A multi-centre study to evaluate the drug level of two different HIV drugs in the plasma of children and adolescents and to compare these results to the therapeutic outcome taking the viral resistance profile into account.

A multi-centre, non-controlled, non-randomised IST to evaluate the plasma level of antiretroviral substances, the viral resistance profile and their impact on the clinical response in HIV infected children.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021624-99-DE

Enrollment

Registered

2012-04-12

Start date

2012-06-14

Completion date

Unknown

Last updated

2022-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paediatric patients with diagnosed HIV1-infection aged 2 to 17 years

Interventions

Trade Name: Kaletra (80mg + 20mg)/ ml Pharmaceutical Form: Oral solution INN or Proposed INN: LOPINAVIR CAS Number: 192725-17-0 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: eq

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.HIV1-infection under antiretroviral therapy with Darunavir/r or Lopinavir/r under dosage referring to summary of product characteristics and two NRTI´s for >2 weeks. 2. Girl or boy between 2 and 17 years of age. 3. Existing test of genotypic resistances before the start or change of therapy 4.pharmacokinetic evaluation during ART therapy or at Visit 1 5.Informed consent and assent 6. Participation in the paediatric cohort of the Kompetenznetz HIV/ AIDS or in a simiiar cohort and - for the retrospective part of the study - the availability of the fully documented (retrospective) data. 7.Ability to take party in this study and to adhere to the protocoll Are the trial subjects under 18? yes Number of subjects for this age range: 48 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Non-adherence 2. Active AIDS-defining disease 3. Therapy with Nevirapine, Efavirenz, Etravirin, Tipravir, Fosamprenavir or other drugs, which affect the drug levels. 4.Vomiting or diarrhoea > Grade 1 DAIDS Grading Scale 2004 (see appendix 1) 5. Existence or occurrence of contra-indications, according to summary of product characteristics Kaletra® or Prezista® (possible study participants at baseline are already treated with Kaletra® or Prezista® (plus Norvir®) with appropriate control of the contra-indications, which are re-evaluated at baseline). Kaletra®: Hypersensitivity to Lopinavir, Ritonavir or other ingredients of the medication, liver function disorders, ingestion of substances which are metabolised via P450 isoenzyme CYP 3A4 or CYP2D6, intake of Rifampicin or St. John´s wort. Prezista®: Hypersensitivity to Darunavir, Ritonavir or other ingredients of the medication, liver function disorders, ingestion of substances which are metabolised via P450 isoenzyme CYP 3A4, intake of Rifampicin or St. John´s wort. Norvir®: Hypersensitivity to Lopinavir, Ritonavir or other ingredients of the medication, intake of substances which are metabolised via P450 isoenzyme CYP 3A4, ntake of St. John´s wort. 6. A positive pregnancy test in females of childbearing age 7.In sexually active adolescents: a lack of willingness to use a barrier method (condom) in combination with another contraceptive method. 8. Condition, that would exclude the participation in the opinion of the investigator

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary endpoint is the number of children with virological failure during the study, wherein failure is defined as either two consecutive viral loads >1000 copies/ml or absence of reduction of viral load at the beginning of treatment and correlation to pharmacologic parameters and genotypic resistance.;Secondary Objective: Secondary endpoints are the development of CD4-cellcounts, the occurrence of side effects and the initial response to therapy (reduction of viral load and increase of CD4-cells) taking into account the pharmacological parameters and the genotypic resistance.;Primary end point(s): Primary endpoint is the number of children with virological failure during the study, wherein failure is defined as either two consecutive viral loads >1000 copies/ml or absence of reduction of viral load at the beginning of treatment and correlation to pharmacologic parameters and genotypic resistance.;Timepoint(s) of evaluation of this end point: retorspectiv Screening week 4 (PK) month 3 month 6 month 9 month 12 month 15 month 18 month 21 month 24 month 27 month 30 month =33 (PK) = V12 month V12 + 3 Monate	—

Measure

Time frame

Main Objective: Primary endpoint is the number of children with virological failure during the study, wherein failure is defined as either two consecutive viral loads >1000 copies/ml or absence of reduction of viral load at the beginning of treatment and correlation to pharmacologic parameters and genotypic resistance.;Secondary Objective: Secondary endpoints are the development of CD4-cellcounts, the occurrence of side effects and the initial response to therapy (reduction of viral load and increase of CD4-cells) taking into account the pharmacological parameters and the genotypic resistance.;Primary end point(s): Primary endpoint is the number of children with virological failure during the study, wherein failure is defined as either two consecutive viral loads >1000 copies/ml or absence of reduction of viral load at the beginning of treatment and correlation to pharmacologic parameters and genotypic resistance.;Timepoint(s) of evaluation of this end point: retorspectiv Screening week 4 (PK) month 3 month 6 month 9 month 12 month 15 month 18 month 21 month 24 month 27 month 30 month =33 (PK) = V12 month V12 + 3 Monate

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints are the development of CD4-cellcounts, the occurrence of side effects and the initial response to therapy (reduction of viral load and increase of CD4-cells) taking into account the pharmacological parameters and the genotypic resistance. ;Timepoint(s) of evaluation of this end point: retorspectiv Screening week 4 (PK) month 3 month 6 month 9 month 12 month 15 month 18 month 21 month 24 month 27 month 30 month =33 (PK) = V12 month V12 + 3 Monate	—

Measure

Time frame

Secondary end point(s): Secondary endpoints are the development of CD4-cellcounts, the occurrence of side effects and the initial response to therapy (reduction of viral load and increase of CD4-cells) taking into account the pharmacological parameters and the genotypic resistance. ;Timepoint(s) of evaluation of this end point: retorspectiv Screening week 4 (PK) month 3 month 6 month 9 month 12 month 15 month 18 month 21 month 24 month 27 month 30 month =33 (PK) = V12 month V12 + 3 Monate

—

Countries

Germany

Contacts

Public ContactDr. Dr. Christoph Königs

University Hospital of goethe university

christoph.koenigs@kgu.de004969630183030

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026