IMPAACT P1058A: Pharmacokinetic Effects of New Antiretroviral Drugs on Children, Adolescents and Young Adults
NCT ID: NCT00977756
Last Updated: 2015-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
168 participants
OBSERVATIONAL
2002-08-31
2014-03-31
Brief Summary
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Detailed Description
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Participation in this study will last between 1 and 7 weeks and involve at least two clinic visits. The first is a screening and entry visit at which a medical history will be taken and a physical exam and blood test will be completed. The second visit will measure PK of the medications. During this visit, participants will complete the same measures as before-medical history, physical exam, blood test-and then be given a dose of their anti-HIV medication regimen. After receiving the medications, participants will be monitored and give blood samples after 1, 2, 4, 6, 8, and 12 hours. For Groups G, H, I, J, K and L an intensive 12-hour PK study will be scheduled after at least 30 days on the combination of interest. For all Groups, the intensive 12-hour PK study should be performed within 35 days (5 weeks) of screening/entry evaluations. Medications will not be provided through this study.
Results of the 12-hour medication monitoring tests will be delivered to participants' physicians within 6 weeks. If, based on these results, a physician decides to change the dosage of a participant's medication, that participant may be asked to complete a second PK visit. Participants must have received the revised dose for at least 14 days before the PK study can be repeated.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group G
Participants will receive a medication regimen including RAL + ATV + RTV.
Raltegravir (RAL)
400 mg twice daily (BID)
Atazanavir (ATV)
300 mg daily
Ritonavir (RTV)
100 mg daily, dosing by weight in Group I
Group H
Participants will receive a medication regimen including RAL + TDF.
Raltegravir (RAL)
400 mg twice daily (BID)
Tenofovir (TDF)
300 mg daily
Group I
Participants will receive a medication regimen including ETV + DRV + RTV.
Ritonavir (RTV)
100 mg daily, dosing by weight in Group I
Etravirine (ETV)
200 mg BID
Darunavir (DRV)
Dosing by weight
Group J
Participants will receive a medication regimen including MVC + ATV + RTV.
Atazanavir (ATV)
300 mg daily
Ritonavir (RTV)
100 mg daily, dosing by weight in Group I
Maraviroc (MVC)
150 mg BID in groups J and K; 600 mg BID in group L
Group K
Participants will receive a medication regimen including MVC + LPV + RTV.
Ritonavir (RTV)
100 mg daily, dosing by weight in Group I
Maraviroc (MVC)
150 mg BID in groups J and K; 600 mg BID in group L
Lopinavir/ritonavir (LPV/r)
Coformulation of 400 mg lopinavir and 100 mg ritonavir, taken twice daily
Group L
Participants will receive a medication regimen including MVC + RAL + ETV.
Raltegravir (RAL)
400 mg twice daily (BID)
Etravirine (ETV)
200 mg BID
Maraviroc (MVC)
150 mg BID in groups J and K; 600 mg BID in group L
Arm M
Participants will receive a medication regimen of DRV
No interventions assigned to this group
Arm N
Participants will receive a medication regimen of DRV
No interventions assigned to this group
Arm O
Participants will receive a medication regimen of unboosted ATV
No interventions assigned to this group
Arm P
Participants will receive a medication regimen of RPV
No interventions assigned to this group
Arm Q
Participants will receive a medication regimen of RPV
No interventions assigned to this group
Interventions
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Raltegravir (RAL)
400 mg twice daily (BID)
Atazanavir (ATV)
300 mg daily
Ritonavir (RTV)
100 mg daily, dosing by weight in Group I
Tenofovir (TDF)
300 mg daily
Etravirine (ETV)
200 mg BID
Darunavir (DRV)
Dosing by weight
Maraviroc (MVC)
150 mg BID in groups J and K; 600 mg BID in group L
Lopinavir/ritonavir (LPV/r)
Coformulation of 400 mg lopinavir and 100 mg ritonavir, taken twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HIV infected
* Stable on the specified antiretroviral (ARV) regimen for 30 days prior to screening and entry. ARVs will not be provided through this protocol.
* Prescribed one of the regimens described in the study details by clinician on the basis of clinical need (although the availability of drug levels may have been a factor in clinical decision-making). The decision to initiate the regimen must have been solely that of the prescribing physician.
* On the ARV combination of interest for at least 14 days and within 5 weeks (35 days) of the date of screening results
* Body surface area (BSA) of at least 0.85 m2
* Participants in P1058 Version 1.0 and Version 2.0 who have switched to a regimen specified in the entry criteria are eligible for P1058A.
* Any licensed formulation that achieves these dosages, but without including a disallowed drug, may be used.
* Participants who have enrolled in P1058A (Groups G-L) and who subsequently switch to a different regimen specified in the entry criteria are eligible to re-register to a subsequent step of P1058A (re-consent required)
* Females must agree to use two reliable methods of contraception, one of which must be a barrier method, while taking study medications and for 6 weeks after study testing
* Documentation of presence of an R5-tropic virus at the start of treatment with maraviroc (MVC)
Exclusion Criteria
* Hemoglobin level less than 8.5 g/dL
* Clinical evidence of pancreatitis as defined by moderate clinical symptoms
* Treatment with any anti-HIV or non-ARV drug that could interact with drugs under pharmacokinetic (PK) study in the 14 days prior to study entry
* Known allergy, sensitivity, or hypersensitivity to components of two or more study-specified drugs or their formulation
6 Years
21 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
NETWORK
Responsible Party
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Principal Investigators
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Jennifer R. King, PharmD
Role: STUDY_CHAIR
University of Alabama at Birmingham
Ram Yogev, MD
Role: STUDY_CHAIR
Northwestern University Feinberg School of Medicine
Locations
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Univ. of Alabama Birmingham NICHD CRS (5096)
Birmingham, Alabama, United States
Miller Children's Hospital Long Beach, CA NICHD CRS (5093)
Long Beach, California, United States
Usc La Nichd Crs (5048)
Los Angeles, California, United States
UCSD Mother, Child & Adolescent HIV Program(4601)
San Diego, California, United States
Univ. of California San Francisco NICHD CRS (5091)
San Francisco, California, United States
Harbor (UCLA) Medical Center NICHD CRS (5045)
Torrance, California, United States
Harbor Univeristy of California, Los Angeles (UCLA) Medical Center (603)
Torrance, California, United States
Childrens Hospital (U. Colorado, Denver) NICHD CRS (5052)
Denver, Colorado, United States
Children's National Medical Center (5015)
Washington D.C., District of Columbia, United States
South Florida CDC Ft Lauderdale NICHD CRS (5055)
Fort Lauderdale, Florida, United States
University of Miami Pediatric Perinatal HIV/AIDS CRS (4201)
Miami, Florida, United States
University of South Florida Tampa (5018)
Tampa, Florida, United States
Rush University Cook County (5083)
Chicago, Illinois, United States
Chicago Children's CRS (4001)
Chicago, Illinois, United States
University of Maryland NICHD CRS (5094)
Baltimore, Maryland, United States
Johns Hopkins University NICHD CRS (5092)
Baltimore, Maryland, United States
Children's Hospital of Boston NICHD CRS (5009)
Boston, Massachusetts, United States
Boston Medical Center Ped. HIV Program NICHD CRS (5011)
Boston, Massachusetts, United States
WNE Maternal Pediatric Adolescent AIDS CRS (7301)
Worcester, Massachusetts, United States
New Jersey Medical School (NJ) (2802)
Newark, New Jersey, United States
New York University NY (5012)
New York, New York, United States
Metropolitan Hospital (5003)
New York, New York, United States
Columbia IMPAACT CRS (4101)
New York, New York, United States
SUNY Stony Brook NICHD CRS (5040)
Stony Brook, New York, United States
Bronx-Lebanon Hospital (6901)
The Bronx, New York, United States
Jacobi Medical Center Bronx (5013)
The Bronx, New York, United States
Duke University Medical Center (DUMC) (4701)
Durham, North Carolina, United States
The Children's Hosp. of Philadelphia IMPAACT CRS (6701)
Philadelphia, Pennsylvania, United States
St. Jude/UTHSC CRS (6501)
Memphis, Tennessee, United States
Texas Children's Hosp. CRS (3801)
Houston, Texas, United States
Harborview Medical Center NICHD CRS (5027)
Seattle, Washington, United States
Univ of Washington Children's Hospital Seattle (5017)
Seattle, Washington, United States
University of Washington NICHD CRS (5029)
Seattle, Washington, United States
San Juan City Hosp. PR NICHD CRS (5031)
San Juan, , Puerto Rico
University of Puerto Rico Pediatric HIV/AIDS Research (6601)
San Juan, , Puerto Rico
Countries
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References
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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.
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.
Other Identifiers
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IMPAACT P1058A
Identifier Type: -
Identifier Source: org_study_id
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