A Phase 2/3, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1

Conditions

HIV-1 Infection

Brief summary

Steady-state PK parameters (Cmax, AUCtau, and Ctau) of BIC and LEN, Proportion of participants experiencing treatment-emergent AEs through Week 24, Proportion of participants experiencing treatment-emergent laboratory abnormalities through Week 24

Detailed description

Steady-state PK parameters (AUClast, Ctrough, Tmax, Tlast, t1/2, CL, Vz, and λz) for BIC and LEN, Proportion of participants experiencing treatment-emergent AEs through Week 48, Proportion of participants experiencing treatment-emergent laboratory abnormalities through Week 48, Proportion of participants with plasma HIV-1 RNA < 50 copies/mL and ≥ 50 copies/mL at Weeks 24 and 48 based on the US Food and Drug Administration (FDA)-defined snapshot algorithm, Change from baseline in CD4 cell counts and percentages at Weeks 24 and 48, Acceptability and palatability summary of LEN oral loading dose at Day 1 and Day 2 assessed by questionnaire, Acceptability and palatability summary of oral BIC/LEN oral FDC at Day 1, Week 4, Week 24, and Week 48 assessed by questionnaire

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGBICTEGRAVIR 75 MG/LENACAPAVIR 50 MG FDC TABLETS

DRUGSunlenca 300 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Steady-state PK parameters (Cmax, AUCtau, and Ctau) of BIC and LEN, Proportion of participants experiencing treatment-emergent AEs through Week 24, Proportion of participants experiencing treatment-emergent laboratory abnormalities through Week 24	—

Secondary

Measure	Time frame
Steady-state PK parameters (AUClast, Ctrough, Tmax, Tlast, t1/2, CL, Vz, and λz) for BIC and LEN, Proportion of participants experiencing treatment-emergent AEs through Week 48, Proportion of participants experiencing treatment-emergent laboratory abnormalities through Week 48, Proportion of participants with plasma HIV-1 RNA < 50 copies/mL and ≥ 50 copies/mL at Weeks 24 and 48 based on the US Food and Drug Administration (FDA)-defined snapshot algorithm, Change from baseline in CD4 cell counts and percentages at Weeks 24 and 48, Acceptability and palatability summary of LEN oral loading dose at Day 1 and Day 2 assessed by questionnaire, Acceptability and palatability summary of oral BIC/LEN oral FDC at Day 1, Week 4, Week 24, and Week 48 assessed by questionnaire	—

Measure

Time frame

Steady-state PK parameters (AUClast, Ctrough, Tmax, Tlast, t1/2, CL, Vz, and λz) for BIC and LEN, Proportion of participants experiencing treatment-emergent AEs through Week 48, Proportion of participants experiencing treatment-emergent laboratory abnormalities through Week 48, Proportion of participants with plasma HIV-1 RNA < 50 copies/mL and ≥ 50 copies/mL at Weeks 24 and 48 based on the US Food and Drug Administration (FDA)-defined snapshot algorithm, Change from baseline in CD4 cell counts and percentages at Weeks 24 and 48, Acceptability and palatability summary of LEN oral loading dose at Day 1 and Day 2 assessed by questionnaire, Acceptability and palatability summary of oral BIC/LEN oral FDC at Day 1, Week 4, Week 24, and Week 48 assessed by questionnaire

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Countries

Italy, Spain

Outcome results

None listed