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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

Concluded

DAIDS Number

11831

IND Number

77,787

Clinical Trials Link

Summary

P1101 is a 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 Co-Chair

DAIDS Medical Officer

NICHD Medical Officer

Clinical Research Manager

Immunologist

Investigator

Laboratory Data Manager (LDM)

Laboratory Specialist

Laboratory Technologist

Pharmacologist

Protocol Pharmacist

Abstracts

P1101: Phase I/II Study of a Raltegravir Containing Regimen in HIV-TB Cotreated Children

Conference

CROI 2018

Study

P1101

Authors

T Meyers, P Krogstad, P Samson, E Acosta, J Moye, E Townley, S Bradford, L Marillo, L Hovind, T Sise, H Teppler, S Dittmer, L Fairlie, A Hesseling, M Cotton

P1101: Phase I/II Study of Raltegravir-Containing Regimen in HIV and TB Co-Treated Children Aged 6-<12 Years

Conference

10th International Workshop on HIV Pediatrics

Study

P1101

Authors

P Krogstad, P Samson, T Meyers, E Acosta, J Moye, E Townley, S Bradford, L Marillo, K Denson, L Hovind, T Sise, H Teppler, S Dittmer, L Fairlie, A Hesseling, M Cotton

Pharmacokinetics of Raltegravir in HIV/TB Co-Treated Infants and Young Children

Conference

CROI 2020

Study

P1101

Authors

P Krogstad, P Samson, E Acosta, J Moye, E Townley, S Bradford, E Brown, B Graham, L Hovind, H Teppler, SR Mathiba, M Masebole, M Cotton, J Winckler, T Meyers

Phase I/II study of a raltegravir-containing regimen in HIV-infected children with TB

Conference

CROI 2018

Study

P1101

Authors

Meyers T