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.

NCT00977756

Conditions

1. HIV Infections

Interventions

1. Drug: Raltegravir (RAL)
2. Drug: Atazanavir (ATV)
3. Drug: Ritonavir (RTV)
4. Drug: Tenofovir (TDF)
5. Drug: Etravirine (ETV)
6. Drug: Darunavir (DRV)
7. Drug: Maraviroc (MVC)
8. Drug: Lopinavir/ritonavir (LPV/r)

MeSH:HIV Infections

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

IMPAACT P1058A: Pharmacokinetic Effects of New Antiretroviral Drugs on Children, Adolescents and Young Adults This study will examine drug and body interactions in children receiving anti-HIV treatment regimens using new medications. --- P1058A ---

- 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. --- P1058A ---

- 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 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. --- P1058A ---

- 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 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. --- P1058A --- --- P1058A ---

- 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 HIV Infections HIV Infections Antiretroviral (ARV) medication regimens for children, adolescents and young adults are often prescribed based on drug resistance because of previous treatment history. --- P1058A ---

- 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 HIV Infections HIV Infections Antiretroviral (ARV) medication regimens for children, adolescents and young adults are often prescribed based on drug resistance because of previous treatment history. --- P1058A --- --- P1058A ---