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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2007-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infection

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

HIV Infection HAART Lopinavir Ritonavir Treatment Experienced Treatment Naive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lopinavir/Ritonavir

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

\-

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Global Medical Information

Role: STUDY_DIRECTOR

Abbott

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Global Medical Information - Abbott

North Chicago, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PUER-01-001

Identifier Type: -

Identifier Source: org_study_id