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.

NCT00849160 | Completed Phase 3

• 1 other identifier: CREPATS 001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

HIV-1 Infection; HIV Infections

Keywords

Treatment Experienced

Outcome Measures

Primary Outcomes (1)

• Undetectable viral load ( < 50 copies/ml)

  Week 24

Secondary Outcomes (8)

• Proportion of patients with undetectable viral load under 50 copies/ml

  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.

  All visits

• CD4 lymphocytes count and evolution

  All visits

• Lipids balance evolution

  All visits

• Treatment tolerance

  All visits

Study Arms (1)

Darunavir/r

EXPERIMENTAL

Drug: darunavir

Interventions

darunavir DRUG

darunavir/r 800/100 mg once daily by oral route, 48 weeks of treatment

Darunavir/r

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• HIV-2 infected patients
• 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

Sponsors & Collaborators

• Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida: lead

Study Sites (5)

Centre Hospitalier Universitaire de Bicêtre - Service de Médecine Interne et Maladies Tropicales

Le Kremlin-Bicêtre, 94275, France

Location

Groupe Hospitalier Pitié-Salpêtrière - Service de Médecine Interne

Paris, 75013, France

Location

Groupe Hospitalier Pitié-Salpêtrière - Service des Maladies Infectieuses et Tropicales

Paris, 75013, France

Location

Hôpital Necker Enfants Malades - Service des Maladies Infectieuses et Tropicales

Paris, 75015, France

Location

Hôpital Tenon - Service des Maladies Infectieuses et Tropicales

Paris, 75020, France

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Darunavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jade Ghosn, MD

  Centre Hsopitalier Universitaire de Bicêtre

  PRINCIPAL INVESTIGATOR

• Christine Katlama, MD

  Groupe Hospitalier Pitié-Salpêtrière

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2009
• First Posted: February 23, 2009
• Study Start: May 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 22, 2014

Record last verified: 2014-01

Locations

FR (5)