HIV-1 infected patients MedDRA version: 8.1 Level: LLT Classification code 10020161 Term: HIV infection
Conditions
Interventions
Trade Name: Isentress
Product Name: Isentress
Product Code: MK-0518
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Raltegr
Sponsors
Merck & Co, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In patients with document HIV-1 infection: 1. Patient is a male or female at least 16 years of age. 2. Patient has limited or no treatment options due to resistance or intolerance to multiple antiretroviral regimens. •Patient has documented resistance to NNRTIs by either: i. Genotype or phenotype testing OR ii. Clinical failure on an NNRTI containing regimen that in the opinion of the investigator suggests resistance. •Patient has documented resistance to at least 1 drug in the NRTI class and at least 1 drug in the PI class by genotype or phenotype testing. •Intolerance is defined as having had a clinically significant adverse event which in the opinion of the investigator provides a contraindication to the use of any drug in that class. 3. Patient is not achieving adequate virologic suppression on his/her current regimen and at risk of clinical or immunologic progression. Note: Patients who are virologically suppressed but have a significant intolerance to a drug in their regimen may enroll and switch to MK-0518. 4. Patients should be considered clinically stable, in the opinion of the investigator, at the time of entry into the study; i.e., clinical status and all chronic medications, except for antiretroviral agents, should be unchanged for at least 2 weeks prior to the start of treatment in this study. NOTE: Patients on dialysis who are clinically stable are eligible for enrollment. 5. Patient who is of reproductive potential agrees to use an acceptable method of birth control throughout the study. Acceptable method of birth control is defined as intrauterine device (IUD), diaphragm with spermicide, condoms, or abstinence. OR Patient who is not of reproductive potentia1 ; is not sexually active, whose current partner(s) is not of reproductive potential, or whose sexual activity is exclusively homosexual is eligible without requiring the use of contraception. Note: Use of oral or other hormonal contraception is permitted. Because of the potential interactions of hormonal contraceptives with other antiretrovirals in the OBT, another reliable second method of contraception should be used Are the trial subjects under 18? yes 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
Exclusion criteria: 1. Prior or current participation in MK-0518 clinical trial. Note: Patients who have been receiving MK-0518 via other compassionate use/emergency use mechanisms, can be enrolled in this study. 2. Patient requires or is anticipated to require any of the prohibited medications noted in the protocol. 3. Patients with acute hepatitis due to any cause. Patients with chronic hepatitis can be enrolled. Note: Caution should be used if patients with clinically significant chronic liver disease including but not limited to cirrhosis, ascites, encephalopathy, hypoalbuminemia, prologned PT/PTT and /or esophageal varices are enrolled. 4. Patient has a condition (including but not limited to alcohol or other substance abuse) which in the opinion of the investigator would interfere with patient compliance or safety. 5. Female patient is pregnant or breast-feeding, or expecting to conceive or donate eggs during the study. Male patient is planning to impregnate or provide sperm donation during the study. Note: All female patients must have a negative pregnancy test at Treatment Day 1. 6. Inability to obtain signed informed consent from a patient age 18 or older, or when a parent/legal representative has provided consent, the inability to obtain assent from a patient 16 or 17 years of age. Note: If local guidelines permit, consent may be obtained from those patients who are 16 or 17 years of age. 7. Patient has significant hypersensitivity or other contraindication to any of the components of the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This program is designed to provide expanded access to MK-0518 prior to the product’s approval and availability on the market. The safety and tolerability of MK-0518 400 mg b.i.d. for the treatment of HIV-1 infection will be monitored.;Secondary Objective: ; Primary end point(s): The primary analyses of safety will be based upon the All Patients As Treated (APaT) approach which includes all patients who received one or more doses of test drug therapy. All patients who take study medication will be included in the analysis of safety and tolerability. Only those adverse experiences that occur while on study therapy or within 14 days after discontinuation of study therapy will be included in the analysis. For assessment of safety and tolerability, counts and percentages of patients with clinical or laboratory adverse experiences of the following type will be tabulated (1) serious adverse experience, (2) drug-related adverse experiences that result in grade 3 or above laboratory toxicity; (3) drug related adverse experiences that lead to treatment interruption; (4) drug related adverse experiences leading to discontinuation. No formal hypothesis testing will be done. | — |
Countries
Austria, Belgium, Estonia, Finland, Germany, Ireland, Italy, Latvia, Netherlands, Poland, Slovenia, Spain, Sweden
Outcome results
None listed