NCT01103596

Brief Summary

The purpose of this study is to evaluate, in patients in at least the second protease inhibitor (PI) line, the virological failures under Kaletra® and their consequences on protease and reverse transcriptase genotypes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

19 active sites

Status
completed

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

March 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 14, 2010

Completed
Last Updated

December 14, 2011

Status Verified

December 1, 2011

Enrollment Period

1.3 years

First QC Date

February 24, 2010

Last Update Submit

December 13, 2011

Conditions

HIV Infection

Keywords

Evaluation of the impact of Kaletra on antiretroviral resistance

Outcome Measures

Primary Outcomes (2)

  • Genotype for resistance determination

    Over the duration of the enrollment for each wave, over a total period of 18 months

  • Description of the predictive factors for mutations and of the impact they could have on other protease inhibitors (PIs) used as maintenance treatment (analysis based on available algorithms).

    Over the duration of the enrollment for each wave, over a total period of 18 months

Study Arms (2)

HIV-infected patients, 1st wave

HIV-infected ARV-experienced patients treated by a combination including Kaletra

HIV-infected patients, 2nd wave

HIV-infected ARV-experienced patients treated by a combination including Kaletra

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Virology laboratories

You may qualify if:

  • Patient aged under 18 years,
  • Pre-treated by at least one protease inhibitor (PI) line,
  • In therapeutic failure of the antiretroviral (ARV) maintenance treatment containing Kaletra®.
  • Therapeutic failure is defined by a viral load\> 50 copies/ml after at least three months' treatment with an ARV combination containing Kaletra®, always provided that genotyping is possible .

You may not qualify if:

  • Patients having received less than three months of Kaletra®,
  • Patients for whom the genotype information before starting Kaletra® and at the time of the failure of Kaletra® was not available,
  • Patients receiving another protease inhibitor (PI) concomitantly with Kaletra®.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Site Reference ID/Investigator# 27801

Angers, 49100, France

Location

Site Reference ID/Investigator# 27799

Bordeaux, 33075, France

Location

Site Reference ID/Investigator# 27790

Grenoble, 38043, France

Location

Site Reference ID/Investigator# 27796

Lille, 59037, France

Location

Site Reference ID/Investigator# 27786

Montpellier, 34295, France

Location

Site Reference ID/Investigator# 27800

Nantes, 44093, France

Location

Site Reference ID/Investigator# 27798

Nice, 06202, France

Location

Site Reference ID/Investigator# 27792

Nîmes, 30029, France

Location

Site Reference ID/Investigator# 5595

Paris, 75013, France

Location

Site Reference ID/Investigator# 27787

Paris, 75475, France

Location

Site Reference ID/Investigator# 27797

Paris, 75571, France

Location

Site Reference ID/Investigator# 27783

Paris, 75877, France

Location

Site Reference ID/Investigator# 27802

Paris, 75908, France

Location

Site Reference ID/Investigator# 27785

Paris, 75970, France

Location

Site Reference ID/Investigator# 27791

Rennes, 35700, France

Location

Site Reference ID/Investigator# 27788

Rouen, 76000, France

Location

Site Reference ID/Investigator# 27789

Toulon, 83056, France

Location

Site Reference ID/Investigator# 27794

Toulouse, 31000, France

Location

Site Reference ID/Investigator# 27784

Villejuif, 94804, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Frozen plasma for determination of Lopinavir/ritonavir (LPV/r) Cmin

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Isabelle Cohen Codar, PharmD

    Abbott France

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2010

First Posted

April 14, 2010

Study Start

March 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

December 14, 2011

Record last verified: 2011-12

Locations

FR(19)