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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00849160
First Posted: February 23, 2009
Last Update Posted: January 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
February 20, 2009
February 23, 2009
January 22, 2014
May 2009
June 2011   (Final data collection date for primary outcome measure)
Undetectable viral load ( < 50 copies/ml) [ Time Frame: Week 24 ]
Same as current
Complete list of historical versions of study NCT00849160 on ClinicalTrials.gov Archive Site
  • Proportion of patients with undetectable viral load under 50 copies/ml [ Time Frame: All visits ]
  • 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 ]
  • CD4 lymphocytes count and evolution [ Time Frame: All visits ]
  • Lipids balance evolution [ Time Frame: All visits ]
  • Treatment tolerance [ Time Frame: All visits ]
  • Measure of the darunavir/r concentrations variability and correlation with the potential adverse events and/or virologic failures. [ Time Frame: All visits ]
  • Spermatic viral load (sub-study concerning 15 patients) [ Time Frame: Day 0 and Week 48 ]
  • Pharmacologic sub-studies [ Time Frame: All visits ]
Same as current
Not Provided
Not Provided
 
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.
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.

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.

Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • HIV-1 Infection
  • HIV Infections
Drug: darunavir
darunavir/r 800/100 mg once daily by oral route, 48 weeks of treatment
Experimental: Darunavir/r
Intervention: Drug: darunavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
September 2011
June 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00849160
CREPATS 001
No
Not Provided
Not Provided
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
Not Provided
Principal Investigator: Jade Ghosn, MD Centre Hsopitalier Universitaire de Bicêtre
Study Director: Christine Katlama, MD Groupe Hospitalier Pitié-Salpêtrière
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP