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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
  Purpose

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.


Condition Intervention Phase
HIV-1 Infection HIV Infections Drug: darunavir Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida:

Primary Outcome Measures:
  • Undetectable viral load ( < 50 copies/ml) [ Time Frame: Week 24 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 100
Study Start Date: May 2009
Study Completion Date: September 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Darunavir/r Drug: darunavir
darunavir/r 800/100 mg once daily by oral route, 48 weeks of treatment

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00849160


Locations
France
Centre Hospitalier Universitaire de Bicêtre - Service de Médecine Interne et Maladies Tropicales
Le Kremlin Bicêtre, France, 94275
Groupe Hospitalier Pitié-Salpêtrière - Service de Médecine Interne
Paris, France, 75013
Groupe Hospitalier Pitié-Salpêtrière - Service des Maladies Infectieuses et Tropicales
Paris, France, 75013
Hôpital Necker Enfants Malades - Service des Maladies Infectieuses et Tropicales
Paris, France, 75015
Hôpital Tenon - Service des Maladies Infectieuses et Tropicales
Paris, France, 75020
Sponsors and Collaborators
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
Investigators
Principal Investigator: Jade Ghosn, MD Centre Hsopitalier Universitaire de Bicêtre
Study Director: Christine Katlama, MD Groupe Hospitalier Pitié-Salpêtrière
  More Information

Responsible Party: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
ClinicalTrials.gov Identifier: NCT00849160     History of Changes
Other Study ID Numbers: CREPATS 001
First Submitted: February 20, 2009
First Posted: February 23, 2009
Last Update Posted: January 22, 2014
Last Verified: January 2014

Keywords provided by Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida:
Treatment Experienced

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Darunavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents