MedDataX Logo

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

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

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infection

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Lopinavir Ritonavir Kaletra Tenofovir HIV infection Treatment Naive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ABT-378 Kaletra lopinavir/ritonavir

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Meet the organizations funding or collaborating on the study and learn about their roles.

Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Abbott

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Umberto di Luzio Paparatti, MD

Role: STUDY_DIRECTOR

Abbott

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Global Medical Information-Abbott

Abbott Park, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

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