Early Access of TMC125 in combination with other antiretrovirals in treatment-experienced HIV-1 infected subjects with limited treatment options.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Subject or Legal Authorized Representative has voluntarily given informed con-
sent before initiation of trial procedures.
2. Subject has documented HIV-1 infection.
3. Male or female subject over 18 years of age.
4. Subject has limited treatment options due to virological failure or intolerance to
multiple ARV regimens.
5. Subject is at least 3-class experienced (3 classes of licensed oral ARVs: N[t]RTIs,
PIs, NNRTIs).
Note: Subjects with primary NNRTI resistance can be included if they are experienced with at least 2 classes of ARVs (PIs, N[t]RTIs) and meet all the other inclusion criteria.
6. Subject has previously received 2 different PI-based regimens.
7. Subject is unable to use currently approved NNRTIs due to resistance (primary or
acquired) and/or intolerance.
8. Subject, if currently receiving an ARV regimen, is not achieving adequate virologic
suppression on his/her current regimen (defined as a confirmed detectable
plasma VL on the current treatment).
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

Exclusion Criteria

1. Primary HIV infection.
2. Prior or current participation in DUET trials (TMC125-C206 or TMC125-C216).
3. Any condition which, in the opinion of the investigator, could compromise the sub-
ject’s safety or adherence to the protocol.
4. Use of disallowed concomitant therapy, including disallowed ARVs.
5. Use of non-ARV investigational medications within the 30 days prior to baseline
visit.
6. Use of investigational ARVs, unless stated as an exception in Section 5.3.8.2.2 of
the protocol.
7. Any active clinically significant disease (e.g., cardiac dysfunction, pancreatitis,
acute viral infection) or findings during screening of medical history or physical
examination that is not either resolved or stabilized for at least 30 days before
the screening phase of the trial.
8. Acute viral hepatitis, including but not restricted to A, B or C.
9. Pregnant or breast-feeding female.
10. Female subject of childbearing potential not using effective non-hormonal birth
control methods or not willing to continue practicing these birth control methods
from screening until the last trial related activity.
Note: Hormone based contraception may not be reliable when taking TMC125; therefore, to be eligible for this trial, women of childbearing potential who may have vaginal intercourse should either:
(1) Use a double barrier method to prevent pregnancy (i.e., use a condom without
spermicide, with either a diaphragm or cervical cap) or
(2) Use hormone based contraceptives in combination with a barrier contraceptive
(i.e., male condom without spermicide, diaphragm or cervical cap or female
condom) or
(3) Use an intrauterine device (IUD) in combination with a barrier contraceptive (i.e.,
male condom without spermicide, diaphragm or cervical cap or female condom) or
Note: The use of an IUD has been associated with an increased rate of sexually
transmitted diseases.
(4) Be non-heterosexually active, practice sexual abstinence or have a vasectomized
partner (confirmed sterile).
Note: Women who are postmenopausal for at least 2 years, women with total
hysterectomy and women with tubal ligation are considered of nonchildbearing
potential.
11. Subjects with the following laboratory abnormalities as defined by a standard-
ized grading scheme based on the Division of AIDS (DAIDS) grading table (up-
dated version from December 2004, see Section 7.2):
- Hemoglobin < 7,4 g/dL (4,5 mmol/L)
- Absolute neutrophil count < 500/mm³ (0,5 x 10 9/l)
- Platelets < 25 000/mm3 (25 000 x 10 9/l)
- Prothrombin time (PT) >1,5 x upper limit of laboratory normal range (ULN)
Note: Subjects on anticoagulant therapy with elevated PT > 1,5 ULN require approval of the sponsor prior to enrollment.
- Alkaline phosphatase > 5 x ULN
- Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) > 5 x ULN
- Bilirubin > 5 x ULN
Note: Subjects with elevated bilirubin > 5xULN assessed as related to a component
of ART therapy may be enrolled with prior approval of the sponsor.
- Lipase > 3 x ULN
- Amylase > 5 x ULN if lipase > 2 x ULN
- Creatinine > 1,8 x ULN
12. Subjects with clinical or laboratory evidence of significantly decreased hepatic
function or decompensation, irrespective of liver enzyme levels.
Note: Subje

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

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