IMPAACT Study P1060

P1060 (10166): 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

Study Status	Study Restriction
Participants Off Study and Primary Analysis Completed	Non-US

What is P1060?

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.

Study documents:

Sites where the study is implemented:

CRS ID	Site Name	City	Country
31441	BJ Medical College CRS	Pune, Maharashtra	India
12001	University of North Carolina Lilongwe CRS	Lilongwe	Malawi
8051	Wits RHI Shandukani Research Centre CRS	Johannesburg	South Africa
8052	Soweto IMPAACT CRS	Johannesburg	South Africa
8950	Family Clinical Research Unit (FAM-CRU) CRS	Cape Town	South Africa
5118	Kilimanjaro Christian Medical CRS	Moshi	Tanzania
30293	Makerere University - Johns Hopkins University (MU-JHU CARE LTD) Research Collaboration CRS	Kampala	Uganda
30273	George Clinic CRS	Lusaka	Zambia
31890	Harare Family Care CRS	Harare	Zimbabwe