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. This is an international, multicenter Phase II/III, randomized, open label, and factorial (2x2) trial. The study will enroll 256 HIV-1 (AIDS) infected children, greater than 30 days and less than 18 years of age, who are antiretroviral naive or who have received less than 56 days of antiretroviral drugs used on consecutive days after birth to prevent mother-to-infant transmission, and/or no more than two doses of nevirapine. Approximately 50% of the children will be from PACTG sites and 50% from PENTA sites.
The specific aims are to compare the combination of 2 NRTIs plus a protease inhibitor (PI) versus 2 NRTIs plus a non-nucleoside reverse transcriptase inhibitor (NNRTI) as initial therapy, followed by second-line therapy if failure occurs, in terms of their effects on a long-term virologic endpoint and to compare two different viral load criteria for switching from first-line to second-line therapy. Children will be followed for a minimum of four years (208 weeks) after enrollment of the last patient.
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