Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-03-01 @ 6:28 AM
Study NCT ID:
NCT03836833
Status:
UNKNOWN
Last Update Posted:
2019-06-07
First Post:
2018-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lopinavir/r/ Lamivudine/ Abacavir as an Easy to Use Paediatric Formulation
Sponsor:
Drugs for Neglected Diseases
Organization:
Study Overview
Official Title:
Pharmacokinetic, Safety and Acceptability Study of the Abacavir/Lamivudine/Lopinavir/Ritonavir/-30/15/ 40/10mg vs. Lopinavir/Ritonavir 40/10mg Pellets Plus Dual Abacavir/Lamivudine-60/30mg Tablets in HIV Infected Children
Status:
UNKNOWN
Status Verified Date:
2019-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LOLIPOP
Brief Summary:
A phase I/II, open label, randomized crossover pharmacokinetic, safety and acceptability study of the Abacavir/Lamivudine/ Lopinavir/Ritonavir (30/15/ 40/10mg ;4-in-1) Fixed-Dose Combination vs. Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg tablets) in HIV infected Children.
The study is intended to support the adoption of the 4-in-1 by healthcare providers and will provide data that may support its registration in certain countries. The study will be carried out in HIV-infected children in Uganda weighing 3 to 25 kg (inclusive) and unable to swallow tablets and will provide supportive clinical data on the pharmacokinetics, safety, tolerability and acceptability of the 4-in-1.
The study is intended to support the adoption of the 4-in-1 by healthcare providers and will provide data that may support its registration in certain countries. The study will be carried out in HIV-infected children in Uganda weighing 3 to 25 kg (inclusive) and unable to swallow tablets and will provide supportive clinical data on the pharmacokinetics, safety, tolerability and acceptability of the 4-in-1.
Detailed Description:
The primary objective is to estimate the population average exposure to LPV, ABC and 3TC provided by the 4-in-1 formulation in HIV-infected children dosed per WHO weight bands.
The secondary objectives:
* To determine the proportion of children overall, and within each weight band, with a lopinavir C12 \<1.0 mg/L while receiving the 4-in-1 formulation
* To evaluate and compare the safety and tolerability of the 4-in-1 formulation versus a reference treatment regimen.
* To compare the bioavailability of LPV, ABC and 3TC in the 4-in-1 formulation versus a reference treatment regimen.
* To assess post exposure CD4 and viral load
* To assess the factors that contribute to acceptability of the new 4-in-1 formulation.
The secondary objectives:
* To determine the proportion of children overall, and within each weight band, with a lopinavir C12 \<1.0 mg/L while receiving the 4-in-1 formulation
* To evaluate and compare the safety and tolerability of the 4-in-1 formulation versus a reference treatment regimen.
* To compare the bioavailability of LPV, ABC and 3TC in the 4-in-1 formulation versus a reference treatment regimen.
* To assess post exposure CD4 and viral load
* To assess the factors that contribute to acceptability of the new 4-in-1 formulation.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: