HIV InfectionPhase 1PENTA 13NCT01982396
Pharmacokinetic (PK) Study of Twice Daily vs Once Daily Lamivudine (3TC) and Abacavir (ABC) as Part of Combination Antiretroviral Therapy (ART) in HIV Infected Children
A Phase 1 study testing ABC Twice Daily, ABC Once Daily and 3TC Once Daily in people with HIV Infection, run by PENTA Foundation at 2 sites in United Kingdom.
Trial summary
Cross-over 28 week study of the plasma pharmacokinetic profiles of twice daily 3TC (4mg/kg/dose BD) with once daily 3TC (8mg/kg/dose OD) and twice daily ABC (8mg/kg/dose BD) with daily ABC (16mg/kg/dose OD) where one or both drugs are being taken as part of combination antiretroviral therapy. Read more about this study
- Who is it for?
- Ages 2 to 13 years
- Conditions the study is for
- HIV Infection
- What is being tested?
- ABC Twice Daily, ABC Once Daily and 3TC Once Daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2003to Mar 2004
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 2 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with definitive HIV infection
- Age > 2 and < 13 years
- Currently on combination ART including 3TC and / or ABC, for at least 6 months, with stable CD4 cell count and HIV RNA viral load and expected to stay on this regimen for at least a further 3 months.
Who cannot join
- • Intercurrent illness
- Receiving concomitant therapy except prophylaxis against Pneumocystis carinii pneumonia (PCP)
- Abnormal renal or liver function (grade 3 or above)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Great Ormond Street Hospital
London
St. Mary's Hospital
London
About this study
Official title: Pharmacokinetic Study of Twice Daily vs Once Daily Lamivudine and Abacavir as Part of Combination Antiretroviral Therapy in Children With HIV Infection
Cross-over 28 week study of the plasma pharmacokinetic profiles of twice daily 3TC (4mg/kg/dose BD) with once daily 3TC (8mg/kg/dose OD) and twice daily ABC (8mg/kg/dose BD) with daily ABC (16mg/kg/dose OD) where one or both drugs are being taken as part of combination antiretroviral therapy.
- Conditions
- HIV Infection
- Being tested
- ABC Twice Daily, ABC Once Daily, 3TC Once Daily, 3TC Twice Daily
- Keywords
- HIV, paediatric, Abacavir, lamivudine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABC Twice DailyDrug
ABC Once DailyDrug
3TC Once DailyDrug
3TC Twice DailyDrug
| Study group | Role | What they receive |
|---|---|---|
| Twice daily | Active comparator | Not described Receives: Drug: ABC Twice Daily; Drug: 3TC Twice Daily |
| Once daily | Experimental | Not described Receives: Drug: ABC Once Daily; Drug: 3TC Once Daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Curve (AUC) of lamivudine after qd and bid dosing
Measured: week 0 and Week 4
Cmin of lamivudine after qd and bid dosing
Measured: week 0 and week 4
Cmax of lamivudine after qd and bid dosing
Measured: week 0 and week 4
AUC of abacavir after qd and bid dosing
Measured: week 0 and week 4
Cmin of abacavir after qd and bid dosing
Measured: week 0 and week 4
Cmax of abacavir after qd and bid dosing
Measured: week 0 and week 4
Secondary outcomes (1)
To describe trough intracellular levels of 3TC on twice daily and once daily dosage regimens
Measured: Week 0 and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startJan 2003
- Primary completionFeb 2004
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- PENTA Foundation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Vas Novelli, MD, Principal investigator, Great Ormond Street Hospital for Children, London, UKHermione Lyall, MD, Principal investigator, St. Mary's Hospital, London, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982396
- Sponsor's protocol ID
- PENTA 13
- Acronym
- PENTA 13
- Status last verified
- Nov 2013
- First submitted
- 25 Oct 2013
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bergshoeff A, Burger D, Verweij C, Farrelly L, Flynn J, Le Prevost M, Walker S, Novelli V, Lyall H, Khoo S, Gibb D; PENTA-13 Study Group. Plasma pharmacokinetics of once- versus twice-daily lamivudine and abacavir: simplification of combination treatment in HIV-1-infected children (PENTA-13). Antivir Ther. 2005;10(2):239-46.
PubMed 15865218LePrevost M, Green H, Flynn J, Head S, Clapson M, Lyall H, Novelli V, Farrelly L, Walker AS, Burger DM, Gibb DM; Pediatric European Network for the Treatment of AIDS 13 Study Group. Adherence and acceptability of once daily Lamivudine and abacavir in human immunodeficiency virus type-1 infected children. Pediatr Infect Dis J. 2006 Jun;25(6):533-7. doi: 10.1097/01.inf.0000222415.40563.d4.
PubMed 16732152
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Twice Daily vs Once Daily Lamivudine and Abacavir as Part of Combination Antiretroviral Therapy in Children With HIV Infection
- ClinicalTrials.gov ID
- NCT01982396
- Acronym / sponsor ID
- PENTA 13 / PENTA 13
- Conditions
- HIV Infection
- Keywords
- HIV, paediatric, Abacavir, lamivudine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- PENTA FoundationResearch network
- Study start
- Jan 2003
- Primary completion
- Feb 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cross-over 28 week study of the plasma pharmacokinetic profiles of twice daily 3TC (4mg/kg/dose BD) with once daily 3TC (8mg/kg/dose OD) and twice daily ABC (8mg/kg/dose BD) with daily ABC (16mg/kg/dose OD) where one or both drugs are being taken as part of combination antiretroviral therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Twice daily | Active comparator | Drug: ABC Twice Daily, Drug: 3TC Twice Daily |
| Once daily | Experimental | Drug: ABC Once Daily, Drug: 3TC Once Daily |
Who may qualify
- Ages
- 2 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children with definitive HIV infection
- Age > 2 and < 13 years
- Currently on combination ART including 3TC and / or ABC, for at least 6 months, with stable CD4 cell count and HIV RNA viral load and expected to stay on this regimen for at least a further 3 months.
Key exclusion criteria (3 listed)
- • Intercurrent illness
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 |
|---|---|---|
| ABC Twice Daily | Drug | Twice daily |
| ABC Once Daily | Drug | Once daily |
| 3TC Once Daily | Drug | Once daily |
| 3TC Twice Daily | Drug | Twice daily |
Primary outcome
Area Under Curve (AUC) of lamivudine after qd and bid dosing
Time frame: week 0 and Week 4
Cmin of lamivudine after qd and bid dosing
Time frame: week 0 and week 4
Cmax of lamivudine after qd and bid dosing
Time frame: week 0 and week 4
AUC of abacavir after qd and bid dosing
Time frame: week 0 and week 4
Cmin of abacavir after qd and bid dosing
Time frame: week 0 and week 4
Cmax of abacavir after qd and bid dosing
Time frame: week 0 and week 4
1 secondary outcome
To describe trough intracellular levels of 3TC on twice daily and once daily dosage regimens
Time frame: Week 0 and week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.
- Background: PubMed 15865218Bergshoeff A, Burger D, Verweij C, Farrelly L, Flynn J, Le Prevost M, Walker S, Novelli V, Lyall H, Khoo S, Gibb D; PENTA-13 Study Group. Plasma pharmacokinetics of once- versus twice-daily lamivudine and abacavir: simplification of combination treatment in HIV-1-infected children (PENTA-13). Antivir Ther. 2005;10(2):239-46.
- Background: PubMed 16732152LePrevost M, Green H, Flynn J, Head S, Clapson M, Lyall H, Novelli V, Farrelly L, Walker AS, Burger DM, Gibb DM; Pediatric European Network for the Treatment of AIDS 13 Study Group. Adherence and acceptability of once daily Lamivudine and abacavir in human immunodeficiency virus type-1 infected children. Pediatr Infect Dis J. 2006 Jun;25(6):533-7. doi: 10.1097/01.inf.0000222415.40563.d4.
- PENTA 13 publications and presentationsLink 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.
Vas Novelli, MD principal investigator
Great Ormond Street Hospital for Children, London, UK
Hermione Lyall, MD principal investigator
St. Mary's Hospital, London, UK
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABC Twice Daily, ABC Once Daily and 3TC Once Daily in people with HIV Infection, run by PENTA Foundation at 2 sites in United Kingdom.
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 3 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 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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) of lamivudine after qd and bid dosing (time frame: week 0 and Week 4). The study lists 6 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 NCT01982396, which also lists 2 linked publications.
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 13 Nov 2013.