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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:
Information provided by (Responsible Party):
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
ClinicalTrials.gov Identifier:
NCT00849160
First received: February 20, 2009
Last updated: January 21, 2014
Last verified: January 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with undetectable viral load under 50 copies/ml [ Time Frame: All visits ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • CD4 lymphocytes count and evolution [ Time Frame: All visits ] [ Designated as safety issue: No ]
  • Lipids balance evolution [ Time Frame: All visits ] [ Designated as safety issue: No ]
  • Treatment tolerance [ Time Frame: All visits ] [ Designated as safety issue: Yes ]
  • Measure of the darunavir/r concentrations variability and correlation with the potential adverse events and/or virologic failures. [ Time Frame: All visits ] [ Designated as safety issue: No ]
  • Spermatic viral load (sub-study concerning 15 patients) [ Time Frame: Day 0 and Week 48 ] [ Designated as safety issue: No ]
  • Pharmacologic sub-studies [ Time Frame: All visits ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 20, 2009
Last Updated: January 21, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on November 27, 2014