Status:
UNKNOWN
Lopinavir/r/ Lamivudine/ Abacavir as an Easy to Use Paediatric Formulation
Lead Sponsor:
Drugs for Neglected Diseases
Collaborating Sponsors:
UNITAID
AMS-PHPT Research Platform (Program for HIV Prevention and Treatment)
Conditions:
HIV
Eligibility:
All Genders
4+ years
Phase:
PHASE1
PHASE2
Brief 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. Lopin...
Detailed Description
The primary objective is to estimate the population average exposure to LPV, ABC and 3TC provided by the 4-in-1 formulation in HIV-infected children dosed per WHO weight bands. The secondary objectiv...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03836833
Start Date
June 4 2019
End Date
December 1 2019
Last Update
June 7 2019
Active Locations (3)
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1
Baylor College of Medicine Children's Foundation Uganda
Kampala, Uganda
2
Joint Clinical research Centre
Kampala, Uganda
3
Epicentre Mbarara Research Centre
Mbarara, Uganda