Lopinavir Capsules to Kaletra or Invirase Tablets

NCT00438152 | Completed Phase 4 DMC

• 1 other identifier: MV20507
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HIV Infections

Keywords

Lopinavir; Saquinavir; Lipids; HIV-1; Treatment Experienced

Outcome Measures

Primary Outcomes (1)

• 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

  24 weeks

Secondary Outcomes (2)

• 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.

  4 weeks, 12 weeks and 24 weeks.

• 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.

  Week 24

Study Arms (2)

Invirase® tablets

ACTIVE COMPARATOR

Drug: Saquinavir (Invirase®)

Kaletra® tablets

ACTIVE COMPARATOR

Drug: Lopinavir/ritonavir (Kaletra®)

Interventions

Saquinavir (Invirase®) DRUG

Saquinavir 1000mg + Ritonavir 100mg Bd for 24 weeks

Also known as: Invirase®

Invirase® tablets

Lopinavir/ritonavir (Kaletra®) DRUG

Lopinavir/ritonavir 400/100 mg BD 24 weeks

Also known as: Kaletra®

Kaletra® tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Free Hampstead NHS Trust: lead
• Roche Pharma AG: collaborator

Study Sites (1)

Royal Free Hampstead NHS Trust

London, NW32QG, United Kingdom

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Saquinavir; Lopinavir; Ritonavir; lopinavir-ritonavir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinolines; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles

Study Officials

• Mike S Youle, MD MB ChB

  Royal Free Hampstead NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 19, 2007
• First Posted: February 21, 2007
• Study Start: September 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: July 18, 2011

Record last verified: 2007-02

Locations

GB (1)