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

Completed

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00977756

Run by

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

People needed

168

Starts

2002-08-01

Expected to finish

2014-03-01

Last updated by the study team

2015-08-07

Who can join

Age: 6 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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