A multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 vs KALETRA in HIV-infected Patients Switched from a Stable KALETRA-Based Regimen - Study A - ND
- Conditions
- HIV infectionMedDRA version: 6.1Level: PTClassification code 10000807
- Registration Number
- EUCTR2007-000783-25-IT
- Lead Sponsor
- MERCK SHARP DOHME
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 340
.Patient is a male or female at least 18 years of age on the day of signing the informed consent.
2.Patient is HIV positive as determined by enzyme-linked immunosorbent assay (ELISA) or HIV PCR.
3.Patient has documented HIV RNA <50 copies/mL for at least 3 months prior to study entry while on a KALETRA (dosed as 400 mg lopinavir/100 mg ritonavir twice daily) based regimen without a change in antiretroviral therapy and with no documentation of HIV RNA >=50 copies/mL during this time.
4.Patient has no history of coronary artery disease.
5.Patient has the following laboratory values within 35 days prior to the treatment phase of this study:
a.Alkaline phosphatase <= 5.0 x upper limit of normal
b.AST (SGOT) and ALT (SGPT) <= 5.0 x upper limit of normal. Patients with chronic Hepatitis B and/or C coinfection may be enrolled provided the patients are stable and meet all eligibility criteria.
Note: A single repeat of a laboratory screening test will be allowed for test results that are unexpected based on documented prior laboratory results.
6.Patient has no clinical evidence of active pulmonary disease; at investigator discretion a chest x-ray could be obtained if felt necessary.
7.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. Oral contraceptives are not recommended for this study because contraceptive steroid concentrations may be altered when KALETRA is co-administered with oral contraceptives or with the contraceptive patch.OR
Patient who is not of reproductive potential ; is not sexually active, whose current partner(s) is/are not of reproductive potential, or whose sexual activity is exclusively homosexual is eligible without requiring the use of contraception.
8.Patient agrees to remain off prohibited concomitant medications as outlined in Section 3.2.1 of the protocol.
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
1.Patient is receiving a KALETRA based regimen that includes Stavudine (d4T) as a component of the background antiretroviral therapy.
2.Patient is receiving a KALETRA based regimen that includes a second protease inhibitor in addition to KALETRA.
3.Patient is currently receiving, or has received in the past twelve weeks, agents known to have an effect on lipid levels (for example: fish oils, lipidol, bile-acid sequestrants, HMG-CoA reductase inhibitors [such as simvastatin, atorvastatin, rosuvastatin], ezetimibe, ezetimibe/simvastatin, fibrates, niacin, plant sterols, and/or red yeast).
4.Patient has a medical history which includes diabetes mellitus.
5.Patient has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the patient?s participation for the full duration of the study, such that it is not in the best interest of the patient to participate.
6.Patient has a history of alcohol or other substance abuse which in the opinion of the investigator would interfere with patient compliance or safety.
7.Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent.
8.Patient has ever used any experimental HIV-integrase inhibitor.
9.Patient has used systemic immunosuppressive therapy (e.g., 20 mg or more of prednisone or equivalent per day) within one month prior to treatment in this study. Short courses of corticosteroids (e.g., as for asthma exacerbation) will be allowed.
10.Patient requires hemodialysis.
11.Patient has significant hypersensitivity or other contraindication to any of the components of the study drugs.
12.Patient has chronic hepatitis, including chronic hepatitis B and/or C, with unstable liver function tests. This includes patients who, in the opinion of the investigator, have evidence of impairment of hepatic synthetic function, such as hypoalbuminemia or prolonged PT and PTT.
13.Patient is pregnant or breastfeeding, or expecting to conceive (within the duration of the study). Patient is expecting to donate eggs (within the duration of the study). Patient is expecting to donate sperm (within the duration of the study).
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