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

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Drugs for Neglected Diseases
• Collaborators: 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
• Treatments: Abacavir; Dideoxynucleosides; Lamivudine; Lopinavir; Ritonavir

Criteria

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