A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus KALETRA™ in HIV-Infected Patients Switched from a Stable KALETRA™-Based Regimen - Study A

Phase 1

• Conditions: HIV Infection; MedDRA version: 9.1 Level: LLT Classification code 10020161 Term: HIV infection

• Registration Number: EUCTR2007-000783-25-GB
• Lead Sponsor: Merck Sharp & Dohme Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-28
• Study Completion: 2009-04-21
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 340

Inclusion Criteria

1) 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 RNA from documented medical history PCR.
3) Patient has documented HIV RNA PCR <50 copies/mL (or bDNA <75 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, consisting of KALETRA in combinationwith at least 2nRTIs (reverse transcriptase inhibitors), without a change in antiretroviral therapy and with no documentation of HIV RNA =50 copies/mL during this time.

Patients followed with other approved sensitvie assays may be permitted to screen folloiwng approval by the Merck Clinical Monitor.
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.
6) Patient has no clinical evidence of active pulmonary disease.
7) Patient who is of reproductive potential agrees to use an acceptable method of birth control,
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

Exclusion Criteria

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 circumstnace that might confound the results of the study.
6) Patient has a history of alchol or other substance abuse.
7) Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signed informaed consent.
8) Patient has ever used any experiemental 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 treatment in this study. Short courses of corticosteroids (e.g. as for asthma exacerbation)will be allowed.
10) Patient require hemodialysis.
11) patient has significant hypersensitivity or toher 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 function, such as hypoalbuminaemia or porlonged 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