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

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.

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00234962

Enrollment

200

Registered

2005-10-10

Start date

2002-08-31

Completion date

2007-02-28

Last updated

2008-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Keywords

HIV Infection, HAART, Lopinavir, Ritonavir, Treatment Experienced, Treatment Naive

Brief 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.

Interventions

DRUGLopinavir/Ritonavir

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Antiviral efficacy by HIV RNA	—

Secondary

Measure	Time frame
Treatment related discontinuations, predictors of adherence	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026