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BOOST: Study of Increased Dosage of Lopinavir/Ritonavir (LPV/r)

Primary Purpose

HIV Infections

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Increased dose of Kaletra

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV/AIDS, viremia, Kaletra, pharmacokinetics, viral load, LPV/r, Treatment Experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

CD4 Count >50
Viral load 200-75,000 on two most recent measures
More than 16 weeks on standard dose Kaletra (LPV/r)
May be initial PI regimen or prior PI usage
Up to 50-fold resistance to LPV/r

Exclusion Criteria:

Age < 18 years old

Sites / Locations

Community Research Initiative of New England - Boston

Outcomes

Primary Outcome Measures

To evaluate the pharmacokinetic parameters of higher doses of LPV/r

Secondary Outcome Measures

To evaluate plasma HIV-1 RNA change after increasing the dose of LPV/r

To evaluate change in CD4 count after increased dose LPV/r

To compare the tolerability and laboratory safety profile of LPV/r 3 and 4 tablets BID

Full Information

NCT ID

NCT00414284

First Posted

December 20, 2006

Last Updated

December 6, 2010

Sponsor

Community Research Initiative of New England

Collaborators

Abbott

1. Study Identification

Unique Protocol Identification Number

NCT00414284

Brief Title

BOOST: Study of Increased Dosage of Lopinavir/Ritonavir (LPV/r)

Official Title

Evaluation of the Pharmacokinetics and Tolerability of Increased Dosage of Lopinavir/Ritonavir(LPV/r) in Individuals Experiencing Viremia on Standard Dose LPV/r Using LPV/r Tablet Formulation

Study Type

Interventional

2. Study Status

Record Verification Date

December 2010

Overall Recruitment Status

Terminated

Why Stopped

One subject's HIV RNA rebounded at week 12. A repeat PhenoSense GT combination resistance assay at week 12 revealed evolution in protease inhibitor resistance.

Study Start Date

June 2006 (undefined)

Primary Completion Date

April 2007 (Actual)

Study Completion Date

April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Community Research Initiative of New England

Collaborators

Abbott

4. Oversight

5. Study Description

Brief Summary

This study will look to see if increasing the standard dose of Kaletra is tolerated and if it will lower viral loads to undetectable levels. This study will also look at the pharmacokinetic data (amount of Kaletra in blood at different times).

Detailed Description

There are several reasons for low level viremia in patients on Kaletra (LPV/r), including poor adherence, incomplete absorption, cellular drug pumps or resistance mutations. Increasing exposure to protease inhibitors via boosting with ritonavir increases minimum blood concentrations, and is a strategy which has been shown to improve suppression of virologic replication. Little is known about the pharmacokinetics (PK), tolerability and safety of increased doses of LPV/r. The objectives of this 24-week single arm pilot study are to assess the PK parameters, safety, tolerability, change in viral load and CD4 counts on increased dose (600/150 and 800/200 mg) LPV/r in participants with low level viremia on standard dose LPV/r-based ART. Participants will undergo six PK samplings over 12 hours on standard dose LPV/r. The dose will be increased to 3 tabs (600/150) BID and blood will be sampled for PK after two weeks. If tolerated at 8 weeks, the dose will be increased to 4 tabs (800/200 mg) BID and final PK sampling will be performed after two weeks. There will be a one time, optional, optimization of background regimen of NRTIs two weeks after the first dose escalation. Major Eligibility Criteria: CD4 count: > 50 Viral load: 200-75,000 on two most recent measures Current treatment: > 16 weeks standard dose (400/100mg BID) LPV/r-based ART (no other PI or NNRTI allowed Prior treatment experience and resistance profile: Up to 20-fold resistance to LPV/r

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

HIV/AIDS, viremia, Kaletra, pharmacokinetics, viral load, LPV/r, Treatment Experienced

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Increased dose of Kaletra

Primary Outcome Measure Information:

Title

To evaluate the pharmacokinetic parameters of higher doses of LPV/r

Secondary Outcome Measure Information:

Title

To evaluate plasma HIV-1 RNA change after increasing the dose of LPV/r

Title

To evaluate change in CD4 count after increased dose LPV/r

Title

To compare the tolerability and laboratory safety profile of LPV/r 3 and 4 tablets BID

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Eligibility Criteria

Inclusion Criteria: CD4 Count >50 Viral load 200-75,000 on two most recent measures More than 16 weeks on standard dose Kaletra (LPV/r) May be initial PI regimen or prior PI usage Up to 50-fold resistance to LPV/r Exclusion Criteria: Age < 18 years old

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Calvin J Cohen, MD, MSc

Organizational Affiliation

CRI

Official's Role

Principal Investigator

Facility Information:

Facility Name

Community Research Initiative of New England - Boston

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.crine.org/

Description

Web page of CRI, the nonprofit research group sponsoring the study

Learn more about this trial

BOOST: Study of Increased Dosage of Lopinavir/Ritonavir (LPV/r)

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