Lopinavir (LPV) Dose Reduction

NCT ID: NCT01159275

Last Updated: 2020-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-03-31

Brief 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.

Detailed Description

This is a prospective, 2 arms, randomized intensive PK study with cross over design. This design will provide us optimal information to answer our research question. First and most important, we can assess the PK when lopinavir/r is used in a dose reduced form. By randomizing the patients to either Abbott's pediatric Aluvia dose reduction or India generic LPV/r dose reduction will allow us to assess the differences in AE severity and frequency. Using the standard abbott product as a control our study will provide important information about the bioavailability of the generic product. Although it's not an original BE design we must be able to make preliminary comparisons.

Conditions

HIV-1 Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

1

First Generic LPV/r 200/50 mg BID, then cross over to Pediatric Aluvia 200/50 mg BID

Group Type: OTHER

Generic LPV/r and Aluvia (pharmacokinetics)

Intervention Type: DRUG

Generic LPV/r 200/50 mg BID 12 hr PK then cross over to Pediatric Aluvia 200/50 mg BID

2

First Pediatric Aluvia® 200/50 mg BID, then cross over to Generic LPV/r 200/50 mg BID

Group Type: OTHER

Aluvia and Generic LPV/r (pharmacokinetics)

Intervention Type: DRUG

First Pediatric Aluvia® 200/50 mg BID, then cross over to Generic LPV/r 200/50 mg BID

Interventions

Generic LPV/r and Aluvia (pharmacokinetics)

Generic LPV/r 200/50 mg BID 12 hr PK then cross over to Pediatric Aluvia 200/50 mg BID

Intervention Type: DRUG

Aluvia and Generic LPV/r (pharmacokinetics)

First Pediatric Aluvia® 200/50 mg BID, then cross over to Generic LPV/r 200/50 mg BID

Intervention Type: DRUG

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. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Education, Thailand

OTHER

Sponsor Role: collaborator

The HIV Netherlands Australia Thailand Research Collaboration

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anchalee Avihingsanon, MD

Role: PRINCIPAL_INVESTIGATOR

The HIV Netherlands Australia Thailand Research Collaboration

Locations

HIV-NAT, Thai Red Cross AIDS Research Centre

Bangkok, , Thailand

Countries

Thailand

Related Links

http://www.hivnat.org

HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

Other Identifiers

HIV-NAT 085

Identifier Type: -

Identifier Source: org_study_id