Study of Adherence Effects and Clinical Outcomes of Kaletra Based HIV Antiviral Therapy
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ClinicalTrials.gov Identifier: NCT00234962 |
Recruitment Status
:
Terminated
First Posted
: October 10, 2005
Last Update Posted
: November 21, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infection | Drug: Lopinavir/Ritonavir | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Factors Associated With Adherence in a Cohort of HIV Positive Subjects on a First Time PI Containing HAART Regimen: Observational Study of the Impact of Adherence on Viral Load for a HAART Regimen Containing Kaletra vs Other Selected PI Containing HAART. |
Study Start Date : | August 2002 |
Actual Study Completion Date : | February 2007 |

- Antiviral efficacy by HIV RNA
- Treatment related discontinuations, predictors of adherence

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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:
- Subject is documented HIV positive
- Subject is greater than or equal to 18 years of age.
- Subject currently on a regimen of either NNRTI + 2 Nucleoside Reverse Transcriptase Inhibitors NRTIs), two or three NRTIs who have failed regimen as evidenced by two consecutive viral loads with values over 1,000 copies/mL, the last one within the last three months, or
- Naïve subjects to ARV regimen who are required to begin a PI containing HAART regimen, or
- Subjects who have become intolerant to their current antiretroviral regimen and are required to be changed to a first time PI containing HAART regimen.
- Subject had laboratory testing within the previous three months and the most recent testing demonstrates all of the following: Hemoglobin >8.0 g/dL; Absolute neutrophil count >750 cells/mL; Platelet count >20,000/mL; ALT or AST <3 x Upper Limit of Normal (ULN); Creatinine <1.5 x ULN; Triglycerides <750 mg/dL.
- Subjects have no have evidence of grade III or IV adverse event or laboratory abnormality.
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): NCT00234962
United States, Illinois | |
Global Medical Information - Abbott | |
North Chicago, Illinois, United States, 60064 |
Study Director: | Global Medical Information | Abbott |
ClinicalTrials.gov Identifier: | NCT00234962 History of Changes |
Other Study ID Numbers: |
PUER-01-001 |
First Posted: | October 10, 2005 Key Record Dates |
Last Update Posted: | November 21, 2008 |
Last Verified: | November 2008 |
Keywords provided by Abbott:
HIV Infection HAART Lopinavir |
Ritonavir Treatment Experienced 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 |
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 |