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 |
---|---|---|---|
BJ Medical College CRS |
Pune, Maharashtra |
India |
|
University of North Carolina Lilongwe CRS |
Lilongwe |
Malawi |
|
Wits RHI Shandukani Research Centre CRS |
Johannesburg |
South Africa |
|
Soweto IMPAACT CRS |
Johannesburg |
South Africa |
|
Family Clinical Research Unit (FAM-CRU) CRS |
Cape Town |
South Africa |
|
Kilimanjaro Christian Medical CRS |
Moshi |
Tanzania |
|
Makerere University - Johns Hopkins University (MU-JHU CARE LTD) Research Collaboration CRS |
Kampala |
Uganda |
|
George Clinic CRS |
Lusaka |
Zambia |
|
Harare Family Care CRS |
Harare |
Zimbabwe |
Study contacts:
Study Chair: Paul Palumbo |
Study Co-Chair: Moherndran Archary |
Study Co-Chair: Linda Barlow-Mosha |
Study Vice-Chair: Avy Violari |
DAIDS Medical Officer: Patrick Jean-Philippe |
NICHD Medical Officer: Rohan Hazra |
Clinical Trials Specialist: Katie McCarthy |
Data Manager: Bonnie Zimmer |
Drug Co. Representative: Navdeep Thoofer |
Field Representative: Emily Barr |
Field Representative: Joan Coetzee |
Investigator: Elaine Abrams |
Investigator: Robert Bollinger |
Investigator: Mutsawashe Bwakura-Dangarembizi |
Investigator: Benjamin Chi |
Investigator: Mark Cotton |
Investigator: Portia Kamthunzi |
Investigator: Philippa Musoke |
Investigator: Werner Schimana |
Laboratory Data Manager (LDM): Mark Lojacono |
Protocol Pharmacist: Lynette Purdue |
Statistician: Jane Lindsey |