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

HIV Infection Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00234962
• Other study ID #: PUER-01-001
• Status: Terminated
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: November 19, 2008
• Start date: August 2002
• Est. completion date: February 2007

Study information

• Verified date: November 2008
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

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

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

Drug:
• Lopinavir/Ritonavir

Locations

Country	Name	City	State
United States	Global Medical Information - Abbott	North Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antiviral efficacy by HIV RNA
Secondary	Treatment related discontinuations, predictors of adherence