A Phase III randomized, double-blinded, placebo-controlled trial to investigate the efficacy, tolerability and safety of TMC125 as part of an ART including TMC114/RTV and an investigator-selected OBR in HIV-1 infected subjects with limited to no treatment options. - ND

Conditions: HIV-1 infection
MedDRA version: 6.1Level: PTClassification code 10020161

Registration Number: EUCTR2005-003160-32-IT

Lead Sponsor: TIBOTEC PHARMACEUTICALS LTD.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 600

Inclusion Criteria

Subjects who meet all of the following criteria are eligible for this trial 1. Male or female subjects, aged 18 years or above. 2. Subject has signed the ICF voluntarily. 3. Subject can comply with the protocol requirements. 4. Subject with documented HIV-1 infection. 5. HIV-1 plasma viral load at screening visit above 5000 HIV-1 RNA copies/mL assayed by RNA polymerase chain reaction PCR ultrasensitive specimen procedure Roche Amplicor HIV-1 MonitorTM . 6. On a stable ART for at least 8 weeks at Screening, and willing to stay on that treatment until Baseline. 7. Documented genotypic evidence of resistance to currently available NNRTIs by having at least 1 NNRTI resistance-associated mutation present based upon the the following list, adapted from the IAS-USA 2004 A98G, L100I, K101E/P/Q, K103H/N/S/T, V106A/M, V108I, E138G/K/Q, V179I/F/G, Y181C/I/V, Y188C/H/L, G190A/E/S, P225H, F227C, M230I/L, P236L, K238N/T, Y318F 8 on the virco TYPE HIV-1 at Screening or from prior genotypic analysis, evidence of which should be available in the source documents and enrolment of the subject based on these data needs to be agreed upon by the sponsor. Note treatment with an investigational NNRTI counts as an NNRTI treatment. 8. Subject has 3 or more documented primary PI mutations as listed by the IAS-USA 2004 D30N, L33I/F, M46I/L, G48V, I50V/L, V82A/F/L/T/S, I84A/C/V, L90M 8 on the virco TYPE HIV-1 at Screening or from prior genotypic analysis, evidence of which should be available in the source documents and enrolment of the subject based on these data needs to be agreed upon by the sponsor. 9.General medical condition, in the investigator s opinion, does not interfere with the assessments and the completion of the trial.
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-1 infection. 2. HIV-2 infection. 3. Use of disallowed concomitant therapy 4. 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. Life expectancy less than 6 months according to the judgment of the investigator. 6. Subject has any currently active AIDS defining illness 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. 7. Any active clinically significant disease e.g., pancreatitis, 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. Acute viral hepatitis including but not limited to A, B, or C. 9. Chronic hepatitis B and/or C with aspartate aminotransferase AST and/or alanine aminotransferase ALT lt; 5 x upper limit of normal ULN . 10. Receipt of an investigational drug within 30 days prior to the trial drug administration, with the exceptions of TMC114 and tipranavir, tenofovir, emitricitabine, or Truvada where these are not yet licensed in a participating country. 11. Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medications administered in this trial. 12. Pregnant or breastfeeding female subject. 13. Female subject of childbearing potential not using effective birth control methods or not 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 ARVs ; 14. Heterosexually active male subject not using effective birth control methods or not willing to continue practicing these birth control methods during the trial and until 30 days after the end of the trial or after last intake of investigational ARVs . 15. Any grade 3 or grade 4 toxicity according to the Division of AIDS DAIDS grading scale, 16. Subject with clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels International Normalized Ratio INR lt; 1.5 or albumin gt; 30 g/L or bilirubin lt; 2.5 x ULN . 17. Subjects who previously received treatment with either TMC125, TMC120, or TMC278 in a previous clinical trial.

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