NCT00994344

Brief Summary

The purpose of this study is to determine the non-inferiority in the efficacy of DRV/r (900/100 mg) monotherapy at 48 weeks versus LPV/r (400/100 mg) as simplification strategy in subjects with sustained viral suppression on stable PI or NNRTI-antiretroviral regimens.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for phase_4 hiv-infections

Timeline
Completed

Started Oct 2009

Typical duration for phase_4 hiv-infections

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

October 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

February 13, 2014

Status Verified

February 1, 2014

Enrollment Period

3 years

First QC Date

October 13, 2009

Last Update Submit

February 12, 2014

Conditions

HIV Infections

Keywords

DarunavirLopinavirMonotherapyAntiretroviral simplification strategyHIVTreatment experienced

Outcome Measures

Primary Outcomes (1)

  • Plasmatic HIV-1 Viral load

    week 48

Secondary Outcomes (11)

  • CD4 cell count

    baseline, weeks 12, 24, 36, 48

  • Changes in liver enzymes (aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma GT, alkaline phosphatase)

    baseline, weeks 12, 24, 36, 48

  • Changes in total bilirubin

    baseline, weeks 12, 24, 36, 48

  • Changes in lipid parameters (total, HDL-, LDL-, cholesterol, triglycerides)

    baseline, weeks 12, 24, 36, 48

  • Administration of lipid-lowering drugs throughout the study (new administrations or the withdrawal of previous lipid-lowering drugs)

    baseline, weeks 4, 12, 24, 36, 48.

  • +6 more secondary outcomes

Study Arms (2)

Darunavir/ritonavir

EXPERIMENTAL

to switch from the triple therapy based regimens to Darunavir/ritonavir

Drug: Darunavir/ritonavir

Lopinavir/ritonavir

ACTIVE COMPARATOR

to switch from the triple therapy based regimens to Lopinavir/ritonavir

Drug: Lopinavir/ritonavir

Interventions

Darunavir/ritonavirDRUG

Darunavir/ritonavir 800/100 mg once daily

Also known as: N/P
Darunavir/ritonavir
Lopinavir/ritonavirDRUG

Lopinavir/ritonavir 400/100 mg twice daily

Also known as: N/P
Lopinavir/ritonavir

Eligibility Criteria

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

You may qualify if:

  • HIV-1 infected adults (=/+18 years old).
  • Patients having a diagnosis of HIV infection, on stable HAART including:
  • NRTI/NtRTIs plus one of the following : 1 PI/ritonavir (lopinavir/ritonavir, atazanavir/ritonavir, fosamprenavir /ritonavir, tipranavir/ritonavir, darunavir/ritonavir) or ATV/unboosted (in a regimen without tenofovir) 1 NNRTI (nevirapine or efavirenz), raltegravir or maraviroc
  • Undetectable plasma HIV-1 RNA (VL \< 50 copies/mL) while on HAART during at least 3 month prior to switching.
  • Nadir CD4 cell count \> 100 cells/mm3.
  • Absence of major PI-resistance mutations in HIV-protease (IAS 2008).20 Good treatment adherence.
  • Voluntary written informed consent.
  • Patients and physician's preference to change the current HAART regimen for reasons of simplification and/or toxicity.

You may not qualify if:

  • History of virological failure to a previous antiretroviral protease-containing regimens.
  • History of virological failure defined as two consecutive plasma HIV-1 RNA \> 50 copies/mL while on current antiretroviral therapy
  • Breastfeeding, pregnancy or fertile women willing to be pregnant.
  • Patients co-infected with hepatitis B.
  • Concomitant use of any drug with potential drug-drug interaction with DRV/r or LPV/r at study entry.
  • Therapies including interferon, interleukin-2, cytotoxic chemotherapy or immunosuppressors at study entry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Canary Islands, 38320, Spain

Location

MeSH Terms

Conditions

HIV Infections

Interventions

DarunavirRitonavirLopinavir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsCarbamatesAcids, AcyclicCarboxylic AcidsSulfonesSulfur CompoundsFuransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiazolesAzolesPyrimidinonesPyrimidines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Bonaventura Clotet

Study Record Dates

First Submitted

October 13, 2009

First Posted

October 14, 2009

Study Start

October 1, 2009

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

February 13, 2014

Record last verified: 2014-02

Locations

ES(2)