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Completed

NCT Number: NCT01581853

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

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.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital del Mar, Bercelona, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lopinavir/ritonavir 800 mg / 200mg

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

Other names: Kaletra 200/50 mg comprimidos recubiertos con película

Primary outcomes

  1. plasma viral load <40 copies/mL

    Time frame: Week 48

    HIV Plasma Viral Load <40 copies/ml at week 48.

Secondary outcomes

  1. Stability in the plasma levels of Lopinavir/ritonavir during all study visits

    Time frame: Weeks 4, 8, 12, 16, 24, 36 and 48

    Determination of plasma concentrations of the study drug at weeks 4, 8, 12, 16, 24, 36 and 48

  2. Tolerability

    Time frame: Weeks 4, 8, 12, 16, 24, 36 and 48

    Possible Adverse Events will be collected in all study visits and laboratory tests will also be performed in all study visits (weeks 4, 8, 12, 16, 24, 36 and 48)

  3. Adherence

    Time frame: Weeks 4, 8, 12, 16, 24, 36 and 48

    Medication adherence will be evaluated in all the study visits after making a reconciliation of the medication dispensed and returned by the patients

  4. Satisfaction

    Time frame: Weeks 4, 8, 12, 16, 24, 36 and 48

    Patients' satisfaction with the new regimen will be evaluated using a questionnaire (SMAQ)

  5. - Efficacy in CSF

    Time frame: At least 4 weeks on study treatment

    • In a subsample of patients (10) HIV-1 RNA in CSF will be assessed (added as per amendment)

Sponsors and collaborators

Lead sponsor

Daniel Podzamczer

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 20, 2012
Registry last updated
Oct 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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