The 48-week PACTG 1020A study results confirmed that dosing ATV capsules, administered with RTV in naive and experienced patients, was generally safe and efficacious.
6) CROI 2007 abstract #715: "The PACTG 1020A Protocol: Atazanavir with or without Ritonavir in HIV-infected Infants, Children, and Adolescents.
A 2008 analysis of 1236 children and adolescents enrolled in PACTG 219/219C calculated a 76% lower risk of death in the 866 who began an NNRTI-based or a PI-based triple combination rather than some other regimen through 10 years of follow-up (HR 0.
All these youngsters were infected perinatally, and none had taken antiretrovirals before entering the PACTG studies.
Finally, a study of children enrolled in PACTG protocols 219 and 219C--a multisite US cohort of children born to HIV-positive women set up to study the long term effects of in utero antiretroviral exposure--recently reported a higher prevalence of birth defects than found in other paediatric cohorts.
Children were eligible if their mothers were enrolled in a PACTG trial in pregnancy.
But in general the poor response in PACTG
381 and COHERE can be attributed mainly to poor adherence.
Kapogiannis: In PACTG
381, adherence was the most central factor in virologic failure.
RTV- mg/d: study boosting P1020A achieves demons- higher trated [C.
Infants were pre-screened by lay counsellors and nurses for eligibility to enrol in PACTG
of the Children's Hospital of Philadelphia, said, "Timely collaboration between PACTG
investigators and pharmaceutical companies made it possible for efavirenz to be approved for HIV-infected children at the same time that it was approved for adults.
Based on these data, the PACTG
closed the treatment arm