Safety and Efficacy of Kaletra in ARV Therapy Experienced... | NCT00648999

Studies
Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients

NCT00648999

Sponsor

AbbVie (prior sponsor, Abbott)

Status

Completed

Last Update Posted

Mar 15, 2013Estimated

Enrollment

207Actual

Phase

Phase 4

Conditions

Human Immunodeficiency Virus

Interventions

lopinavir/ritonavir

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2003

Primary Completion Date

Dec 2006Actual

Completion Date

Dec 2006Actual

First Submitted Date

Mar 28, 2008

First Submission Date that Met QC Criteria

Mar 31, 2008

First Posted Date

Apr 1, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2013

Last Update Posted Date

Mar 15, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To demonstrate that patients treated with Kaletra have an improvement in their quality of life compared to the quality of life they had with their previous NRTI therapy.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

207Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Drug: lopinavir/ritonavir
2	Active Comparator		Drug: lopinavir/ritonavir

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lopinavir/ritonavir	Drug	lopinavir/ritonavir 400 mg/100 mg bid 48 weeks of treatment	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of Life		Baseline, Week 4, Week 24 and Week 48
CD4		Baseline, Week 24 and Week 48

Secondary Outcomes

Measure	Description	Time Frame
Adverse Event Monitoring		Baseline, Week 4, Week 24 and Week 48

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HIV Infected subjects
Subjects failing in current HIV treatment, or
Subjects with a viral load < 400 copies/mL and not tolerating their current HIV treatment.

Exclusion Criteria:

Subject is currently participating in another clinical study or has participated in another clinical study within 30 days prior to screening visit
Subject is pregnant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jose Canadas, MD	AbbVie	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Site Ref # / Investigator 4074		León	Guanajauto		Mexico
Site Ref # / Investigator 4049

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D000163	Acquired Immunodeficiency Syndrome

Ancestor Terms

ID	Term
D015658	HIV Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D061466	Lopinavir
C558899	lopinavir-ritonavir drug combination

Ancestor Terms

ID	Term
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided