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

A Phase III, Open Label, Randomized, Comparative Study of the Antiviral Efficacy of ARV Therapy With Lopinavir/Ritonavir (LPV/r-Kaletra) in Combination With Tenofovir (TDF) Versus Standard of Care (Kaletra in Combination With 2 Nucleoside RTIs) in naïve-HIV-1 Positive Patients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00234910

Acronym

KALEAD

Enrollment

152

Registered

2005-10-10

Start date

2005-01-31

Completion date

2008-06-30

Last updated

2008-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Keywords

Lopinavir, Ritonavir, Kaletra, Tenofovir, HIV infection, Treatment Naive

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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Antiviral efficacy by HIV RNA	72 wks
Incidence of adverse events	72 wks

Secondary

Measure	Time frame
Adherence and quality of life	72 wks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026