Safety, Tolerance and Pharmacokinetics of Raltegravir-Containing Antiretroviral Therapy in Infants, Children Infected With HIV and TB

Summary

People who are infected with HIV and tuberculosis (TB) need to receive medications that treat both diseases safely and effectively. This study enrolled infants and children infected with HIV and TB and evaluated the safety and tolerance of an antiretroviral (ARV) treatment regimen for HIV that contains raltegravir when administered with a TB treatment regimen that includes rifampicin. Study researchers aimed to determine the most effective dose of raltegravir for infants and children when taken with rifampicin.

Timeline

Start

2014-11-12

Primary completion

2019-11-27

Completion

2019-11-27

Publications

• Background Lawn SD, Myer L, Bekker LG, Wood R. Burden of tuberculosis in an antiretroviral treatment programme in sub-Saharan Africa: impact on treatment outcomes and implications for tuberculosis control. AIDS. 2006 Aug 1;20(12):1605-12. doi: 10.1097/01.aids.0000238406.93249.cd.
• Background Walters E, Cotton MF, Rabie H, Schaaf HS, Walters LO, Marais BJ. Clinical presentation and outcome of tuberculosis in human immunodeficiency virus infected children on anti-retroviral therapy. BMC Pediatr. 2008 Jan 11;8:1. doi: 10.1186/1471-2431-8-1.
• Krogstad P, Samson P, Acosta EP, Moye J, Townley E, Bradford S, Brown E, Denson K, Graham B, Hovind L, Sise T, Teppler H, Mathiba SR, Fairlie L, Winckler JL, Slade G, Meyers T; International Maternal Pediatric Adolescent AIDS Clinical Trials Network P1101 Team. Pharmacokinetics and Safety of a Raltegravir-Containing Regimen in Children Aged 4 Weeks to 2 Years Living With Human Immunodeficiency Virus and Receiving Rifampin for Tuberculosis. J Pediatric Infect Dis Soc. 2021 Mar 26;10(2):201-204. doi: 10.1093/jpids/piaa039.

Drugs

Indications