Switching the Non-nucleoside Reverse Transcriptase Inhibi... | NCT00966329

Studies
Switching the Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) or Protease Inhibitor (PI) to Maraviroc in HIV Subjects

NCT00966329

Sponsor

Germans Trias i Pujol Hospital

Status

Completed

Last Update Posted

Jan 24, 2013Estimated

Enrollment

30Actual

Phase

Phase 4

Conditions

HIV
HIV Infections

Interventions

maraviroc
control group

Countries

Spain

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

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

Oct 2009

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Aug 25, 2009

First Submission Date that Met QC Criteria

Aug 25, 2009

First Posted Date

Aug 26, 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 23, 2013

Last Update Posted Date

Jan 24, 2013Estimated

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

Patients with HIV-1 infection on HAART regimen including 2 NRTI/NtRTIs plus one of the following : 1 PI/ritonavir or ATV/unboosted or 1 NNRTI, will be randomized to switch from the NNRTI/PI to maraviroc (300 mg /12 h) or to continue with the same approach.

Detailed Description

This is a 48 week randomized, prospective, controlled, open-label, proof-of-concept pilot clinical trial.

Patients with HIV-1 infection on HAART regimen including 2 NRTI/NtRTIs plus one of the following : 1 PI/ritonavir (lopinavir/ritonavir, atazanavir/ritonavir, fosamprenavir /ritonavir, tipranavir/ritonavir, darunavir/ritonavir) or ATV/unboosted (in a regimen without tenofovir) or 1 NNRTI (nevirapine or efavirenz).

Patients will be randomized to switch from the NNRTI/PI to maraviroc (300 mg /12 h) or to continue with the same approach.

The primary endpoint would be the percentage of patients who maintain virological suppression at week 48.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
to switch from the NNRTI/PI to maraviroc	Experimental	to switch from the NNRTI/PI to maraviroc	Drug: maraviroc
to continue with the same approach	Active Comparator	to continue with the same approach	Drug: control group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
maraviroc	Drug	HAART regimen including 2 NRTI/NtRTIs plus maraviroc	to switch from the NNRTI/PI to maraviroc

Measure	Description	Time Frame
Viral load		48 weeks

Measure	Description	Time Frame
Time to virological failure		48 weeks
Administration of lipid-lowering drugs		48 weeks
Changes in the SCORE equation

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HIV-1 infected adults (=/+18 years old).
Patient having a diagnosis of HIV infection, on stable HAART including 2 NRTI/NtRTIs plus one of the following: 1 PI/ritonavir or ATV/unboosted or 1 NNRTI.
Undetectable plasma HIV-1 RNA (VL < 50 copies/mL) while on HAART.
Patient having at least one of the following conditions:
- Antiretroviral-related gastrointestinal disturbances, or
- Low patient's satisfaction associated with the current regimen posology (ritonavir use, ritonavir intolerance…), or
- Any toxicity drug related.
Nadir CD4 cell count > 350 cells/mm3.
Absence of resistance mutations in the RT or PR by (TrugeneTM)
Good treatment adherence.
Voluntary written informed consent.

Exclusion Criteria:

Virologic failure to a previous antiretroviral regimen.
Any antiretroviral resistance mutation in a previous resistance test.
Dual/mixed or X4 viruses detected at any time point, including the pre-treatment ES-Trofile test of the PBMC test done before treatment switch.
Acute infections or uncontrolled chronic infection in the 2 months previous to the inclusion.
Pregnancy or fertile women willing to be pregnant.

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

Name	Affiliation	Role
Eugènia Negredo, MD,PhD	Lluita contra la Sida Foundation, HIV Unit	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Germans Trias i Pujol Hospital		Badalona	Barcelona	08916	Spain
Lluita contra la Sida Foundation, HIV Unit, Irsi Caixa Foundation

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23354282	Derived	Bonjoch A, Pou C, Perez-Alvarez N, Bellido R, Casadella M, Puig J, Noguera-Julian M, Clotet B, Negredo E, Paredes R. Switching the third drug of antiretroviral therapy to maraviroc in aviraemic subjects: a pilot, prospective, randomized clinical trial. J Antimicrob Chemother. 2013 Jun;68(6):1382-7. doi: 10.1093/jac/dks539. Epub 2013 Jan 25.

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

ID	Term
D000077592	Maraviroc
D035061	Control Groups

ID	Term
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic