Primary ObjectiveThe primary objective of the trial is to provide continued access to TMC278 for subjects who were randomized andtreated with TMC278 in the Phase IIb (e.g., TMC278-C204 [C204]) or Phase III trials (e.g., TMC278-TiDP6-C209[ECHO] and…
ID
Source
Brief title
Condition
- Immunodeficiency syndromes
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
confer supra
Secondary outcome
confer supra
Background summary
This is a Phase III, open-label, multicenter, roll-over trial to provide
continued access to TMC278 to HIV-1 infected
subjects who were randomized and treated with TMC278 in the Phase IIb (e.g.,
C204) or Phase III trials
(e.g., ECHO [C209] or THRIVE [C215]) and who continue to benefit from their
antiretroviral treatment, according
to the investigator. In addition, information on the long-term safety and
tolerability of oral doses of
TMC278 25 mg q.d. in combination with a background regimen containing 2
N(t)RTIs will be collected. Available
efficacy data will also be collected.
The Final/Withdrawal visit of the Phase IIb or Phase III trial will be the
first visit of this trial. From this visit
onwards, all enrolled subjects will continue to receive TMC278 25 mg q.d. in
combination with a background
regimen of 2 N(t)RTIs until TMC278 is available to subjects in their country
outside of a clinical trial setting, the
subject meets at least one of the withdrawal criteria, or the subject no longer
has clinical benefit from treatment in the
opinion of the investigator, whichever comes first.
Study objective
Primary Objective
The primary objective of the trial is to provide continued access to TMC278 for
subjects who were randomized and
treated with TMC278 in the Phase IIb (e.g., TMC278-C204 [C204]) or Phase III
trials (e.g., TMC278-TiDP6-C209
[ECHO] and TMC278-TiDP6-C215 [THRIVE]).
Secondary Objectives
The secondary objective is to evaluate the long-term safety and tolerability of
TMC278 25 mg q.d. in combination
with a background regimen containing 2 N(t)RTIs. Available efficacy data will
also be collected.
Study design
confer supra
Intervention
Oral tablets of TMC278 25 mg q.d. should be administered together with a meal.
Study burden and risks
For more details, confer informed consent form;
TMC278 has the following adverse events reported: headache, somnolence, nausea,
upper respiratory tract infection, tiredness and sinusbradycardia, dizziness,
constipation, vomiting, nose- and throatinfection, anemia, cough, arthralgia,
back pain, diarrhea and dyspepsia , immune reconstitution syndrome,
alanine-aminotransferase (ALAT) and aspartateaminotransferase (ASAT) increased.
Rash also been reported for TMC278, as for other hiv-medication.
Other ARV-medication as part of the OBR, each have their known adverse events.
Calculated risk for normal blood draw procedure.
Antwerpseweg 15-17
B-2340 Beerse
BE
Antwerpseweg 15-17
B-2340 Beerse
BE
Listed location countries
Age
Inclusion criteria
1. Male or female subjects, aged 18 years or older.
2. Subjects must have signed an informed consent form (ICF) indicating that they are willing to
participate in the trial and understand the purpose and procedures required for the trial.
3. Subjects are HIV-1 infected and were previously randomized to receive TMC278 in a
TMC278 clinical trial and completed the protocol defined treatment period.
4. Subjects continue to benefit from treatment with TMC278 in the opinion of the investigator.
5. Subjects can comply with the current protocol requirements.
6. The subject's general medical condition, in the investigator's opinion, does not interfere with
participation in the trial.
Exclusion criteria
1. Use of disallowed concomitant therapy (see Section 8).
2. Females of childbearing potential* who are pregnant, or without the use of effective birth
control methods, or not willing to continue practicing these birth control methods during the
trial and for at least 1 month after the end of the trial (or after last intake of TMC278).
Effective birth control methods:
(1) male condom in combination with diaphragm or cervical cap or male condom with
spermicide**,
(2) intrauterine device or hormonal contraceptive,
(3) be non-heterosexually active, practice sexual abstinence or have a vasectomized partner,
vasectomy should have been performed more than 6 months prior to trial initiation.
* Women who are postmenopausal for at least 2 years, women with total hysterectomy and
women who have a bilateral tubal ligation are considered of non-childbearing potential.
** a male and female condom should not be used together due to risk of breakage or damage
caused by latex friction.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-021209-18-NL |
| CCMO | NL35065.078.10 |