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 Infants and Children

Study Status Study Restriction



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:

P1101 study training

Sites where the study is implemented:

CRS ID Site Name City Country


Wits RHI Shandukani Research Centre CRS


South Africa




South Africa


Family Clinical Research Unit (FAM-CRU) CRS

Cape Town

South Africa


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: Emily Brown

Data Manager: Kayla Denson

Data Manager: Bobbie Graham

Drug Co. Representative: Hedy Teppler

Immunologist: Savita Pahwa

Investigator: Andrew Wiznia

Laboratory Data Manager (LDM): Laura Hovind

Laboratory Specialist: Carolyn Yanavich

Laboratory Specialist: Sara Zabih

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.