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. - Full Text View

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

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 III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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:

MedlinePlus related topics: AIDS

Drug Information available for: Darunavir Darunavir ethanolate

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:	October 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Darunavir/r: Experimental	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

Contacts

Contact: Jade Ghosn, MD	+33145213437	jade.ghosn@bct.aphp.fr
Contact: Aziza Chermak, MD	+33142160129	aziza.chermak@psl.aphp.fr

Locations

France
Groupe Hospitalier Pitié-Salpêtrière - Service des Maladies Infectieuses et Tropicales	Recruiting
Paris, France, 75013
Contact: Aziza Chermak, MD +33142160129 aziza.chermak@psl.aphp.fr
Principal Investigator: Marc-Antoine Valantin, MD
Centre Hospitalier Universitaire de Bicêtre - Service de Médecine Interne et Maladies Tropicales	Recruiting
Le Kremlin Bicêtre, France, 94275
Contact: Jade Ghosn, MD +33145213437 jade.ghosn@bct.aphp.fr
Principal Investigator: Jade Ghosn, MD
Groupe Hospitalier Pitié-Salpêtrière - Service de Médecine Interne	Recruiting
Paris, France, 75013
Contact: Anne Simon, MD +33142161093 anne.simon@psl.aphp.fr
Principal Investigator: Anne Simon, MD
Hôpital Tenon - Service des Maladies Infectieuses et Tropicales	Recruiting
Paris, France, 75020
Contact: Laurence Slama, MD laurence.slama@tnn.aphp.fr
Principal Investigator: Laurence Slama, MD
Hôpital Necker Enfants Malades - Service des Maladies Infectieuses et Tropicales	Recruiting
Paris, France, 75015
Contact: Claudine Duvivier, MD claudine.duvivier@nck.aphp.fr

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 ( Dr Jade Ghosn )
Study ID Numbers:	CREPATS 001
Study First Received:	February 20, 2009
Last Updated:	July 11, 2009
ClinicalTrials.gov Identifier:	NCT00849160 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

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

Treatment Experienced

Additional relevant MeSH terms:

Anti-Infective Agents
Communicable Diseases
HIV Protease Inhibitors
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection

Antiviral Agents
Pharmacologic Actions
Darunavir
Immunologic Deficiency Syndromes
Protease Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on February 08, 2010