Trial record 15 of 32 for:    " February 02, 2007":" March 02, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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
  Purpose

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


Condition Intervention Phase
HIV Infections
Drug: Saquinavir (Invirase®)
Drug: Lopinavir/ritonavir (Kaletra®)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Royal Free Hampstead NHS Trust:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 53
Study Start Date: September 2006
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Invirase® tablets Drug: Saquinavir (Invirase®)
Saquinavir 1000mg + Ritonavir 100mg Bd for 24 weeks
Other Name: Invirase®
Active Comparator: Kaletra® tablets Drug: Lopinavir/ritonavir (Kaletra®)
Lopinavir/ritonavir 400/100 mg BD 24 weeks
Other Name: Kaletra®

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00438152

Locations
United Kingdom
Royal Free Hampstead NHS Trust
London, United Kingdom, NW32QG
Sponsors and Collaborators
Royal Free Hampstead NHS Trust
Roche Pharma AG
Investigators
Principal Investigator: Mike S Youle, MD MB ChB Royal Free Hampstead NHS Trust
  More Information

No publications provided

Responsible Party: Dr. Mike Youle, Royal Free Hampstead NHS Trust
ClinicalTrials.gov Identifier: NCT00438152     History of Changes
Other Study ID Numbers: MV20507
Study First Received: February 19, 2007
Last Updated: July 15, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Royal Free Hampstead NHS Trust:
Lopinavir
Saquinavir
Lipids
HIV-1
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Saquinavir
Ritonavir
Lopinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014