Condition category
Infections and Infestations
Date applied
28/02/2011
Date assigned
28/04/2011
Last edited
28/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Diana Gibb

ORCID ID

Contact details

Medical Research Council
Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Children with HIV in Africa - Pharmacokinetics and Adherence of Simple Antiretroviral Regimens (CHAPAS-2): an open, randomised, controlled, phase I, crossover trial

Acronym

CHAPAS-2

Study hypothesis

1. There is no difference in blood drug levels (overall area under the plasma concentration time curve (AUC) and Cmin) among children aged 4-13 years taking Cipla sprinkle or Cipla tablet formulations of ritonavir-boosted-lopinavir together with food and also compared to historical controls.
2. There is no difference in blood drug levels (overall area under the plasma concentration time curve (AUC) and Cmin) among infants (under 1 year) taking Abbott Kaletra® syrup or Cipla sprinkle formulations of ritonavir-boosted-lopinavir together with food according to World Health Oragnisation (WHO) doses and weightbands and also compared to historical controls.

Ethics approval

1. UCL Research Ethics Committee approved on 19th October 2009, (ref: application 1665/001)
2. Joint Clinical Research Centre IRB approved on 30th October 2009
3. Ugandan National Council of Science and Technology approved on 23rd April 2010

Study design

Open randomised controlled phase I crossover trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Human immunodeficiency virus (HIV)

Intervention

24 children (aged 4-13 years able to take paediatric LPV/r tablets and either currently receiving LPV/r or about to start LPV/r containing ART) in a (1:1) ratio to LPV/r either in sprinkle or tablet formulation with food. After 4 weeks on allocated treatment children will have a 12 hour pharmacokinetcis (PK) day with 7 blood draws (1.5-2.5ml each). Children will then switch LPV/r formulation to the other formulation (sprinkle or tablet) and continue to take that formulation with food for a further 4 weeks. At week 8, children will have a second 12 hour PK day of 7 blood draws (1.5-2.5ml each) after which children will choose which formulation of LPV/r they wish to remain on.

A third non-randomised intervention arm will include infants from 3 months to 1 year, already receiving or about to start LPV/r syrup with food. Infants will be followed for 4 weeks followed by a 12 hour PK day. They will then switch formulation to receive LPV/r sprinkle with food for 4 weeks followed by a second 12 hour PK day of 7 blood draws (1.5-2.5ml each) at week 8.

Intervention type

Other

Phase

Phase I

Drug names

Primary outcome measures

1. To determine the pharmacokinetics (PK) of ritonavir-boosted-lopinavir (LPV/r) in a twice daily paediatric co-formulated fixed dose sprinkle combination (Lopimune, Cipla pharmaceuticals) and compare it to LPV/r in a twice daily paediatric co-formulated fixed dose tablet combination (Cipla Pharmaceuticals), both with food, in HIV-infected African children aged 4-12 years
2. To determine the pharmacokinetics (PK) of ritonavir-boosted-lopinavir (LPV/r) in a twice daily paediatric co-formulated fixed dose sprinkle combination (Lopimune, Cipla pharmaceuticals) and compare it to LPV/r in a twice daily paediatric co-formulated syrup (Abbott Pharmaceuticals), both with food, in HIV-infected African infants under 1 year of age

Secondary outcome measures

1. To compare the formulation preferences of children and their carers in terms of sprinkle or tablets
2. To compare the formulation preferences of infants carers in terms of sprinkle or syrups
3. To evaluate the effects of age, sex, severity of illness and anthropometric measurements [weight-for-age, height-for-age, body mass index (BMI), middle upper arm circumference (MUAC) and malnutrition indices] on pharmacokinetic parameters for LPV/r in HIV-infected African children. Specifically, to examine whether malnutrition modifies the pharmacokinetic characteristics of boosted Protease Inhibitors (PIs).

Overall trial start date

15/04/2011

Overall trial end date

01/03/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Human immunodeficiency virus (HIV) infected infants aged 3 months to < 12 months currently taking or about to start Lopinavir/ritonavir (LPV/r) syrup based first-line following WHO guidelines 2008 [7] or
2. HIV infected children able to swallow paediatric LPV/r tablets and aged 4-13 years and < 25Kg, currently taking or about to start LPV/r based second-line following WHO guidelines
2. Carers and children where appropriate, willing and able to give informed consent

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

40

Participant exclusion criteria

Children:
1. Who are expected to change weight bands (i.e. change dose) after enrollment and before PK day at week 8
2. With anaemia (haemoglobin < 8.5g/dL) or liver enzymes grade 2 or higher
3. With illnesses that could influence the pharmacokinetics of the antiretroviral (ARV) drugs at week 4 and week 8 e.g. severe diarrhoea, vomiting, renal or liver disease
4. On concomitant medications that are known to interact with the ARV drugs

Recruitment start date

15/04/2011

Recruitment end date

01/03/2012

Locations

Countries of recruitment

Uganda

Trial participating centre

Medical Research Council
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Medical Research Council (UK)

Sponsor details

MRC Centre London
Stephenson House
158-160 North Gower Street
London
NW1 2ND
United Kingdom

Sponsor type

Research council

Website

Funders

Funder type

Charity

Funder name

Monument Trust (UK) (ref: grant ID - MON4951)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes