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Study of Protease Inhibitor Regimen Switch in HIV-1 Infected Patients With Undetectable Viral Load to Prove the Non-inferiority of Once Daily Dose Regimen Versus the Current Twice Daily Regimen to Maintain the Viral Load Under the Limit of Detection. (RADAR)

Primary Purpose

HIV-1 Infection, HIV Infections

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
darunavir
Sponsored by
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV-1 Infection focused on measuring Treatment Experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HIV-1 infected patients
  • Treatment with an association of 3 molecules including two Nucleotidic Reverse Trasncriptase Inhibitors and a ritonavir-boosted protease inhibitor BID, unchanged for at least one month
  • At least two documented undetectable viral loads (under 50 copies/ml) within the last 3 months
  • Naiive from darunavir
  • Free from any opportunistic infection
  • Creatinin < 3N
  • ASAT & ALAT < 5N
  • Haemoglobin > 7 g/dl
  • Platelets > 50 000/mm3
  • Negative pregnancy test for women of childbearing potential and use of a mechanic contraceptive during sexual relationships
  • Signed informed consent

Exclusion Criteria:

  • HIV-2 infected patients
  • Treatment different from the association described in the inclusion criteria (2 NRTIs + 1 PI/r BID)
  • Patients with a documented problem of treatment compliance within the last 12 months
  • Ongoing active treatment against any opportunistic infection or tuberculosis
  • Any critic concomitant condition (alcohol consumption, fatigue) that may jeopardize treatment compliance and/olr tolerance, and interfere with the protocol compliance
  • Any concomitant treatment that may potentialize or inhibit hepatic cyotchrome-based enzymes
  • Patient already treated with darunavir
  • Patient treated with tipranavir, enfuvirtide, raltegravir, etravirine, and/or maraviroc

Sites / Locations

  • Centre Hospitalier Universitaire de Bicêtre - Service de Médecine Interne et Maladies Tropicales
  • Groupe Hospitalier Pitié-Salpêtrière - Service de Médecine Interne
  • Groupe Hospitalier Pitié-Salpêtrière - Service des Maladies Infectieuses et Tropicales
  • Hôpital Necker Enfants Malades - Service des Maladies Infectieuses et Tropicales
  • Hôpital Tenon - Service des Maladies Infectieuses et Tropicales

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Darunavir/r

Arm Description

Outcomes

Primary Outcome Measures

Undetectable viral load ( < 50 copies/ml)

Secondary Outcome Measures

Proportion of patients with undetectable viral load under 50 copies/ml
Proportion of patients in the situation of virologic failure defined as a viral load higher than 50 copies/ml confirmed with a second examen at least two weeks later.
CD4 lymphocytes count and evolution
Lipids balance evolution
Treatment tolerance
Measure of the darunavir/r concentrations variability and correlation with the potential adverse events and/or virologic failures.
Spermatic viral load (sub-study concerning 15 patients)
Pharmacologic sub-studies

Full Information

First Posted
February 20, 2009
Last Updated
January 21, 2014
Sponsor
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
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1. Study Identification

Unique Protocol Identification Number
NCT00849160
Brief Title
Study of Protease Inhibitor Regimen Switch in HIV-1 Infected Patients With Undetectable Viral Load to Prove the Non-inferiority of Once Daily Dose Regimen Versus the Current Twice Daily Regimen to Maintain the Viral Load Under the Limit of Detection.
Acronym
RADAR
Official Title
Non-comparative, Opened Study, Evaluating in HIV-1 Infected Patients With Undetectable Viral Load, Treated by an Antiretroviral Combination Including a Protease Inhibitor Boosted With Ritonavir and Administered by Oral Route Twice a Day, the Substitutability of the Current Protease Inhibitor Regimen by the Association Darunavir/Ritonavir 800/100 mg Once a Day to Maintain the Viral Load Under the 50 Copies/ml Limit of Detection After 24 Weeks of Treatment.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Darunavir boosted with ritonavir (darunavir/r) is a powerful protease inhibitor, able to reduce the viral load in patients infected with multi-resistant HIV strains; In vitro and in vivo studies have shown that the induction of resistance mutations in the protease gene is much more difficult with the association darunavir/r compared to the other ritonavir-boosted protease inhibitors (PI/r), testifying of a significantly higher genetic barrier to resistance. Moreover, the tolerance to darunavir is good, and the pharmacologic profile of this molecule allows a once daily administration with a 800/100 mg dose in patients infected with a wild HIV strain or with a slightly resistant to darunavir/r strain. Thus, we propose to evaluate the efficacy of the darunavir/r association once daily as a substitute to a protease inhibitor regimen administered twice daily in patients with undetectable viral load receiving a tritherapy including a protease inhibitor administered twice daily.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-1 Infection, HIV Infections
Keywords
Treatment Experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Darunavir/r
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
darunavir
Intervention Description
darunavir/r 800/100 mg once daily by oral route, 48 weeks of treatment
Primary Outcome Measure Information:
Title
Undetectable viral load ( < 50 copies/ml)
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Proportion of patients with undetectable viral load under 50 copies/ml
Time Frame
All visits
Title
Proportion of patients in the situation of virologic failure defined as a viral load higher than 50 copies/ml confirmed with a second examen at least two weeks later.
Time Frame
All visits
Title
CD4 lymphocytes count and evolution
Time Frame
All visits
Title
Lipids balance evolution
Time Frame
All visits
Title
Treatment tolerance
Time Frame
All visits
Title
Measure of the darunavir/r concentrations variability and correlation with the potential adverse events and/or virologic failures.
Time Frame
All visits
Title
Spermatic viral load (sub-study concerning 15 patients)
Time Frame
Day 0 and Week 48
Title
Pharmacologic sub-studies
Time Frame
All visits

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV-1 infected patients Treatment with an association of 3 molecules including two Nucleotidic Reverse Trasncriptase Inhibitors and a ritonavir-boosted protease inhibitor BID, unchanged for at least one month At least two documented undetectable viral loads (under 50 copies/ml) within the last 3 months Naiive from darunavir Free from any opportunistic infection Creatinin < 3N ASAT & ALAT < 5N Haemoglobin > 7 g/dl Platelets > 50 000/mm3 Negative pregnancy test for women of childbearing potential and use of a mechanic contraceptive during sexual relationships Signed informed consent Exclusion Criteria: HIV-2 infected patients Treatment different from the association described in the inclusion criteria (2 NRTIs + 1 PI/r BID) Patients with a documented problem of treatment compliance within the last 12 months Ongoing active treatment against any opportunistic infection or tuberculosis Any critic concomitant condition (alcohol consumption, fatigue) that may jeopardize treatment compliance and/olr tolerance, and interfere with the protocol compliance Any concomitant treatment that may potentialize or inhibit hepatic cyotchrome-based enzymes Patient already treated with darunavir Patient treated with tipranavir, enfuvirtide, raltegravir, etravirine, and/or maraviroc
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jade Ghosn, MD
Organizational Affiliation
Centre Hsopitalier Universitaire de Bicêtre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christine Katlama, MD
Organizational Affiliation
Groupe Hospitalier Pitié-Salpêtrière
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Bicêtre - Service de Médecine Interne et Maladies Tropicales
City
Le Kremlin Bicêtre
ZIP/Postal Code
94275
Country
France
Facility Name
Groupe Hospitalier Pitié-Salpêtrière - Service de Médecine Interne
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Groupe Hospitalier Pitié-Salpêtrière - Service des Maladies Infectieuses et Tropicales
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital Necker Enfants Malades - Service des Maladies Infectieuses et Tropicales
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hôpital Tenon - Service des Maladies Infectieuses et Tropicales
City
Paris
ZIP/Postal Code
75020
Country
France

12. IPD Sharing Statement

Learn more about this trial

Study of Protease Inhibitor Regimen Switch in HIV-1 Infected Patients With Undetectable Viral Load to Prove the Non-inferiority of Once Daily Dose Regimen Versus the Current Twice Daily Regimen to Maintain the Viral Load Under the Limit of Detection.

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