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CompletedNCT00234910KALEADUpdated Jul 10, 2008

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

A Phase 3 interventional study of Tenofovir DF and lopinavir/ritonavir with 2 Nucleoside RTIs in HIV Infection, sponsored by Abbott. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-07-10.

Sponsored by Abbott · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
152
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • HIV Infection

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Keywords

  • Lopinavir
  • Ritonavir
  • Kaletra
  • Tenofovir
  • HIV infection
  • Treatment Naive
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 152 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Abbott is the lead sponsor of 350 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

-

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
152 participants (actual)

Study arms

  • Experimental
    A

    2 drug arm

    Drug: Tenofovir DF · Drug: lopinavir/ritonavir with 2 Nucleoside RTIs

  • Active comparator
    B

    3 drug arm, SOC

    Drug: lopinavir/ritonavir with 2 Nucleoside RTIs

Interventions

  • DrugTenofovir DF

    TDF 300mg QD for 72 wks

  • Druglopinavir/ritonavir with 2 Nucleoside RTIs

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

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

06

What researchers measure

Primary outcomes

  1. Antiviral efficacy by HIV RNA

    Time frame: 72 wks

  2. Incidence of adverse events

    Time frame: 72 wks

Secondary outcomes

  1. Adherence and quality of life

    Time frame: 72 wks

07

Study locations

1 site
  • Global Medical Information-Abbott
    Abbott Park, Illinois 60064, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00234910
Lead sponsor
Abbott
First posted
Oct 10, 2005
Start date
Jan 2005
Primary completion
Jun 2007
Completion
Jun 2008
Last update
Jul 10, 2008

Study contacts

Umberto di Luzio Paparatti, MD
study director · Abbott

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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