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.

• Register: EUCTR
• Last refreshed on: 23 May 2022
• Main ID: EUCTR2010-021624-99-DE
• Date of registration: 12/04/2012
• Prospective Registration: Yes
• Primary sponsor: Decan of Medical Faculty of Goethe University Frankfurt
• Public title: 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.
• Scientific title: 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.
• Date of first enrolment: 14/06/2012
• Target sample size: 48
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-021624-99
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Germany

Contacts

• Name: Dr. Dr. Christoph Königs
• Affiliation: University Hospital of goethe university

• Name: Dr. Dr. Christoph Königs
• Affiliation: University Hospital of goethe university

Key inclusion & exclusion 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:
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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Intervention(s)

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: equal
Concentration number: 80-
INN or Proposed INN: RITONAVIR
CAS Number: 155213-67-5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Trade Name: Kaletra 100 mg/25 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: LOPINAVIR
CAS Number: 192725-17-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: RITONAVIR
CAS Number: 155213-67-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Trade Name: Kaletra 200 mg/50 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: LOPINAVIR
CAS Number: 192725-17-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
INN or Proposed INN: RITONAVIR
CAS Number: 155213-67-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Trade Name: Norvir 100 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RITONAVIR
CAS Number: 155213-67-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Trade Name: Norvir 80 mg/ml
Pharmaceutical Form: Oral solution
INN or Proposed INN: RITONAVIR
CAS Number: 155213-67-5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 80-

Trade Name: PREZISTA 75 mg filmcoated tablets
Product Name: Prezista 75mg filmcoated tablet
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: DARUNAVIR
CAS Number: 206361-99-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentr

Primary Outcome(s)

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.

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

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.

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.

Secondary Outcome(s)

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

Secondary ID(s)

HIV-TDM-GTKids

Source(s) of Monetary Support

Hector foundation

Ethic committee, university hospital goethe university

Ethics review

Status: Approved
Approval date: 14/06/2012
Contact: