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

Closed to Follow Up

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

Shandukani Research CRS

Johannesburg

South Africa

8052

Soweto IMPAACT CRS

Johannesburg

South Africa

8950

Stellenbosch University

Cape Town

South Africa

5118

Kilimanjaro Christian Medical CRS

Moshi

Tanzania

30293

Makerere University - Johns Hopkins University (MU-JHU) Research Collaboration

Kampala

Uganda

30273

George Clinic CRS

Lusaka

Zambia

31890

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): Kaitley Wozer

Protocol Pharmacist: Lynette Purdue

Statistician: Jane Lindsey

 

Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.