Lopinavir/r/ Lamivudine/ Abacavir as an Easy to Use Paediatric Formulation

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 twopositive assays from two different samples. The two results may be in any combinationof 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 testsbased on national testing algorithm

• ARV treatment eligible children with LPV-based treatment indication* as defined bycountry-specific guidelines or the WHO paediatric treatment guidelines and confirmedby 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 weeksbut 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, orProtease 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) inassociation with LPV/r, ABC/3TC (Refer to section 7.2- 7.3 of the IB)

• Pulmonary Tuberculosis and any clinically significant disease or finding duringscreening that, in the investigator's opinion, would compromise participation in thisstudy.

• 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 studyperiod