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

Drugs for Neglected Diseases initiative0 个研究点目标入组 45 人开始时间: 2019年3月14日最近更新: 2023年5月29日

试验速览

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•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)

•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

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