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)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
Information provided by:
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
ClinicalTrials.gov Identifier:
NCT00849160
First received: February 20, 2009
Last updated: May 25, 2010
Last verified: May 2010
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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: | Allocation: Non-Randomized 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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
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 ]
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | February 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
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 des Maladies Infectieuses et Tropicales | |
| Paris, France, 75013 | |
| Groupe Hospitalier Pitié-Salpêtrière - Service de Médecine Interne | |
| Paris, France, 75013 | |
| Hôpital Tenon - Service des Maladies Infectieuses et Tropicales | |
| Paris, France, 75020 | |
| Hôpital Necker Enfants Malades - Service des Maladies Infectieuses et Tropicales | |
| Paris, France, 75015 | |
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: | Dr Jade Ghosn, 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: | May 25, 2010 |
| 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:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Protease Inhibitors Darunavir Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions HIV Protease Inhibitors Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013