Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00648999 |
Recruitment Status
:
Completed
First Posted
: April 1, 2008
Last Update Posted
: March 15, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Human Immunodeficiency Virus | Drug: lopinavir/ritonavir | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 207 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase IV, Non Randomized Study in ARV Experienced Patients Under Switch Therapy With Kaletra |
Study Start Date : | November 2003 |
Actual Primary Completion Date : | December 2006 |
Actual Study Completion Date : | December 2006 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1 |
Drug: lopinavir/ritonavir
lopinavir/ritonavir 400 mg/100 mg bid 48 weeks of treatment
Other Names:
|
Active Comparator: 2 |
Drug: lopinavir/ritonavir
lopinavir/ritonavir 400 mg/100 mg bid 48 weeks of treatment
Other Names:
|
- Quality of Life [ Time Frame: Baseline, Week 4, Week 24 and Week 48 ]
- CD4 [ Time Frame: Baseline, Week 24 and Week 48 ]
- Adverse Event Monitoring [ Time Frame: Baseline, Week 4, Week 24 and Week 48 ]

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Ages Eligible for Study: | 17 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV Infected subjects
- Subjects failing in current HIV treatment, or
- Subjects with a viral load < 400 copies/mL and not tolerating their current HIV treatment.
Exclusion Criteria:
- Subject is currently participating in another clinical study or has participated in another clinical study within 30 days prior to screening visit
- Subject is pregnant

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): NCT00648999
Mexico | |
Site Ref # / Investigator 4049 | |
Mexico City, Distrito Federal, Mexico, 01030 | |
Site Ref # / Investigator 4050 | |
Mexico City, Distrito Federal, Mexico, 01120 | |
Site Ref # / Investigator 4051 | |
Mexico City, Distrito Federal, Mexico, 09220 | |
Site Ref # / Investigator 4077 | |
Mexico City, Distrito Federal, Mexico, 10300 | |
Site Ref # / Investigator 4056 | |
Mexico City, Distrito Federal, Mexico | |
Site Ref # / Investigator 4074 | |
Leon, Guanajauto, Mexico | |
Site Ref # / Investigator 4054 | |
Morelia, Michoacan, Mexico | |
Site Ref # / Investigator 4072 | |
Tepic, Nayarit, Mexico | |
Site Ref # / Investigator 4055 | |
Culiacan, Sinaloa, Mexico | |
Site Ref # / Investigator 4075 | |
Merida, Yucatan, Mexico, 97219 | |
Site Ref # / Investigator 4073 | |
Chihuahua, Mexico, 31310 | |
Site Ref # / Investigator 4052 | |
Oaxaca, Mexico | |
Site Ref # / Investigator 4053 | |
Puebla, Mexico, 72570 |
Study Director: | Jose Canadas, MD | AbbVie |
Additional Information:
Responsible Party: | AbbVie (prior sponsor, Abbott) |
ClinicalTrials.gov Identifier: | NCT00648999 History of Changes |
Other Study ID Numbers: |
MEXI-P01-02 |
First Posted: | April 1, 2008 Key Record Dates |
Last Update Posted: | March 15, 2013 |
Last Verified: | January 2013 |
Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Kaletra |
Additional relevant MeSH terms:
Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Ritonavir |
Lopinavir 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 |