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Efficacy of Simplified Two Drug Kaletra Regimen vs. Kaletra Triple Drug Standard of Care Regimen in Treatment naïve HIV Infected Patients (KALEAD)
This study has been completed.
Sponsor:
Abbott
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00234910
First received: September 13, 2005
Last updated: July 9, 2008
Last verified: July 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| HIV Infection | Drug: Tenofovir DF Drug: lopinavir/ritonavir with 2 Nucleoside RTIs | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Abbott:
Primary Outcome Measures:
- Antiviral efficacy by HIV RNA [ Time Frame: 72 wks ]
- Incidence of adverse events [ Time Frame: 72 wks ]
Secondary Outcome Measures:
- Adherence and quality of life [ Time Frame: 72 wks ]
| Enrollment: | 152 |
| Study Start Date: | January 2005 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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:
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00234910
Please refer to this study by its ClinicalTrials.gov identifier: NCT00234910
Locations
| United States, Illinois | |
| Global Medical Information-Abbott | |
| Abbott Park, Illinois, United States, 60064 | |
Sponsors and Collaborators
Abbott
Investigators
| Study Director: | Umberto di Luzio Paparatti, MD | Abbott |
More Information
| 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 |
| Study First Received: | September 13, 2005 |
| Last Updated: | July 9, 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 |
ClinicalTrials.gov processed this record on July 21, 2017