TDM of Generic Lopinavir/Ritonavir 200/50 mg

Launched by THE HIV NETHERLANDS AUSTRALIA THAILAND RESEARCH COLLABORATION · Dec 3, 2008

Keywords

ClinConnect Summary

The original solid oral formulation of lopinavir/ritonavir was a soft gel capsule (SGC) in a 133/33 mg formulation. This formulation requires refrigerated storage and need to be administered with food\[4\]. Recently Abbott developed a new formulation of this fixed combination, a 200/50 mg tablet (Aluvia). This formulation showed to be bioequivalence to the old formulation, don't need refrigerated storage and has diminished food effect\[5\].

This are profound advantages for the developing world, but till now Aluvia is not available in Thailand yet, and if it will, the price might be an issu...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed informed consent
• • 2. Evidence of HIV infection (confirmed positive ELISA and/or documented history of measurable HIV RNA)
• • 3. Age\> 18 years
• • 4. On a standard PI containing HAART regimen with 2 NRTIs with a VL \< 50 copies for at least 12 weeks OR ARV-naive patients, or patient on a NNRTI based regimen
• • 5. Currently having no AIDS defining illness
• • 6. Willing to adhere to the protocol requirements
• Exclusion Criteria:
• • 1. Any history of taking CYP450 inhibitors or inducers, or any gastric acid-reducing drugs within 14 days of enrollment in the study
• • 2. Current pregnancy or lactating
• • 3. Active opportunistic infection
• • 4. ALT/ AST more than 2 x upper limit
• • 5. creatinine more than 1.5 time the upper limit
• • 6. Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion
• • 7. History of sensitivity/idiosyncrasy to the drug or chemically related compounds or excipients which may be employed in the study.
• • 8. Active drug abuse