NCT01116817

Brief Summary

The aim of this study is to describe and compare the percentage of patients infected by HIV-1 to maintain a complete virology suppression at the CSF (CSF CV 1 copy / mL) in patients with CV \<50 copies / mL and treated with stable antiretroviral therapy for at least 3 years with LPV / r 400/100 mg twice daily + 2 NRTI.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_4 hiv

Timeline
Completed

Started Aug 2010

Shorter than P25 for phase_4 hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 5, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

December 5, 2019

Status Verified

December 1, 2019

Enrollment Period

10 months

First QC Date

April 30, 2010

Last Update Submit

December 3, 2019

Conditions

HIV

Keywords

Long-term Lopinavir/ritonavir monotherapyneurocognitive performanceultrasensitive CSF-viraemia

Outcome Measures

Primary Outcomes (1)

  • Ultrasensitive HIV-1 RNA in CSF

    week 0

Secondary Outcomes (6)

  • CD4 cell count

    week 0

  • Plasmatic HIV-1 Viral load

    week 0

  • Plasmatic and CSF trough-LPV concentration

    weeks 0

  • Neurocognitive alteration, present when there is a diagnosis of any neurocognitive disorders associated with HIV (HAND).

    week 0

  • Overall deficit ratio (GDS)

    week 0

  • +1 more secondary outcomes

Study Arms (2)

LPV/r monotherapy 400/100 mg twice daily, orally administered

EXPERIMENTAL

LPV/r monotherapy 400/100 mg twice daily, orally administered

Drug: Lumbar puncture (Lopinavir/ritonavir monotherapy)

Lumbar puncture

ACTIVE COMPARATOR

LPV/r 400/100 mg twice daily + 2 NRTI, orally administered.

Drug: Lumbar puncture (HAART: Lopinavir/ritonavir + 2 NRTI)

Interventions

Lumbar puncture (Lopinavir/ritonavir monotherapy)DRUG

Lumbar puncture at week 0

Also known as: NP
LPV/r monotherapy 400/100 mg twice daily, orally administered
Lumbar puncture (HAART: Lopinavir/ritonavir + 2 NRTI)DRUG

Lumbar puncture at week 0

Also known as: NP
Lumbar puncture

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Experimental group:
  • Initiating monotherapy with lopinavir / ritonavir maintaining values of plasma HIV-1 RNA undetectable (cv \<50 copies / mL).
  • Maintain complete virologic suppression (CV \<50 copies / ml) in plasma for at least 3 years in treatment with LPV / r monotherapy. (Or 2 years, if not complied with the expected number of patients with at least 3 years with LPV / r monotherapy).
  • Good adherence to treatment (\> 90%).
  • Signing of informed consent.
  • Control group:
  • Maintain complete virologic suppression (CV \<50 copies / ml) in plasma for at least 3 years in treatment with LPV / r monotherapy. (Or 2 years, if not complied with the expected number of patients with at least 3 years with LPV / r 400/100 mg 2 twice a day + 2 ITIAN).
  • Good adherence to treatment (\> 90%).
  • Signing of informed consent.

You may not qualify if:

  • Pregnancy or breastfeeding.
  • Therapies that include interferon, interleukin-2, cytotoxic chemotherapy or immunosuppressant at baseline.
  • Do not sign the informed consent.
  • Existence of any contraindication to the performance of lumbar puncture.
  • Presence of psychiatric disorders or being in psychopharmacological treatment.
  • Active alcohol consumption (\> 50 g / day) or illicit drugs.
  • Existence current or past opportunistic infection involving CNS functioning alteration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

Location

MeSH Terms

Interventions

Spinal PunctureLopinavirRitonavir

Intervention Hierarchy (Ancestors)

BiopsySpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, NeurologicalPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative TechniquesPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiazolesSulfur CompoundsOrganic ChemicalsAzoles

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2010

First Posted

May 5, 2010

Study Start

August 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

December 5, 2019

Record last verified: 2019-12

Locations

ES(1)