Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients
This study has been completed.
Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00648999
First received: March 28, 2008
Last updated: March 14, 2013
Last verified: January 2013
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Purpose
To demonstrate that patients treated with Kaletra have an improvement in their quality of life compared to the quality of life they had with their previous NRTI therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Human Immunodeficiency Virus |
Drug: lopinavir/ritonavir |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase IV, Non Randomized Study in ARV Experienced Patients Under Switch Therapy With Kaletra |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by AbbVie:
Primary Outcome Measures:
- Quality of Life [ Time Frame: Baseline, Week 4, Week 24 and Week 48 ] [ Designated as safety issue: No ]
- CD4 [ Time Frame: Baseline, Week 24 and Week 48 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Adverse Event Monitoring [ Time Frame: Baseline, Week 4, Week 24 and Week 48 ] [ Designated as safety issue: Yes ]
| Enrollment: | 207 |
| Study Start Date: | November 2003 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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:
|
Eligibility| Ages Eligible for Study: | 17 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00648999
Locations
| Mexico | |
| Site Ref # / Investigator 4077 | |
| Mexico City, Distrito Federal, Mexico, 10300 | |
| 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 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 | |
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
| Study Director: | Jose Canadas, MD | AbbVie |
More Information
Additional Information:
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT00648999 History of Changes |
| Other Study ID Numbers: | MEXI-P01-02 |
| Study First Received: | March 28, 2008 |
| Last Updated: | March 14, 2013 |
| Health Authority: | Mexico: Federal Commission for Protection Against Health Risks |
Keywords provided by AbbVie:
|
Kaletra |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases Ritonavir |
Lopinavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013