida, 33620, United States
Rush University Cook County (5083)
Chicago, Illinois, 60612, United States
Chicago Children's CRS (4001)
Chicago, Illinois, 60614, United States
University of Maryland NICHD CRS (5094)
Baltimore, Maryland, 21201, United States
Johns Hopkins University NICHD CRS (5092)
Baltimore, Maryland, 21287, United States
Children's Hospital of Boston NICHD CRS (5009)
Boston, Massachusetts, 02115, United States
Boston Medical Center Ped. HIV Program NICHD CRS (5011)
Boston, Massachusetts, 02118, United States
WNE Maternal Pediatric Adolescent AIDS CRS (7301)
Worcester, Massachusetts, 01605, United States
New Jersey Medical School (NJ) (2802)
Newark, New Jersey, 07103, United States
New York University NY (5012)
New York, New York, 10016, United States
Metropolitan Hospital (5003)
New York, New York, 10029, United States
Columbia IMPAACT CRS (4101)
New York, New York, 10032, United States
SUNY Stony Brook NICHD CRS (5040)
Stony Brook, New York, 11794, United States
Bronx-Lebanon Hospital (6901)
The Bronx, New York, 10457, United States
Jacobi Medical Center Bronx (5013)
The Bronx, New York, 10461, United States
Duke University Medical Center (DUMC) (4701)
Durham, North Carolina, 27710, United States
The Children's Hosp. of Philadelphia IMPAACT CRS (6701)
Philadelphia, Pennsylvania, 19104, United States
St. Jude/UTHSC CRS (6501)
Memphis, Tennessee, 38105, United States
Texas Children's Hosp. CRS (3801)
Houston, Texas, 77030, United States
Harborview Medical Center NICHD CRS (5027)
Seattle, Washington, 98105, United States
Univ of Washington Children's Hospital Seattle (5017)
Seattle, Washington, 98105, United States
University of Washington NICHD CRS (5029)
Seattle, Washington, 98105, United States
San Juan City Hosp. PR NICHD CRS (5031)
San Juan, 00927, Puerto Rico
University of Puerto Rico Pediatric HIV/AIDS Research (6601)
San Juan, 00936-5067, Puerto Rico
Wenning LA, Friedman EJ, Kost JT, Breidinger SA, Stek JE, Lasseter KC, Gottesdiener KM, Chen J, Teppler H, Wagner JA, Stone JA, Iwamoto M. Lack of a significant drug interaction between raltegravir and tenofovir. Antimicrob Agents Chemother. 2008 Sep;52(9):3253-8. doi: 10.1128/AAC.00005-08. Epub 2008 Jul 14.
Cressey TR, Hazra R, Wiznia A, Foca M, Jean-Philippe P, Graham B, King JR, Britto P, Carey VJ, Acosta EP, Yogev R; IMPAACT P1058A Team. Pharmacokinetics of Unboosted Atazanavir in Treatment-experienced HIV-infected Children, Adolescents and Young Adults. Pediatr Infect Dis J. 2016 Dec;35(12):1333-1335. doi: 10.1097/INF.0000000000001320.
Primary Completion
March 2014
Actual (reported)Study Completion
March 2014
Actual (reported)Last Updated
August 7, 2015
Record last verified: 2015-08
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Source: ClinicalTrials.gov.
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