A phase III, double blind, multi centre, randomised placebo controlled, pilot study to assess the feasibility of switching individuals receiving efavirenz with continuing Central Nervous System (CNS) toxicity to TMC125 - Efavirenz taxicity switch to etravirine study
- Conditions
- HIV
- Registration Number
- EUCTR2008-000674-20-GB
- Lead Sponsor
- St Stephen's Aids Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
Subjects who meet all of the following criteria are eligible for this trial:
1.The subject is male or female aged 18 years or above
2.The subject has a documented HIV-1 infection
3.The subject has signed the Informed Consent Form voluntarily
4.The subject is willing to comply with the protocol requirements
5.The subject has an HIV-plasma viral load at Screening <50 HIV-1 RNA copies/mL
6.The subject has a CD4 cell count at Screening >50 cells/mm3
7.The subject 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
8.Symptomatic toxicity associated with the EFV after at least 12 weeks of therapy
9.If the subject is female and 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 ARVs);
Note: Hormone-based contraception may not be reliable when taking investigational agents; therefore, to be eligible for this trial, women of childbearing potential should either:
?Use a double barrier method to prevent pregnancy (i.e., using a condom with either spermicidal cream/foam/gel or diaphragm or cervical cap);
OR
?Use hormone-based contraceptive in combination with a barrier contraceptive (i.e. male condom, diaphragm, or cervical cap with spermicide),
OR
?Use an intrauterine device (IUD) in combination with a barrier contraceptive (i.e., male condom, diaphragm, or cervical cap with spermicide),
OR
?Not engage in heterosexual sex, or have a vasectomised partner with confirmed sterility
Note: Women who are postmenopausal for least 2 years, women with total hysterectomy, and women who have a tubal ligation are considered of non-childbearing potential
Note: Spermicides containing non-oxynol-9 should not be used as this can potentially increase the rate of HIV-1 transmission
Note: Use of an IUD can increase the risk of sexually transmitted infections, including HIV
10.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 last intake of investigational ARVs)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Subjects meeting 1 or more of the following criteria cannot be selected:
1.The subject has a primary HIV-1 infection
2.The subject has an HIV-2 infection
3.The subject is using any concomitant therapy disallowed by the protocol (as per SPC for EFV and TMC125)
4.The 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
5.The subject’s life expectancy less than 6 months according to the judgement of the investigator
6.The 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
7.The 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
8.The subject has acute viral hepatitis including but not limited to A, B, or C
9.The subject has chronic hepatitis B and/or C with aspartate aminiotransferease (AST) and/or alanine aminotransferease (ALT) >5 x upper limit of normal (ULN)
Note: Subjects co-infected with chronic hepatitis B or C will be allowed to enter the trial if their condition is clinically stable and is not expected to require treatment during the trial period. Please refer to the package insert with respect to proper care if hepatitis B co-infection in case tenofovir, lamivudine and/or emtricitabine are included in the OBR
10.The subject has received an investigational drug within 30 days prior to the trial drug administration
11.The subject has previously demonstrated a clinically significant allergy or hypersensitivity to any of the excipients of the investigational medications administered in this trial.
12.If the subject is female, she is pregnant or breastfeeding
13.The subject has any grade 3 or grade 4 toxicity according to Division of AIDS (DAIDS) grading scale, except for:
?Grade 3 glucose elevation;
?Asymptomatic grade 3 pancreatic amylase elevation;
?Asymptomatic grade 3 triglyceride/cholesterol elevation;
?Asymptomatic grade 4 triglyceride elevation
Note: Retesting of abnormal screening values that lead to exclusion will be allowed using any visits during the screening period (to reassess eligibility).
14.The subject has clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (International Normalized Ratio [INR] > 1.5 or albumin < 30g/L or bilirubin > 2.5 x ULN)
Note: Subject can be included if elevated bilirubin is assessed at the time of screening as related to an administered ARV and not related to liver disease.
15.The subject has previously received treatment with either TMC125, TMC120, or TMC278 in a previous clinical trial
16.The subject has reported a resolution of their CNS toxicity between Screening and Baseline visits
17.The subject has a
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method