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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

November 12, 2014

Primary Completion Date

November 27, 2019

Study Completion Date

November 27, 2019

Conditions
HIV InfectionsTuberculosis
Interventions
DRUG

Raltegravir

Chewable raltegravir tablets, initially dosed at 12 mg/kg (up to a maximum of 800 mg) orally twice daily.

Trial Locations (4)

1862

Soweto IMPAACT CRS, Johannesburg

2001

Wits RHI Shandukani Research Centre CRS, Johannesburg

7505

Desmond Tutu TB Centre - Stellenbosch University (DTTC-SU) CRS, Cape Town

Famcru Crs, Cape Town

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT01751568 - Safety, Tolerance and Pharmacokinetics of Raltegravir-Containing Antiretroviral Therapy in Infants, Children Infected With HIV and TB | Biotech Hunter | Biotech Hunter