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

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Atazanavir Sulfate; Darunavir; Etravirine; Lopinavir; Maraviroc; Raltegravir Potassium; Ritonavir; Tenofovir

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