Pilot Simplification Study to Lopinavir/Ritonavir 800/200 mg Monotherapy Regimen Once Daily

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-07-31

Brief Summary

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

Lopinavir/ritonavir monotherapy is currently a well known and widely used strategy, while Lopinavir/ritonavir 800/200 mg once a day in a triple-therapy was approved a few years ago. The purpose of this study is to evaluate efficacy and safety of Lopinavir/ritonavir 800/200 mg monotherapy once a day.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Study to Evaluate the Efficacy and Safety of Lopinavir/Ritonavir Monotherapy Versus Darunavir/Ritonavir Monotherapies as Simplification Switching Strategies of PI/NNRTI-Triple Therapy Based-Regimens

NCT00994344

HIV Infections

COMPLETED PHASE4

Treatment Simplification by Darunavir/Ritonavir 800/100 mg Once a Day Versus a Triple Combination Therapy With Darunavir/Ritonavir

NCT00458302

HIV Infections AIDS Virus Human Immunodeficiency Virus +1 more

COMPLETED PHASE3

Comparison of Treatment Simplification by LPV/r vs Current Treatment Continuation in HIV-Infected Patients

NCT00140751

HIV Infections

COMPLETED PHASE3

Study to Evaluate the Activity and Tolerability of Lopinavir/Ritonavir and Lamivudine Bitherapy in HIV Patients With Viral Suppression

NCT01471821

HIV Infection

COMPLETED PHASE4

Saquinavir/Ritonavir in Single Therapy as Maintenance Treatment

NCT00379405

HIV Infections

COMPLETED PHASE4

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

Study Design

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

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lopinavir/ritonavir 800 mg / 200mg

Kaletra 200/50 mg comprimidos recubiertos con película Lopinavir/ritonavir 800 mg / 200mg will be changed from its approved posology (2 times daily)to once daily in patients with undetectable viral load and in stable treatment with Lopinavir/ritonavir 800 mg / 200mg in monotherapy for at least 6 months

Group Type OTHER

Lopinavir/ritonavir 800 mg / 200mg

Intervention Type DRUG

Lopinavir/ritonavir 800 mg / 200mg will be change from its approved posology (2 times daily)to once daily in patients with undetectable viral load and in stable treatment with Lopinavir/ritonavir 800 mg / 200mg in monotherapy for at least 6 months

Interventions

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

Lopinavir/ritonavir 800 mg / 200mg

Lopinavir/ritonavir 800 mg / 200mg will be change from its approved posology (2 times daily)to once daily in patients with undetectable viral load and in stable treatment with Lopinavir/ritonavir 800 mg / 200mg in monotherapy for at least 6 months

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Kaletra 200/50 mg comprimidos recubiertos con película

Eligibility Criteria

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

Inclusion Criteria

* Patients older than 18, HIV positive
* Patients receiving a monotherapy regimen (Lopinavir/ritonavir twice daily)during the last 6 months
* Undetectable viral load (\<40 copies/ml) during the last 6 months
* Patients that accept participation in the study and sign the Informed Consent Form
* Childbearing females with negative pregnancy tests and using appropriate contraceptive measures

Exclusion Criteria

* Opportunistic disease, cancer or any other active disease with specific treatment
* Active addiction to illegal drugs or active use of psychotropic drugs
* Mental retardation diagnosis, or mental dementia or severe psychiatric disorder (excluding major depression disorder solved \> 3 months)
* Females who are breastfeeding or pregnant

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No