Pilot Study Switching Individuals Receiving EFV With Continuing Central Nervous System Toxicity to TMC125
This study has been completed.
Sponsor:
St Stephens Aids Trust
Information provided by:
St Stephens Aids Trust
ClinicalTrials.gov Identifier:
NCT00792324
First received: November 14, 2008
Last updated: November 17, 2009
Last verified: November 2009
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
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 neuropsychiatric 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 ]
| Enrollment: | 24 |
| Study Start Date: | June 2008 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Group 1
Four 100mg Etravirine tablets plus one Efavirenz (EFV) placebo tablet once daily
|
Drug: Etravirine
Four 100mg tablets daily for 12-24 weeks
Other Names:
|
|
Active Comparator: Group 2
One 600mg EFV tablet plus four Etravirine placebo tablet tablets once daily
|
Drug: Efavirenz
One 600mg tablet daily
Other Names:
|
Show Detailed Description 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 treatment 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 practicing 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 practicing 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 judgment 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 enrollment:
- 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 More Information
No publications provided
| Responsible Party: | Dr Mark Nelson, St Stephens Aids Trust |
| ClinicalTrials.gov Identifier: | NCT00792324 History of Changes |
| Other Study ID Numbers: | SSAT 029 |
| Study First Received: | November 14, 2008 |
| Last Updated: | November 17, 2009 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Efavirenz Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 21, 2013