clinical Trials - HIV / AIDS

Integrase Inhibitor Early Access Protocol:

This clinical trial is designed to provide early access to an integrase inhibitor in combination with optimized background antiretroviral therapy in highly treatment-experienced HIV-1 infected patients with limited to no treatment options. After reading the criteria if you are interested in this trial and/or you have additional questions, please call us at (702) 384-9101.

The following criteria are necessary for inclusion into this trial:

Patient is male or female at least 16 years of age.
Patient has limited or no treatment options due to resistance or intolerance to multiple antiretroviral regimens.

Patient has documented resistance to at least 1 drug in each of the 3 classes of licensed oral ART's (NNRTI, NRTI, and PI) 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.

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

The following criteria would exclude a patient from this trial:

Prior or current participation if 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.
Patient required or is anticipated to require any of the prohibited medications noted in the protocol.
Patients with acute hepatitis due to any cause or clinically significant chronic liver disease including but not limited to cirrhosis, ascites, encephalopathy, hypoalbuminemia, prolonged PT/PTT and/or esophageal varices.
Patient has severe renal insufficiency defined as a calculated creatinine clearance at time of Screening <30 mL/min, based on the Cockcroft-Gault equation which is as follows (and 0.85X this value for females):

Clcr (mL/min)=(140-age) x weight (in kg)
72 x serum creatinine (mg/dL)
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.
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.
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.
Patient has significant hypersensitivity or other contraindication to any of the components of the study drug.