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

Information source: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Raltegravir (RAL) (Drug); Atazanavir (ATV) (Drug); Ritonavir (RTV) (Drug); Tenofovir (TDF) (Drug); Etravirine (ETV) (Drug); Darunavir (DRV) (Drug); Maraviroc (MVC) (Drug); Lopinavir/ritonavir (LPV/r) (Drug)

Phase: N/A

Status: Completed

Sponsored by: International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Official(s) and/or principal investigator(s):
Jennifer R. King, PharmD, Study Chair, Affiliation: University of Alabama at Birmingham
Ram Yogev, MD, Study Chair, Affiliation: Northwestern University Feinberg School of Medicine

Summary

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.

Clinical Details

Official title: IMPAACT P1058A: Intensive Pharmacokinetic Studies of New Classes of Antiretroviral Drug Combinations in Children, Adolescents and Young Adults

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Steady state pharmacokinetics (PK) of raltegravir administered in combination with atazanavir/ritonavir or tenofovir or maraviroc/etravirine to older children, adolescents and young adults

Steady state PK of etravirine administered to older children, adolescents and young adults

Steady state PK of maraviroc administered in combination with atazanavir/ritonavir or lopinavir/ritonavir to older children, adolescents and young adults

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

Secondary outcome:

Relationship between Tanner stage and the PK of the regimens of interest in children and adolescents

Relationships between the PK parameters and polymorphisms that may affect the antiretrovirals (ARVs) of interest in older children, adolescents and young adults

Adverse events associated with the ARVs of interest

Steady state PK of darunavir/ritonavir administered to older children, adolescents and young adults

Detailed description: Antiretroviral (ARV) medication regimens for children, adolescents and young adults are often prescribed based on drug resistance because of previous treatment history. In order to find an effective regimen, clinicians must often turn to newer drugs before they have been fully tested in adolescent or pediatric clinical trials. One of the first steps in testing these drugs is to assess the drug pharmacokinetics (PK), or interaction between drugs and body. This study, a follow-on protocol to the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) P1058 study, will test children, adolescents and young adults who have already been prescribed treatment regimens with new drugs. The study will examine the PK of medication combinations featuring raltegravir, a new drug in the new ARV class of entry inhibitors (EIs); maraviroc, a new drug in the new class of fusion inhibitors (FIs); and etravirine, a new drug in the class of non-nucleoside reverse transcriptase inhibitors (NNRTIs). Older medications may also be used to complete these regimens. 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.

Eligibility

Minimum age: 6 Years. Maximum age: 21 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Certain laboratory values received within 5 weeks of the date of the screening or

entry evaluations

- 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:

- Pregnant or breastfeeding

- 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

Locations and Contacts

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

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

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, 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

Chicago Children's CRS (4001), Chicago, Illinois 60614, United States

Rush University Cook County (5083), Chicago, Illinois 60612, United States

Johns Hopkins University NICHD CRS (5092), Baltimore, Maryland 21287, United States

University of Maryland NICHD CRS (5094), Baltimore, Maryland 21201, United States

Boston Medical Center Ped. HIV Program NICHD CRS (5011), Boston, Massachusetts 02118, United States

Children's Hospital of Boston NICHD CRS (5009), Boston, Massachusetts 02115, 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

Bronx-Lebanon Hospital (6901), Bronx, New York 10457, United States

Jacobi Medical Center Bronx (5013), Bronx, New York 10461, United States

Columbia IMPAACT CRS (4101), New York, New York 10032, United States

Metropolitan Hospital (5003), New York, New York 10029, United States

New York University NY (5012), New York, New York 10016, United States

SUNY Stony Brook NICHD CRS (5040), Stony Brook, New York 11794, 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

Additional Information

Related publications:

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. Erratum in: MMWR Morb Mortal Wkly Rep 1998 Apr 24;47(15):315.

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.

Starting date: August 2002
Last updated: August 5, 2015

Page last updated: August 23, 2015

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