Human Immunodeficiency Virus (HIV) Type-1 infection MedDRA version: 8.1 Level: LLT Classification code 10020447 Term: Human immunodeficiency virus type I infection with other conditions
Conditions
Interventions
Trade Name: Invirase
Pharmaceutical Form: Coated tablet
Trade Name: Kaletra
Pharmaceutical Form: Tablet
Sponsors
Royal Free Hampstead NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - 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] 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.; 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. 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 | — |
Countries
United Kingdom
Outcome results
None listed