HIV/AIDS
Conditions
Interventions
4in1 Arm
LPV R Pellets Plus ABC 3TC Arm
Sponsors
Drugs for Neglected Diseases initiative
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Children > 4 weeks old and weighing =3 and 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •LPV, ABC and 3TC AUC0-12 in the 4-in-1 formulation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: • LPV C12 with the 4-in-1 formulation. • LPV, ABC and 3TC Cmax, Tmax, CL/F with the 4-in-1 formulation. • Geometric mean ratio (GMR) of steady state LPV, ABC and 3TC AUC0-12 and Cmax in the 4-in-1 formulation versus the reference treatment regimen. Safety, Tolerability: • Occurrence of (treatment-emergent) adverse events (TEAEs) as defined by the protocol • Occurrence of severe treatment-emergent adverse events (TEAEs) as defined by the protocol • Occurrence of treatment-emergent AE (TEAEs) /serious TEAE leading to treatment discontinuation • Occurrence of targeted TEAEs for lopinavir/ritonavir as well as NRTIs (examples: gastrointestinal side effects, liver toxicity, ABC-associated hypersensitivity reaction) • Proportion of children with viral load <1000 copies/ml • Changes in CD4 counts and percent compared to baseline Acceptability: • Factors that affect acceptability of the 4 in1 formulation will be identified by means of a questionnaire and in-depth interviews | — |
Countries
Uganda
Contacts
Public ContactMoses Waweru
Clinical Trial Manager DNDI
Outcome results
None listed