HIV InfectionPhase 1PENTA15NCT01973439
PENTA15: Pharmacokinetic Study of Once Versus Twice Daily Abacavir in HIV-1 Infected Children Aged 3 to <36 Months
A Phase 1 study testing Intervention 1: PK assessment while on Twice Daily Abacavir and Intervention 2: PK assessment while on Once Daily Abacavir in people with HIV Infection, run by PENTA Foundation at 10 sites in 5 countries.
Trial summary
To compare the plasma pharmacokinetic (PK) parameters of q24h versus q12h dosing of abacavir in HIV-1-infected infants and children aged 3 months to 36 months The secondary objectives of PENTA15 were: To compare the plasma PK parameters of q24h versus q12h dosing of lamivudine in HIV-1-infected infants and children… Read more about this study
- Who is it for?
- Ages 3 to 36 months
- Conditions the study is for
- HIV Infection
- What is being tested?
- Intervention 1: PK assessment while on Twice Daily Abacavir and Intervention 2: PK assessment while on Once Daily Abacavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 10 sitesin 5 countries
- Study dates
- Jul 2006to Jun 2009
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants and children with confirmed presence of HIV-1 infection
- Infants and children aged 3 to <36 months
- Parents/guardians able and willing to give written, informed consent
- Currently on combination ART including Abacavir (ABC) oral solution with or without Lamivudine (3TC) oral solution, for at least 12 weeks and expected to stay on this regimen for at least a further 12 weeks.
- HIV-1 RNA viral load either;
- suppressed HIV-1 RNA viral load (i.e. <400 copies/ml)
- non-suppressed, but low, HIV-1 RNA viral load (i.e. 400-20 000 copies/ml). The non-suppressed children should have had a stable or decreasing HIV-1 RNA viral load prior to study entry and should be considered to be still gaining benefit from the current regimen
- Stable or rising CD4+ cell percent prior to study entry and should not be expected to fall within the next 12 weeks.
Who cannot join
- Intercurrent illness
- Receiving concomitant therapy except prophylactic antibiotics
- Abnormal renal or liver function (grade 3 or above)
Trial locations and contacts
10 sites in 5 countries.
10 sites in 5 countries
Spain3 sites
Hospital Universitario
Getafe
Hospital 12 de Octubre
Madrid
Hospital Gregorio Maranon
Madrid
United Kingdom3 sites
Birmingham Heartlands Hospital
Birmingham
Evelina Children's Hospital
London
St. Mary's Hospital
London
About this study
Official title: PENTA15: Plasma Pharmacokinetic Study of Once Versus Twice Daily Abacavir as Part of Combination Antiretroviral Therapy in Children With HIV-1 Infection Aged 3 Months to <36 Months
To compare the plasma pharmacokinetic (PK) parameters of q24h versus q12h dosing of abacavir in HIV-1-infected infants and children aged 3 months to 36 months
The secondary objectives of PENTA15 were:
Read more
To compare the plasma PK parameters of q24h versus q12h dosing of lamivudine in HIV-1-infected infants and children aged 3 months to 36 months who were receiving lamivudine in combination with abacavir
To compare age-related differences in the PK parameters of q24h versus q12h dosing of abacavir and lamivudine infants and children in 3 age groups (≥3 to <12 months, ≥12 to <24 months and ≥24 to <36 months)
To describe child and family acceptability of and adherence to q24h compared to q12h dosage regimens of abacavir and lamivudine
- Conditions
- HIV Infection
- Being tested
- Intervention 1: PK assessment while on Twice Daily Abacavir, Intervention 2: PK assessment while on Once Daily Abacavir
- Keywords
- HIV, Abacavir, Lamivudine, Pharmacokinetics
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention 1: PK assessment while on Twice Daily AbacavirOther
Also called Ziagen, ABC
Week 0
Intervention 2: PK assessment while on Once Daily AbacavirOther
Also called Ziagen, ABC
Week 4
| Study group | Role | What they receive |
|---|---|---|
| Abacavir Once versus Twice Daily | Other | This is a single arm study. Intervention 1: PK assessment while on Twice Daily Abacavir (Week 0) Intervention 2: PK assessment while on Once Daily Abacavir (Week 4) Receives: Other: Intervention 1: PK assessment while on Twice Daily Abacavir; Other: Intervention 2: PK assessment while on Once Daily Abacavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Curve (AUC) (0-24) of Abacavir on Twice Daily Dosing
Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.
Measured: Week 0
Cmax of Abacavir on Twice Daily Dosing
Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.
Measured: Week 0
AUC(0-24) of Abacavir on Once Daily Dosing
Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication
Measured: Week 4
Cmax of Abacavir on Once Daily Dosing
Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startJul 2006
- Primary completionJun 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- PENTA Foundation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973439
- Sponsor's protocol ID
- PENTA15
- Other IDs
- 2005-004433-18, 2005
- Acronym
- PENTA15
- Status last verified
- Feb 2014
- First submitted
- 25 Oct 2013
- Last updated
- 20 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Paediatric European Network for Treatment of AIDS (PENTA). Pharmacokinetic study of once-daily versus twice-daily abacavir and lamivudine in HIV type-1-infected children aged 3-<36 months. Antivir Ther. 2010;15(3):297-305. doi: 10.3851/IMP1532.
PubMed 20516550
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PENTA15: Plasma Pharmacokinetic Study of Once Versus Twice Daily Abacavir as Part of Combination Antiretroviral Therapy in Children With HIV-1 Infection Aged 3 Months to <36 Months
- ClinicalTrials.gov ID
- NCT01973439
- Acronym / sponsor ID
- PENTA15 / PENTA15
- Conditions
- HIV Infection
- Keywords
- HIV, Abacavir, Lamivudine, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- PENTA FoundationResearch network
- Study start
- Jul 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 31 Oct 2013 (estimated)
- Results
- Posted 20 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the plasma pharmacokinetic (PK) parameters of q24h versus q12h dosing of abacavir in HIV-1-infected infants and children aged 3 months to 36 months
The secondary objectives of PENTA15 were:
To compare the plasma PK parameters of q24h versus q12h dosing of lamivudine in HIV-1-infected infants and children aged 3 months to 36 months who were receiving lamivudine in combination with abacavir
To compare age-related differences in the PK parameters of q24h versus q12h dosing of abacavir and lamivudine infants and children in 3 age groups (≥3 to <12 months, ≥12 to <24 months and ≥24 to <36 months)
To describe child and family acceptability of and adherence to q24h compared to q12h dosage regimens of abacavir and lamivudine
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abacavir Once versus Twice Daily | Other | Other: Intervention 1: PK assessment while on Twice Daily Abacavir, Other: Intervention 2: PK assessment while on Once Daily AbacavirThis is a single arm study. Intervention 1: PK assessment while on Twice Daily Abacavir (Week 0) Intervention 2: PK assessment while on Once Daily Abacavir (Week 4) |
Who may qualify
- Ages
- 3 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Infants and children with confirmed presence of HIV-1 infection
- Infants and children aged 3 to <36 months
- Parents/guardians able and willing to give written, informed consent
- Currently on combination ART including Abacavir (ABC) oral solution with or without Lamivudine (3TC) oral solution, for at least 12 weeks and expected to stay on this regimen for at least a further 12 weeks.
- HIV-1 RNA viral load either;
Key exclusion criteria (3 listed)
- Intercurrent illness
- Receiving concomitant therapy except prophylactic antibiotics
- Abnormal renal or liver function (grade 3 or above)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention 1: PK assessment while on Twice Daily AbacavirAlso: Ziagen, ABCWeek 0 | Other | Abacavir Once versus Twice Daily |
| Intervention 2: PK assessment while on Once Daily AbacavirAlso: Ziagen, ABCWeek 4 | Other | Abacavir Once versus Twice Daily |
Primary outcome
Area Under Curve (AUC) (0-24) of Abacavir on Twice Daily Dosing
Time frame: Week 0
Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.
Cmax of Abacavir on Twice Daily Dosing
Time frame: Week 0
Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.
AUC(0-24) of Abacavir on Once Daily Dosing
Time frame: Week 4
Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication
Cmax of Abacavir on Once Daily Dosing
Time frame: Week 4
Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20516550Paediatric European Network for Treatment of AIDS (PENTA). Pharmacokinetic study of once-daily versus twice-daily abacavir and lamivudine in HIV type-1-infected children aged 3-<36 months. Antivir Ther. 2010;15(3):297-305. doi: 10.3851/IMP1532.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intervention 1: PK assessment while on Twice Daily Abacavir and Intervention 2: PK assessment while on Once Daily Abacavir in people with HIV Infection, run by PENTA Foundation at 10 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain, United Kingdom, France, Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under Curve (AUC) (0-24) of Abacavir on Twice Daily Dosing (time frame: Week 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01973439, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2014.