PACTG P1026S: PHARMACOKINETIC PROPERTIES OF ANTIRETROVIRAL DRUG DURING PREGNANCY

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. DESIGN: Prospective pharmacokinetic substudy for subjects enrolled in PACTG P1025 SAMPLE SIZE: The sample size will be 25 subjects per drug/drug combination or a total of 125 subjects. POPULATION: Subjects can enroll at = 20 weeks gestation. Subjects must be enrolled in P1025 and currently receiving one of the following antiretroviral drugs or interacting combinations at adult dosing: " abacavir (300 mg b.i.d.) " lopinavir/ritonavir (Kaletra¿) (400/100 mg b.i.d. until 30 weeks gestation, then 533/133 mg b.i.d. until results of postpartum PK evaluation are available) " fosamprenavir/ritonavir (700/100 mg b.i.d.) " atazanavir/ritonavir (300/100 mg q.d.) " ddI delayed release (Videx¿ EC) (400 mg q.d. if weight > 60 kg; 250 mg q.d. if weight < 60 kg) " emtricitabine (200 mg q.d.) " tenofovir (300 mg q.d.) " tenofovir/atazanavir/ritonavir (300/300/100 mg q.d.) REGIMEN: Pregnant women will continue on antiretroviral medications prescribed by their clinicians. Pharmacokinetic evaluations: Antepartum: peripheral blood specimen during third trimester (30-36 weeks); time of sampling will vary by antiretroviral regimen. Intrapartum: maternal peripheral blood specimen at time cord is clamped and cord blood specimen. Postpartum: peripheral blood specimen at 6-12 weeks postpartum; time of sampling will vary by antiretroviral regimen. Note: If it is found that drug levels are not adequate, dose adjustments may be made. The new dose may be higher than the current FDA approved dose.