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

Abbott

Status and phase: Completed; Phase 3

Conditions: HIV Infection

Treatments: Drug: lopinavir/ritonavir with 2 Nucleoside RTIs; Drug: Tenofovir DF

Study type: Interventional

Funder types: Industry

Identifiers

NCT00234910

KALEAD

ITAL-04-002

EUDRACT 2004-000786-35

Details and patient eligibility

About

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.

Enrollment: 152 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

152 participants in 2 patient groups

A

Experimental group

Description:

2 drug arm

Treatment:

Drug: lopinavir/ritonavir with 2 Nucleoside RTIs

Drug: Tenofovir DF

B

Active Comparator group

Description:

3 drug arm, SOC

Treatment:

Drug: lopinavir/ritonavir with 2 Nucleoside RTIs