NCT00414284

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_4 hiv-infections

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 21, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

December 8, 2010

Status Verified

December 1, 2010

Enrollment Period

10 months

First QC Date

December 20, 2006

Last Update Submit

December 6, 2010

Conditions

HIV Infections

Keywords

HIV/AIDSviremiaKaletrapharmacokineticsviral loadLPV/rTreatment Experienced

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

  • 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

Interventions

Increased dose of KaletraDRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age \< 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Research Initiative of New England - Boston

Boston, Massachusetts, 02215, United States

Location

Related Links

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeViremia

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus DiseasesSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Calvin J Cohen, MD, MSc

    CRI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 20, 2006

First Posted

December 21, 2006

Study Start

June 1, 2006

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

December 8, 2010

Record last verified: 2010-12

Locations

US(1)