IMPAACT P1058A: Pharmacokinetic Effects of New Antiretroviral Drugs on Children, Adolescents and Young Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Observational

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.
    

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.
    

Intervention name(s): Raltegravir (RAL); Atazanavir (ATV); Ritonavir (RTV); Tenofovir (TDF); Etravirine (ETV); Darunavir (DRV); Maraviroc (MVC); Lopinavir/ritonavir (LPV/r)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 400 mg twice daily (BID); 300 mg daily; 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
Other intervention name(s): Isentress; Reyataz; Norvir; Viread; Intelence; Prezista; Selzentry; Kaletra
Intervention MeSH terms: Ritonavir; Lopinavir; Atazanavir Sulfate; Darunavir; Tenofovir; Raltegravir Potassium; Maraviroc; Etravirine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV 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.
      
Biospecimen description: 
      Blood samples
    
Keywords: Treatment; Children; Integrase Inhibitors; Entry Inhibitors; Treatment Experienced