P1104s (DAIDS ID 11878): A Longitudinal Developmental and Neuropsychological Assessment of the P1060 Clinical Trial Cohorts and Perinatally HIV-Exposed but Uninfected Controls

Study Status Study Restriction

Closed to Follow Up

Non-US

What is P1104s?

P1104s is an observational, longitudinal cohort study of HIV-infected children and HIV-uninfected controls (both perinatally-exposed to HIV and non-exposed).  The study is designed to assess the feasibility, reliability, and validity of administering a neuropsychological assessment battery and to compare neuropsychological outcomes between the study groups cross-sectionally and longitudinally over 3 years.

Study Documents:

P1104s V1 with CM 1 and LoA 1 – 4 Dec 2015

P1104s Protocol Chair Update – July 2015

Sites where the study is implemented:

CRS ID Site Name City Country

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

30293

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

Kampala

Uganda

31890

Harare Family Care CRS

Harare

Zimbabwe

Study contacts:

Study Chair: Michael Boivin

DAIDS Medical Officer: Patrick Jean-Philippe

NICHD Medical Officer: Sonia Lee

NIMH Medical Officer: Pim Brouwers

Clinical Trials Specialist: Katie McCarthy

DAIDS Clinical Representative: Judi Miller

Data Manager: Bonnie Zimmer

Field Representative: Joan Coetzee

Investigator: Mark Cotton

Investigator: Barbara Laughton

Investigator: Paul Palumbo

Investigator: Avy Violari

Laboratory Data Manager (LDM): Kaitley Wozer

Statistician: Miriam Chernoff

 

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.