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Lopinavir Capsules to Kaletra or Invirase Tablets (LoCKIT)

This study has been completed.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by:
Royal Free Hampstead NHS Trust
ClinicalTrials.gov Identifier:
NCT00438152
First received: February 19, 2007
Last updated: July 15, 2011
Last verified: February 2007

February 19, 2007
July 15, 2011
September 2006
February 2009   (final data collection date for primary outcome measure)
To evaluate the lipid benefits of Invirase® tablets with ritonavir versus Kaletra® tablets in HIV-1 infected adults on an antiretroviral regimen containing Kaletra® with two nucleosides/nucleotides [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
To evaluate the lipid benefits of Invirase® tablets with ritonavir versus Kaletra® tablets in HIV-1 infected adults on an antiretroviral regimen containing Kaletra® with two nucleosides/nucleotides
Complete list of historical versions of study NCT00438152 on ClinicalTrials.gov Archive Site
  • To evaluate the efficacy of Invirase® tablets with ritonavir versus Kaletra® tablets in HIV-1 infected adults on an ARV regimen containing Kaletra® with 2 nucleosides/nucleotides. [ Time Frame: 4 weeks, 12 weeks and 24 weeks. ] [ Designated as safety issue: No ]
  • To evaluate additional safety and tolerability of Invirase® tablets with ritonavir versus Kaletra® tablets in HIV-1 infected adults on an antiretroviral regimen containing Kaletra® with 2 nucleosides/nucleotides. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • To evaluate the efficacy of Invirase® tablets with ritonavir versus Kaletra® tablets in
  • HIV-1 infected adults on an antiretroviral regimen containing Kaletra® with two
  • nucleosides/nucleotides
Not Provided
Not Provided
 
Lopinavir Capsules to Kaletra or Invirase Tablets
A 24-week, Randomized, Open-label, 2-arm Study to Compare the Safety, Efficacy and Tolerability of Invirase® Tablets With Ritonavir Versus Kaletra® Tablets in HIV 1 Infected Adults on a Kaletra® Based Regimen With 2 Nucleosides/Nucleotides

This study will compare the benefit for patients switching from Kaletra® to Invirase® tablets over remaining on Kaletra® (based on randomization), to elicit the lipid benefits inferred in previous studies

This is a prospective, phase IV, multicentre, randomised, open-label, 2-arm, 24-week study. Approximately 130 HIV-1 infected patients on a stable antiretroviral regimen containing Kaletra® with 2 nucleoside/nucleotide analogues will be randomized to 1 of 2 treatment arms: saquinavir with ritonavir 1000/100 mg BID (using Invirase® tablets) or lopinavir/ritonavir 400/100 mg BID (using Kaletra® tablets).Eligibility for enrollment will be determined at a screening visit that will occur within 30 days of the baseline visit. Protocol-defined study assessments will take place at clinic visits at the end of Weeks 4, 12, and 24.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Saquinavir (Invirase®)
    Saquinavir 1000mg + Ritonavir 100mg Bd for 24 weeks
    Other Name: Invirase®
  • Drug: Lopinavir/ritonavir (Kaletra®)
    Lopinavir/ritonavir 400/100 mg BD 24 weeks
    Other Name: Kaletra®
  • Active Comparator: Invirase® tablets
    Intervention: Drug: Saquinavir (Invirase®)
  • Active Comparator: Kaletra® tablets
    Intervention: Drug: Lopinavir/ritonavir (Kaletra®)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
February 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or non-pregnant, non-nursing females >18 years of age
  • Seropositive for HIV-1
  • On an antiretroviral combination of Kaletra® 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) plus screening viral load <50 copies/ml.
  • 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

Exclusion Criteria:

  • Documented virological failure on a protease inhibitor ARV regimen prior to commencing Kaletra® regimen
  • Documented protease mutation (one or more from the following list) prior to commencing Kaletra® regimen:
  • M46I/L/V, I47A/V, G48V/M, I50V, F53L/Y, I54L/M/V/A/T/S, V82A/T/S/F/M/L, I84A/V/C, L90M
  • Patients with acute hepatitis B or C infection
  • Females who are pregnant, breast-feeding, or who plan to become pregnant or breast-feed during the study·
  • 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)

Note: The site will calculate each patient's CrCl using the Cockcroft-Gault formula [28] as shown below:

CrCl = [140 - age (yr)] × weight (kg) × constant 72 × serum creatinine (Cr) (mg/dL) where, constant = 1 for men and 0.85 for women

  • Any current known clinical or laboratory parameter of ACTG Grade 4 (see Appendix 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 non-adherence 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00438152
MV20507
Yes
Dr. Mike Youle, Royal Free Hampstead NHS Trust
Royal Free Hampstead NHS Trust
Roche Pharma AG
Principal Investigator: Mike S Youle, MD MB ChB Royal Free Hampstead NHS Trust
Royal Free Hampstead NHS Trust
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP