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Efficacy of Simplified Two Drug Kaletra Regimen vs. Kaletra Triple Drug Standard of Care Regimen in Treatment naïve HIV Infected Patients

NCT ID: NCT00234910

Last Updated: 2008-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2008-06-30

Brief Summary

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The purpose of this study is to obtain a preliminary assessment of the antiviral activity and tolerability of simplified Kaletra dual agent therapy as initial treatment for HIV infection, relative to a Kaletra three drug standard of care reference arm.

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Detailed Description

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Conditions

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HIV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

2 drug arm

Group Type EXPERIMENTAL

Tenofovir DF

Intervention Type DRUG

TDF 300mg QD for 72 wks

lopinavir/ritonavir with 2 Nucleoside RTIs

Intervention Type DRUG

LPV/rSGC 400/100mg BID + 2 nucleoside RTIs as prescribed by the Investigator for 72 wks

B

3 drug arm, SOC

Group Type ACTIVE_COMPARATOR

lopinavir/ritonavir with 2 Nucleoside RTIs

Intervention Type DRUG

LPV/rSGC 400/100mg BID + 2 nucleoside RTIs as prescribed by the Investigator for 72 wks

Interventions

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Tenofovir DF

TDF 300mg QD for 72 wks

Intervention Type DRUG

lopinavir/ritonavir with 2 Nucleoside RTIs

LPV/rSGC 400/100mg BID + 2 nucleoside RTIs as prescribed by the Investigator for 72 wks

Intervention Type DRUG

Other Intervention Names

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ABT-378 Kaletra lopinavir/ritonavir

Eligibility Criteria

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Inclusion Criteria

* HIV positive
* \>18 years of age
* HIV RNA\> 400 copies/mL
* Any CD 4 cell count
* Antiretroviral naïve
* No acute illness

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott

Principal Investigators

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Umberto di Luzio Paparatti, MD

Role: STUDY_DIRECTOR

Abbott

Locations

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Global Medical Information-Abbott

Abbott Park, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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EUDRACT 2004-000786-35

Identifier Type: -

Identifier Source: secondary_id

KALEAD

Identifier Type: -

Identifier Source: secondary_id

ITAL-04-002

Identifier Type: -

Identifier Source: org_study_id

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