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NCT00234910 Clinical Trial

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

HIV Infection Clinical Trial

— KALEAD  

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00234910
Other study ID # ITAL-04-002
Secondary ID EUDRACT 2004-000
Status Completed
Phase Phase 3
First received September 13, 2005
Last updated July 9, 2008
Start date January 2005
Est. completion date June 2008

Study information
Verified date July 2008
Source Abbott
Contact n/a
Is FDA regulated No
Health authority Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 152
Est. completion date June 2008
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Tenofovir DF
TDF 300mg QD for 72 wks
• lopinavir/ritonavir with 2 Nucleoside RTIs
LPV/rSGC 400/100mg BID + 2 nucleoside RTIs as prescribed by the Investigator for 72 wks

Locations
Country Name City State
United States Global Medical Information-Abbott Abbott Park Illinois

Sponsors (1)
Lead Sponsor Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Antiviral efficacy by HIV RNA 72 wks No
Primary Incidence of adverse events 72 wks Yes
Secondary Adherence and quality of life 72 wks No
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