TDM of Generic Lopinavir/Ritonavir 200/50 mg

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluating the bioavailibility safety and efficacy of the generic LPV/RTV 200/50 mg tablet formulation in a 400/100 mg BID dose in Thai HIV infected individuals.

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

Details

• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
• Collaborator: The Government Pharmaceutical Organization
• 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. 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