HIV Clinical Trial
— LOLIPOPOfficial 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
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 2019 |
Est. primary completion date | November 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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. - Does not apply to the youngest children (=3 and = 5.9kgs) Exclusion Criteria: - Planned or concurrent use of NNRTIs, integrase inhibitors, entry inhibitors, or Protease Inhibitors (PIs) other than LPV/r. - Treatment failure with proven resistances to PIs. - Contraindication to use of PIs - Clinical condition requiring the use of a prohibited medication (see section 7.6) in association with LPV/r, ABC/3TC (Refer to section 7.2- 7.3 of the IB) - Pulmonary Tuberculosis and any clinically significant disease or finding during screening that, in the investigator's opinion, would compromise participation in this study. - Treatment with experimental drugs (except for LPV/r Pellets) for any indication within 30 days prior to study entry - Anticipated transfer of care to a non-participating health facility during the study period |
Country | Name | City | State |
---|---|---|---|
Uganda | Baylor College of Medicine Children's Foundation Uganda | Kampala | |
Uganda | Joint Clinical research Centre | Kampala | |
Uganda | Epicentre Mbarara Research Centre | Mbarara |
Lead Sponsor | Collaborator |
---|---|
Drugs for Neglected Diseases | AMS-PHPT Research Platform (Program for HIV Prevention and Treatment), Baylor College of Medicine Childrens Foundation, Uganda, Epcentre Centre Mbarara Research Centre, Institute of Tropical Medicine, Belgium, Joint Clinical Research Centre- Kampala, UNITAID |
Uganda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | Plasma concentration at 12 hours for LPV in the 4in1 formulation | Plasma concentration at 12 hours for LPV in the 4in1 formulation | 12 hours | |
Secondary | 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. | 3-5 weeks | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Changes in CD4 counts compared to baseline | Changes in CD4 counts compared to baseline | 6-8 week | |
Secondary | Changes in CD4 percentage compared to baseline | Changes in CD4 percentage compared to baseline | 6-8 weeks | |
Secondary | 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 |
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