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| Name | Class |
|---|---|
| UNITAID | OTHER |
| AMS-PHPT Research Platform (Program for HIV Prevention and Treatment) | UNKNOWN |
| Joint Clinical Research Centre- Kampala | UNKNOWN |
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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 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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4in1 granules | Experimental | Abacavir/Lamivudine/ Lopinavir/Ritonavir (30/15/ 40/10mg ;4-in-1) Fixed-Dose Combination in granules formulation administered twice daily for at least 3 weeks, Followed by Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg dispersible tablets) administered twice daily for at least 3 weeks. |
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| LPV/r Pellets Plus ABC/3TC | Experimental | Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg dispersible tablets) administered twice daily for at least 3 weeks. Followed by Abacavir/Lamivudine/ Lopinavir/Ritonavir (30/15/ 40/10mg ;4-in-1) Fixed-Dose Combination in granules formulation administered twice daily for at least 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABC/3TC/LPV/r granules (30/15/40/10 mgs) | Drug | This is a fixed dose combination. Each capsule contains Lopinavir (40mg), Ritonavir (10mg), Abacavir (30mg) and Lamivudine (15mg) in granules formulation. Dosage according to patient's weight: Between 3 and 5.9kg: 2 capsules twice a day Between 6 and 9.9kg: 3 capsules twice a day Between 10 and 13.9kg: 4 capsules twice a day Between 14 and 19.9kg: 5 capsules twice a day Between 20 and 24.9kg: 6 capsules twice a day |
| Measure | Description | Time Frame |
|---|---|---|
| 0 -12 hours Area under the curve plasma concentration versus time for LPV, ABC and 3TC in the 4-in- formulation | 0 -12 hours Area under the curve plasma concentration versus time for LPV, ABC and 3TC in the 4-in- formulation | 0-12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration at 12 hours for LPV in the 4in1 formulation | Plasma concentration at 12 hours for LPV in the 4in1 formulation | 12 hours |
| Peak plasma concentration (Cmax) of LPV, ABC and 3TC with the 4-in-1 formulation. |
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Inclusion Criteria:
Children > 4 weeks old and weighing ≥3 and <25 kg at the time of enrolment
Past or current documentation of a confirmed diagnosis of HIV infection defined as two positive assays from two different samples. The two results may be in any combination of the following:
At any age: HIV-1 DNA PCR positive
Documented past HIV-1 RNA viral load > 1,000 copies/mL plasma
At any age >18 months of age: HIV-1 antibody reactive on two different rapid tests based on national testing algorithm
ARV treatment eligible children with LPV-based treatment indication* as defined by country-specific guidelines or the WHO paediatric treatment guidelines and confirmed by the investigator
HIV RNA viral load <1000 copies/mL (suppressed) at the screening visit*
Inability to swallow LPV/r tablets
Parent or guardian able and willing to provide written informed consent.
For lowest weight band (≥3 and ≤ 5.9kgs) ONLY: under treatment for at least 3 weeks but not more than 12 weeks.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabelle Andrieux-Meyer, MD | Contact | +41 22 906 92 68 | iandrieux-meyer@dndi.org |
| Name | Affiliation | Role |
|---|---|---|
| Isabelle Andrieux-Meyer, MD | Drugs for Neglected Diseases initiative | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine Children's Foundation Uganda | Recruiting | Kampala | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36968554 | Derived | Rotsaert A, Ogara C, Mwanga-Amumpaire J, Kekitiinwa AR, Musiime V, Najjingo E, Kisitu GP, Nazzinda R, Nambi E, Lee J, Diallo M, Kyomuhendo F, Waweru M, Andrieux-Meyer I, Nostlinger C. Acceptability of a new 4-in-1 Abacavir/Lamivudine/Lopinavir/Ritonavir paediatric fixed-dose combination: the caregiver-child dyads' perspective. Ther Adv Infect Dis. 2023 Mar 21;10:20499361231159993. doi: 10.1177/20499361231159993. eCollection 2023 Jan-Dec. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 21, 2022 | |
| Reset | Mar 23, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 21, 2022 | Mar 23, 2022 |
| Baylor College of Medicine Children's Foundation |
| OTHER |
| Epcentre Centre Mbarara Research Centre | UNKNOWN |
| Institute of Tropical Medicine, Belgium | OTHER |
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| LPV/r Pellets (40/10mgs) plus ABC/3TC (60/30mgs) | Drug | Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg dispersible tablets) Dosage according to patient's weight: LPV/r Pellets: Between 3 and 5.9kg: 2 capsules twice a day Between 6 and 9.9kg: 3 capsules twice a day Between 10 and 13.9kg: 4 capsules twice a day Between 14 and 19.9kg: 5 capsules twice a day Between 20 and 24.9kg: 6 capsules twice a day ABC/3TC: Between 3 and 5.9kg: 1 tablet twice a day Between 6 and 9.9kg: 1.5 tablets twice a day Between 10 and 13.9kg: 2 tablets twice a day Between 14 and 19.9kg: 2.5 tablets twice a day Between 20 and 24.9kg: 3 tablets twice a day |
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Plasma concentration maximum of LPV, ABC and 3TC with the 4-in-1 formulation.
| 3-5 weeks |
| Concentration time maximum for LPV, ABC and 3TC with the 4-in-1 formulation. | Concentration time maximum for LPV, ABC and 3TC with the 4-in-1 formulation. | 3-5 weeks |
| Clearance function for LPV, ABC and 3TC with the 4-in-1 formulation. | Clearance function for LPV, ABC and 3TC with the 4-in-1 formulation. | 3-5 weeks |
| Geometric mean ratio (GMR) of steady state LPV, ABC and 3TC versus time (0-12) in the 4-in-1 formulation versus the reference treatment regimen | Geometric mean ratio (GMR) of steady state LPV, ABC and 3TC versus time (0-12) in the 4-in-1 formulation versus the reference treatment regimen. | 0 - 12 hours |
| Area under curve plasma concentration versus time (0-12) in the 4-in-1 formulation versus the reference treatment regimen. | Area under curve plasma concentration versus time (0-12) in the 4-in-1 formulation versus the reference treatment regimen. | 0 - 12 hours |
| Geometric mean ratio (GMR) of steady state LPV, ABC and 3TC in the 4-in-1 formulation versus the reference treatment regimen. | Geometric mean ratio (GMR) of steady state LPV, ABC and 3TC in the 4-in-1 formulation versus the reference treatment regimen. | 0 - 12 hours |
| Peak plasma concentration in the 4-in-1 formulation versus the reference treatment regimen. | Peak plasma concentration in the 4-in-1 formulation versus the reference treatment regimen. | 3-5 weeks |
| Safety: A description of the proportion of children experiencing an Adverse event or Serious Adverse event binomial distribution compared between the two formulations. | Safety: A description of the proportion of children experiencing an Adverse event or Serious Adverse event binomial distribution compared between the two formulations. | 6-8 weeks |
| Safety: Summary of the number and percent of subjects with documented Grade 3 or higher adverse events; each summary will be conducted overall and by formulation | Safety: Summary of the number and percent of subjects with documented Grade 3 or higher adverse events; each summary will be conducted overall and by formulation | 6-8 weeks |
| Proportion of children with viral load <1000 copies/ml | Comparison of proportion of children with viral load less than 1000 copies/ml at baseline and at end of the study. | 6-8 weeks |
| Changes in CD4 counts compared to baseline | Changes in CD4 counts compared to baseline | 6-8 week |
| Changes in CD4 percentage compared to baseline | Changes in CD4 percentage compared to baseline | 6-8 weeks |
| Acceptability: Description of factors that affect acceptability of the 4 in1 formulation | Description of factors that affect acceptability of the 4in1 formulation as reported by the caregivers | 6-8 weeks |
| Joint Clinical research Centre | Recruiting | Kampala | Uganda |
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| Epicentre Mbarara Research Centre | Recruiting | Mbarara | Uganda |
|