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

Daniel Podzamczer

Status and phase: Completed; Phase 4

Conditions: HIV

Treatments: Drug: Lopinavir/ritonavir 800 mg / 200mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01581853

2011-005981-39 (EudraCT Number)

KMON

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Lopinavir/ritonavir 800 mg / 200mg

Other group

Description:

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

Treatment:

Drug: Lopinavir/ritonavir 800 mg / 200mg