Lopinavir (LPV) Dose Reduction

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to study the pharmacokinetics profiles of generic lopinavir/ritonavir and Pediatric Aluvia® at reduced dose by assessing safety, tolerability and efficacy.

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

Details

• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
• Collaborator: Ministry of Education, Thailand
• Treatments: Lopinavir; Ritonavir

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. Have been on standard dose of any PI containing regimen for at least 4 weeks prior to study entry

5. Currently having no AIDS defining illness

6. Plasma HIV RNA < 50 copies/mL for at least 24 weeks

7. 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 2x 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 pharmaceutical excipients which may be employed in the study.

8. Active drug abuse