A 24-week, randomised, open-label, 2-arm study to compare the tolerability and efficacy of saquinavir tablets with ritonavir versus lopinavir/ritonavir tablets in HIV 1 infected adults switching from Kaletra capsules - LoCKIT Study
- Conditions
- Human Immunodeficiency Virus (HIV) Type-1 infectionMedDRA version: 8.1 Level: LLT Classification code 10020447 Term: Human immunodeficiency virus type I infection with other conditions
- Registration Number
- EUCTR2006-002585-19-GB
- Lead Sponsor
- Royal Free Hampstead NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 130
- Male or non-pregnant, non-nursing females ?18 years of age
- Seropositive for HIV-1
- On an antiretroviral combination of Kaletra® soft gel capsules with 2 nucleoside/nucleotide analogues for at least 6 months
- HIV-1 RNA viral load <50 copies/mL (2 consecutive measurements in the prior 6 months)
- No prior protease inhibitor exposure prior to commencing Kaletra® sof gel capsules.
- Ability and willingness to provide written informed consent and adhere to the study regimen
- Females of childbearing potential must have a documented negative serum or urine pregnancy test at screening/baseline and ensure that 2 reliable forms of contraception are being used, including a barrier method, for the duration of the study and for 90 days after the last dose of study medication.
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
- Previous treatment with a PI based antiretroviral regimen prior to commencing Kaletra® soft gel capsules
- Patients with acute hepatitis B or C infection
- Significant renal dysfunction (creatinine clearance [CrCl] <60 mL/min) and/or hepatic impairment (aspartate aminotransferase/alanine aminotransferase [AST/ALT] >3 X ULN and/or documented liver cirrhosis)
- Any current known clinical or laboratory parameter of ACTG Grade 4. However, asymptomatic Grade 4 abnormalities will be permitted at the discretion of the investigator if deemed clinically appropriate. Abnormalities deemed insignificant by the investigator must be discussed with the sponsor prior to enrollment.
- Evidence of active, untreated opportunistic infection, intercurrent illness, drug toxicity or any other condition such that in the judgment of the investigator the patient would not be able to take or continue a prescribed antiretroviral regimen
- Malignancy requiring chemotherapy or radiotherapy
- Known hypersensitivity to any of the prescribed antiretroviral drugs or formulation components
- Evidence of alcohol and/or drug or substance abuse that in the judgment of the investigator would likely result in the patient being unreliable in fulfilling the conditions of the protocol
- History of psychological illness or conditions that in the judgment of the investigator might interfere with the patient’s ability to understand the requirements of the study
- History of drug nonadherence that in the judgment of the investigator would result in the patient being unreliable in fulfilling the conditions of this protocol
- Patients who had received an investigational new drug within the last 4 weeks
- Currently taking, or anticipate taking during the course of the study, any drug contraindicated with the antiretroviral drugs they have been randomized to receive
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the lipid benefits of saquinavir tablets (Invirase®) with ritonavir versus lopinavir/ritonavir (Kaletra®) tablets in HIV-1 infected adults switching from Kaletra® soft gel capsules ;Primary end point(s): The primary variable is the difference in the change from baseline of fasting LDL cholesterol levels from baseline to week 24 based on an intent-to-treat exposed (ITT/e) analysis.;<br> Secondary Objective: To evaluate the efficacy of saquinavir tablets with ritonavir versus lopinavir/ritonavir tablets in HIV-1 infected adults switching from Kaletra® soft gel capsules.<br><br> To evaluate the additional safety and tolerability (in particular gastro-intestinal adverse events) of saquinavir tablets with ritonavir versus lopinavir/ritonavir tablets in HIV-1 infected adults switching from Kaletra® soft gel capsules<br>
- Secondary Outcome Measures
Name Time Method