A Phase 1/2 interventional study of ABC/3TC/LPV/r granules (30/15/40/10 mgs) and LPV/r Pellets (40/10mgs) plus ABC/3TC (60/30mgs) in HIV, sponsored by Drugs for Neglected Diseases. Status unknown at 3 sites in Uganda. Open to participants aged 4 Weeks and older. Per ClinicalTrials.gov, last updated 2019-06-07.
Sponsored by Drugs for Neglected Diseases · Phase 1/2, Interventional, and Treatment
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:
Drugs for Neglected Diseases is the lead sponsor of 58 studies on the registry; 3 are open to participants now.
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For lowest weight band (≥3 and ≤ 5.9kgs) ONLY: under treatment for at least 3 weeks but not more than 12 weeks.
Exclusion Criteria:
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.
Drug: ABC/3TC/LPV/r granules (30/15/40/10 mgs) · Drug: LPV/r Pellets (40/10mgs) plus ABC/3TC (60/30mgs)
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
Drug: ABC/3TC/LPV/r granules (30/15/40/10 mgs) · Drug: LPV/r Pellets (40/10mgs) plus ABC/3TC (60/30mgs)
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
Also known as: 4in1 Granules
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
Also known as: L PV/r Pellets Plus ABC/3TC tablets
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
Time frame: 0-12 hours
Plasma concentration at 12 hours for LPV in the 4in1 formulation
Plasma concentration at 12 hours for LPV in the 4in1 formulation
Time frame: 12 hours
Peak plasma concentration (Cmax) of LPV, ABC and 3TC with the 4-in-1 formulation.
Plasma concentration maximum of LPV, ABC and 3TC with the 4-in-1 formulation.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 6-8 weeks
Changes in CD4 counts compared to baseline
Changes in CD4 counts compared to baseline
Time frame: 6-8 week
Changes in CD4 percentage compared to baseline
Changes in CD4 percentage compared to baseline
Time frame: 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
Time frame: 6-8 weeks
Plan to share: Undecided
Started Jun 2019 (actual). Primary completion is estimated for Nov 2019, 5 months after the start.
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This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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