Study of Protease Inhibitor Regimen Switch in HIV-1 Infec... | NCT00849160

Studies
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

Sponsor

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

Status

Completed

Last Update Posted

Jan 22, 2014Estimated

Enrollment

100Actual

Phase

Phase 3

Conditions

HIV-1 Infection
HIV Infections

Interventions

darunavir

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

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.

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Jun 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Feb 20, 2009

First Submission Date that Met QC Criteria

Feb 20, 2009

First Posted Date

Feb 23, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2014

Last Update Posted Date

Jan 22, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Label	Type	Description	Intervention Names
Darunavir/r	Experimental		Drug: darunavir

Name	Type	Description	Arm Group Labels	Other Names
darunavir	Drug	darunavir/r 800/100 mg once daily by oral route, 48 weeks of treatment	Darunavir/r

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Undetectable viral load ( < 50 copies/ml)		Week 24

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jade Ghosn, MD	Centre Hsopitalier Universitaire de Bicêtre	Principal Investigator
Christine Katlama, MD	Groupe Hospitalier Pitie-Salpetriere	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Universitaire de Bicêtre - Service de Médecine Interne et Maladies Tropicales		Le Kremlin-Bicêtre		94275	France

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D002219	Carbamates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D013450	Sulfones
D013457	Sulfur Compounds
D005663	Furans
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds