Preliminary results from first paediatric raltegravir study

HIV Treat Bull - 2009 May-Jun;10(5/6): 21

Polly Clayden, HIV i-Base

Adrew Wiznia and coworkers from IMPAACT P1066 showed preliminary results from the first paediatric study of raltegravir (RAL).

This is an ongoing prospective, non-randomised, open label, dose-finding trial of RAL plus optimised background regimen (OBR) in treatment-experienced children.

Children aged >12 to <19 years (cohort 1) and >6 to to <12 years (cohort IIA). The children are enrolled sequentially older to younger.

Children in stage I received RAL poloxamer film tablets that were added to a stable, failing ART regimen. Pharmacokinetics (PK) was done on day 7 to 12 and then OBR started.

The study had enrolled 36 patients (22 in cohort I and 14 in cohort IIA. They initially received a 6 or 8mg/kg dose bid with a maximum dose of 600mg bid.

The study demographics included: 47% male, 67% black, and 25% white. Median baseline viral load was 4.4 log (range 3.1 to 5.9) copies/mL and were similar between the cohorts. Median CD4 percentage was 22 (range 0 to 42%).

Six children had grade 3/4 adverse events: 5 had neutropenia, 1 increased lipids, and 1 increased creatinine associated with aminoglycoside use. One grade 4 neutropenia and one elevated GGT was possibly associated with RAL.

There were no deaths. Four children were withdrawn from the study, 3 because of poor adherence (cohort 1) and one at the request of the doctor (cohort IIA).

In an intent-to-treat analysis of those treated at 8 mg/kg 23/30 (77%) and 24 of 14/30 (86%) were <400 copies/mL (50% and 63% <50 copies/mL) at weeks 8 and 12 respectively. Median CD4 percentage was 24% at both timepoints.

The investigators wrote: “Preliminary, short-term and partial data from IMPAACT P1066 suggests that RAL + OBR in children ages 6 to 18 was generally safe, well tolerated and effective. Enrollment into these cohorts, as well as use of a chewable formulation for children <12 years of age, is continuing”.

Comment

For cohort IIA, repeat PK and safety evaluations at a uniform dose of 400 mg bid regardless of weight is ongoing.

Merck will continue this paediatric programme with sequential age strata down to 4 weeks of age.

In addition to the chewable formulation, oral granules for suspension are planned for children less than two years old.

Ref: Wiznia A et al. Safety and efficacy of raltegravir in pediatric HIV infection. Preliminary analysis from the International Maternal Pediatric Adolescent AIDS Clinical Trials group, P1066. Conf Retroviruses Opportunistic Infect 2009 Feb 8-11;16: Poster abstract 874.

2009-05-10
IB2009-05-21

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