TMC125 EFV Switch Study - Full Text View

Sponsored by:	St Stephens Aids Trust
Information provided by:	St Stephens Aids Trust
ClinicalTrials.gov Identifier:	NCT00792324

Purpose

The purpose of the study is to examine the effect of switching from an antiretroviral combination that includes efavirenz (Susitiva®), in individuals experiencing efavirenz-related side effects, and replacing this with an investigational HIV medication called Etravirine (TMC125).

The study will primarily investigate the effect of change in medication on your viral load (the levels of the HIV virus in your blood), on immunological parameters (CD4 count), on other safety parameters (such as cholesterol) your side effects and also on your quality of life.

Condition	Intervention	Phase
HIV	Drug: Etravirine Drug: Efavirenz	Phase III

MedlinePlus related topics: AIDS

Drug Information available for: Efavirenz Etravirine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase III, Double Blind, Mulit-Centre, Randomised Placebo Controlled, Pilot Study to Assess the Feasibility of Switching Individuals Receiving Efavirez With Continuing Central Nervous System (CNS) Toxicity to TMC125.

Further study details as provided by St Stephens Aids Trust:

Primary Outcome Measures:

The rate of neuropsychiatric and central nervous system (CNS) toxicity as measured by the proportion of patients experiencing grade 2-4 neuropysychiatric and CNS toxicity after 12 weeks (as defined by the ACTG adverse event scale). [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The rate of neuropsychiatric and central nervous system (CNS) toxicity after 12 and 24 weeks as measured by the change from baseline by the Hospital Anxiety and Depression Scale (HADS). [ Time Frame: 12-24 weeks ] [ Designated as safety issue: Yes ]
Proportion of patients with viral load below 50 copies/mL at weeks 12 and 24 [ Time Frame: 12-24 weeks ] [ Designated as safety issue: No ]
Proportion of patients with viral load below 400 copies/mL at weeks 12 and 24 [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
Change from baseline in CD4+ count at weeks 12 and 24 [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
Change from baseline in laboratory parameters at weeks 12 and 24 [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
Proportion of patients with non-CNS adverse events at weeks 12 and 24 [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
Change from baseline in adherence at weeks 12 and 24 as measured by the adherence questionnaire: Medication Adherence Self- Report Inventory (M-MASRI) [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
Change from baseline in patient-perceived distress associated with tolerability problems at weeks 12 and 24 as determined by tolerability index questionnaire (HIV patients symptoms profile) [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	June 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Four 100mg Etravirine tablets plus one Efavirenz (EFV) placebo tablet once daily	Drug: Etravirine Four 100mg tablets daily for 12-24 weeks
2: Active Comparator One 600mg EFV tablet plus four Etravirine placebo tablet tablets once daily	Drug: Efavirenz One 600mg tablet daily

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Documented HIV-1 infection
Willing to comply with the protocol requirements
Has an HIV-plasma viral load at screening <50 HIV-1 RNA copies/mL
Has a CD4 cell count at screening >50 cells/mm3
Has been on a stable ART, with at least 3 licensed agents, one of which being EFV, for at least 12 weeks at screening, and is willing to stay on treatemnt until baseline
Symptomatic toxicity associated with the EFV after at least 12 weeks of therapy
If subject is female of childbearing potential, she is using effective birth control methods and is willing to continue practising these birth control methods during the trial and for at least 30 days after the end of the trial (or after last intake of investigational ARV's)
If the subject is a heterosexually active male, he is using effective birth control methods and is willing to continue practising these birth control methods during the trial and until 30 days after the end of the trial (or after the last intake of investigational ARVs)

Exclusion Criteria:

Subject has a primary HIV-1 infection
Subject has an HIV-2 infection
Subject is using any concomitant therapy disallowed by the protocol (as per SPC for EFV and TMC125)
Subject has any condition (including but not limited to alcohol and drug use) which, in the opinion of the investigator, could compromise the subject's safety or adherence to the protocol
Subject's life expectancy less than 6 months according to the judgement of the investigator
subject has a currently active AIDS defining illness (Category C conditions according to the Center for Disease Control [CDC] Classification System for HIV Infection 1993) with the following exceptions, which must be discussed with the sponsor prior to enrolment:
Stable cutaneous Kaposi's Sarcoma (i.e., no pulmonary or gastrointestinal involvement other than oral lesions) that is unlikely to require any form of systemic therapy during the trial period
Wasting syndrome due to HIV infection Note: Primary and secondary prophylaxis for an AIDS defining illness is allowed if the medication used is not part of the disallowed medication
Subject has any active clinically significant disease (e.g., pancreatic, cardiac dysfunction) or findings during Screening of medical history or physical examination that, in the investigator's opinion, would compromise the outcome of the trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792324

Contacts

Contact: Mark Nelson	02088465610	mark.nelson@chelwest.nhs.uk
Contact: Carl Fletcher	02088466323	carl.fletcher@chelwest.nhs.uk

Locations

United Kingdom
Chelsea and Westminster Hospital	Recruiting
London, United Kingdom, SW10 9TH
Contact: Mark Nelson 02088465610
Contact: Carl Fletcher 02088466323

Sponsors and Collaborators

St Stephens Aids Trust

Investigators

Principal Investigator:

Mark Nelson

St Stephen's AIDS Trust

More Information

Responsible Party:	St Stephens Aids Trust ( Dr Mark Nelson )
Study ID Numbers:	SSAT 029
Study First Received:	November 14, 2008
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00792324
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Efavirenz
HIV Infections
Acquired Immunodeficiency Syndrome

ClinicalTrials.gov processed this record on January 15, 2009