Efficacy of Simplified Two Drug Kaletra Regimen vs. Kaletra Triple Drug Standard of Care Regimen in Treatment naïve HIV Infected Patients (KALEAD)
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ClinicalTrials.gov Identifier: NCT00234910 |
Recruitment Status
:
Completed
First Posted
: October 10, 2005
Last Update Posted
: July 10, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infection | Drug: Tenofovir DF Drug: lopinavir/ritonavir with 2 Nucleoside RTIs | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 152 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | January 2005 |
Actual Primary Completion Date : | June 2007 |
Actual Study Completion Date : | June 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: A
2 drug arm
|
Drug: Tenofovir DF
TDF 300mg QD for 72 wks
Drug: lopinavir/ritonavir with 2 Nucleoside RTIs
LPV/rSGC 400/100mg BID + 2 nucleoside RTIs as prescribed by the Investigator for 72 wks
Other Names:
|
Active Comparator: B
3 drug arm, SOC
|
Drug: lopinavir/ritonavir with 2 Nucleoside RTIs
LPV/rSGC 400/100mg BID + 2 nucleoside RTIs as prescribed by the Investigator for 72 wks
Other Names:
|
- Antiviral efficacy by HIV RNA [ Time Frame: 72 wks ]
- Incidence of adverse events [ Time Frame: 72 wks ]
- Adherence and quality of life [ Time Frame: 72 wks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | 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:

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00234910
United States, Illinois | |
Global Medical Information-Abbott | |
Abbott Park, Illinois, United States, 60064 |
Study Director: | Umberto di Luzio Paparatti, MD | Abbott |
Responsible Party: | Dr. Umberto di Luzio Paparatti, Medical Director Abbott Italy, Abbott |
ClinicalTrials.gov Identifier: | NCT00234910 History of Changes |
Other Study ID Numbers: |
ITAL-04-002 EUDRACT 2004-000786-35 KALEAD |
First Posted: | October 10, 2005 Key Record Dates |
Last Update Posted: | July 10, 2008 |
Last Verified: | July 2008 |
Keywords provided by Abbott:
Lopinavir Ritonavir Kaletra |
Tenofovir HIV infection Treatment Naive |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Lopinavir Tenofovir |
HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |