P1101: Phase I/II Dose-Finding, Safety, Tolerance, and Pharmacokinetics Study of a Raltegravir-Containing Antiretroviral Therapy (ART) Regimen in HIV-Infected and TB Co-Infected Children

Study Status Study Restriction

Enrolling

Non-US

What is P1101?

P1101 is Phase I/II, dose-finding, safety, tolerability, drug-drug interaction and pharmacokinetics study of Raltegravir (RAL) in TB co-infected children (≥ 4 weeks to < 12 years of age) taking Rifampicin (RIF)-based tuberculosis (TB) therapy. The study objectives are to determine the pharmacokinetics and appropriate dose of RAL and to determine safety and tolerance of RAL-containing ART when administered with a RIF-containing anti-TB therapy in HIV/TB co-infected children.

Study Documents:

Study Training:

Sites where the study is implemented:

CRS ID Site Name City Country

8051

Shandukani Research CRS

Johannesburg

South Africa

8052

Soweto IMPAACT CRS

Johannesburg

South Africa

8950

Stellenbosch University

Cape Town

South Africa

31790

Desmond Tutu TB Centre - Stellenbosch University (SU) CRS

Cape Town

South Africa

Study contacts:

Study Co-Chair: Paul Krogstad

Study Co-Chair: Tammy Meyers

DAIDS Medical Officer: Ellen Townley

NICHD Medical Officer: Jack Moye

Clinical Trials Specialist: Sarah Bradford

Clinical Trials Specialist: Kathleen George

Data Manager: Kayla Denson

Data Manager: Linda Marillo

Drug Co. Representative: Hedy Teppler

Immunologist: Savita Pahwa

Investigator: Andrew Wiznia

Laboratory Data Manager (LDM): Laura Hovind

Laboratory Specialist: Carolyn Yanavich

Laboratory Technologist: Paul Harding

Pharmacologist: Edward Acosta

Protocol Pharmacist: Thucuma Sise

Statistician: Pearl Samson

Virologist: Grace Aldrovandi

Virologist: Julie Nelson

 

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.