NCT00234910

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 10, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

July 10, 2008

Status Verified

July 1, 2008

Enrollment Period

2.4 years

First QC Date

September 13, 2005

Last Update Submit

July 9, 2008

Conditions

HIV Infection

Keywords

LopinavirRitonavirKaletraTenofovirHIV infectionTreatment Naive

Outcome Measures

Primary Outcomes (2)

  • Antiviral efficacy by HIV RNA

    72 wks

  • Incidence of adverse events

    72 wks

Secondary Outcomes (1)

  • Adherence and quality of life

    72 wks

Study Arms (2)

A

EXPERIMENTAL

2 drug arm

Drug: Tenofovir DFDrug: lopinavir/ritonavir with 2 Nucleoside RTIs

B

ACTIVE COMPARATOR

3 drug arm, SOC

Drug: lopinavir/ritonavir with 2 Nucleoside RTIs

Interventions

Tenofovir DFDRUG

TDF 300mg QD for 72 wks

A
lopinavir/ritonavir with 2 Nucleoside RTIsDRUG

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

Also known as: ABT-378, Kaletra, lopinavir/ritonavir
AB

Eligibility Criteria

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Global Medical Information-Abbott

Abbott Park, Illinois, 60064, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

TenofovirLopinavirRitonavirlopinavir-ritonavir drug combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingThiazolesSulfur CompoundsAzoles

Study Officials

  • Umberto di Luzio Paparatti, MD

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

October 10, 2005

Study Start

January 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2008

Last Updated

July 10, 2008

Record last verified: 2008-07

Locations

US(1)