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P1060 / NNRTI-Based vs. PI-Based ART in Infants Exposed/Not Exposed to NVP for PMTCT

Phase II, Parallel, Randomized Clinical Trials Comparing the Responses to Initiation of NNRTI-Based Versus PI-Based Antiretroviral Therapy in HIV-Infected Infants Who Have and Have Not Previously Received Single-Dose Nevirapine for Prevention of Mother-to-Child HIV Transmission

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P1060 is currently at protocol Version 5.0, which is an extension phase of P1060 Version 4.0.  P1060 Version 4.0 was a Phase II, randomized, controlled trial of two parallel study cohorts to compare rates of treatment failure at 24 weeks in subjects receiving a NVP-based HAART regimen versus a LPV/r-based HAART regimen, among HIV-infected infants and children ≥ 2 months to < 36 months of age who were eligible for ART.  P1060 Version 5.0 is designed to assess relative long term safety and tolerability, compare long term changes in immunologic outcomes and growth, and to compare long term rates of virologic failure.

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