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NCT00414284 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00414284
Other study ID # 06-124
Secondary ID IND #71128
Status Terminated
Phase Phase 4
First received December 20, 2006
Last updated December 6, 2010
Start date June 2006
Est. completion date April 2007

Study information
Verified date December 2010
Source Community Research Initiative of New England
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).

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

Recruitment information / eligibility
Status Terminated
Enrollment 0
Est. completion date April 2007
Est. primary completion date April 2007
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Increased dose of Kaletra

Locations
Country Name City State
United States Community Research Initiative of New England - Boston Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Community Research Initiative of New England Abbott

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the pharmacokinetic parameters of higher doses of LPV/r
Secondary To evaluate plasma HIV-1 RNA change after increasing the dose of LPV/r
Secondary To evaluate change in CD4 count after increased dose LPV/r
Secondary To compare the tolerability and laboratory safety profile of LPV/r 3 and 4 tablets BID
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