Unspecified human immuno-deficiency virus [HIV] disease MedDRA version: 9.1 Level: LLT Classification code 10020160 Term: HIV disease
Conditions
Interventions
Product Name: MK-0518
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Tablet
Route of administr
Sponsors
Merck & Co. Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Patient is a male or female at least 16 years of age. b. Patient has screening plasma HIV RNA (determined by the central laboratory) >1000 copies/mL within 60 days prior to the treatment phase of this study. c. Patient is ART experienced and on stable ART for =2 months prior to screening. d. Patient has HIV with documented reduced susceptibility to at least one drug in each of the 3 classes of licensed oral ARTs (NNRTI + NRTI + PI) as per genotypic/phenotypic resistance report from the central laboratory used for this protocol. In cases where the central laboratory resistance sample fails or results are not consistent with prior resistance history, patients may be allowed to enroll based on prior resistance results and ART regimen history, after discussion with the Merck Medical Monitor. 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: a. Patient has used another experimental HIV-integrase inhibitor. b. Patient requires or is anticipated to require any of the prohibited medications noted in the protocol. c. Patient has a current (active) diagnosis of acute hepatitis due to any cause or chronic hepatitis other than stable chronic Hepatitis B and/or C. d. Patient has any condition or prestudy laboratory abnormality, or history of any illness, which, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs to the patient. e. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Safety, tolerability and proportion of patients achieving HIV RNA 1000 copies/mL and documented resistance to at least 1 drug in each of the 3 classes of licensed oral antiretrovirals (ARTs) (Nucleoside Reverse Transcriptase Inhibitors [NRTIs], Non-Nucleoside Reverse Transcriptase Inhibitors [NNRTIs], and Protease Inhibitors [PIs]): (1) Evaluate the antiretroviral activity of MK-0518 400 mg b.i.d. compared to placebo, both in combination with Optimized Background Therapy (OBT), as measured by proportion of patients achieving HIV RNA <400 copies/mL at Week 16. (2) Evaluate the safety and tolerability of MK-0518 400 mg b.i.d. compared to placebo, both in combination with OBT, assessed by review of the accumulated safety data. ;Secondary Objective: (1) Evaluate the antiretroviral activity of MK-0518 400 mg b.i.d. compared to placebo, both in combination with OBT, as measured by the following parameters at Week 16: (a) Proportion of patients with virologic response at Week 16; (b) Change from baseline in HIV RNA (log10 copies/mL); (c) Change from baseline in CD4 cell count. (2) Evaluate the antiretroviral activity of MK-0518 400 mg b.i.d. in combination with OBT at Week 48. | — |
Countries
Denmark, Germany, Italy, Portugal, Spain
Outcome results
None listed