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Study of Adherence Effects and Clinical Outcomes of Kaletra Based HIV Antiviral Therapy

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infection

Intervention: Lopinavir/Ritonavir (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Global Medical Information, Study Director, Affiliation: Abbott

Summary

The purpose of this study is to evaluate the effects of adherence on HIV antiviral response to treatment regimens containing Kaletra or other HIV protease inhibitors.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Antiviral efficacy by HIV RNA

Secondary outcome: Treatment related discontinuations, predictors of adherence

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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:

-

Locations and Contacts

Global Medical Information - Abbott, North Chicago, Illinois 60064, United States
Additional Information

Starting date: August 2002
Last updated: November 19, 2008

Page last updated: August 23, 2015

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