TMC114-C226: An Early Access Program to Evaluate the Long-term Safety and Tolerability of TMC114 Combined With a Low Dose of Ritonavir (TMC114/r) With Other Antiretrovirals, for HIV-1 Infected Patients Who Have Failed Multiple Antiretroviral Regimens.

HIV Infections Clinical Trial

Official title:

Early Access of TMC114 in Combination With Low-dose Ritonavir (TMC/r)) and Other Antiretrovirals (ARVs) in Highly Treatment Experienced HIV-1 Infected Patients With Limited to no Treatment Options.

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT00245739
• Other study ID #: CR006304
• Secondary ID: TMC114-C226
• Status: Approved for marketing
• Phase: Phase 3
• First received: October 27, 2005
• Last updated: April 10, 2014

Study information

• Verified date: April 2014
• Source: Tibotec Pharmaceuticals, Ireland
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIreland: Irish Agriculture and Food Development Authority
• Study type: Expanded Access

Clinical Trial Summary

The purpose of this study is to provide early access to TMC114 (a protease inhibitor) for HIV-1 infected patients with limited or no treatment options, who have failed multiple antiretroviral (ARV) regimens, and to evaluate the longer-term safety and tolerability of TMC114/r in combination with other antiretrovirals

Description:

This is a program to provide early access to TMC114 (a protease inhibitor) for HIV-1 infected patients, who have failed multiple antiretroviral (ARV) regimens and who are ineligible for participation in any other Tibotec-sponsored HIV trial. Patients need to be at least 3 class experienced (PIs, NRTIs, NtRTIs, NNRTIs or FI), to have previously received 2 different protease inhibitor-based regimens and to not be virologically suppressed on their current regimen. Patients eligible for any other Tibotec sponsored HIV trial but located more than 100 kilometers away from a study site, will be considered eligible for this early access program.

This program will be conducted as an open-label, non-randomized treatment study. Once treatment with TMC114/r in combination with other antiretrovirals (ARVs) has been initiated (baseline visit), patients will follow the recommended visit schedule based on routine clinical care. No other protease inhibitor combinations other than TMC114/r are to be used in this study, except atazanavir (ATV) and indinavir (IDV) may be allowed. Trial medication will be dispensed every 8 weeks. Treatment with TMC114/r will be continued until treatment-limiting toxicity, loss to follow-up, patient's withdrawal, pregnancy, discontinuation of TMC114 development or when TMC114 has become commercially available.

Selected safety and tolerability data, including adverse events will be collected throughout the study. A urine pregnancy test will be repeated at baseline for female patients if more than 4 weeks have passed since the test at screening, and urine pregnancy tests will be performed at all other visits. In addition, data on CD4 count and viral load will be collected over the treatment period according to local standard of care practice, in order to ensure that patients continue to benefit from treatment with TMC114/r. A final/withdrawal visit as well as a post-trial treatment follow-up contact (4 weeks after the final/withdrawal visit) will be performed. Patients will take oral doses of 600 mg of TMC114 twice daily in combination with 100 mg of ritonavir twice daily, in combination with other antiretrovirals.

Other known NCT identifiers

• NCT00613483

Recruitment information / eligibility

• Status: Approved for marketing
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with documented HIV-1 infection

• has limited or no treatment options due to virological failure or intolerance to multiple antiretroviral regimens

• is at least 3 class experienced and has previously received 2 different protease inhibitor-based regimens

• has a CD4 cell count <= 200 cells/mm3

• is not achieving adequate virologic suppression on his/her current regimen and is at risk of clinical or immunologic progression.

Exclusion Criteria:

• Patient has primary HIV-1 infection (unless documented resistance to all currently approved protease inhibitors participated or is currently participating in a trial with TMC114

• Patient used investigational medication within the last 30 days (except for abacavir/lamivudine and tenofovir/emtricitabine fixed dose combinations, and tipranavir)

• Patient suffers from any active clinically significant disease (e.g., cardiac dysfunction, pancreatitis, acute viral infection) or has evidence of active liver disease, liver impairment/dysfunction or cirrhosis irrespective of liver enzyme levels, or has grade 3 or 4 laboratory abnormalities as defined by National Institute of Allergy and Infectious Diseases Division of AIDS (DAIDS) grading scheme

• Female patients that are pregnant or breast-feeding, or of childbearing potential without 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

Study Design

N/A

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• TMC-114
600/100 mg tablets of TMC114/rtv BID until commercial available to the subject

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tibotec Pharmaceuticals, Ireland

Countries where clinical trial is conducted

United States,  Venezuela,  Belgium,  Canada,  Czech Republic,  Denmark,  Germany,  Greece,  Hungary,  Luxembourg,  Malaysia,  Mexico,  Netherlands,  Puerto Rico,  Russian Federation,  Slovenia,  Spain,  Sweden,  Switzerland,  Taiwan,  Thailand,  Turkey,