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Lopinavir Capsules to Kaletra or Invirase Tablets

Information source: Royal Free Hampstead NHS Trust
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Saquinavir (Invirase®) (Drug); Lopinavir/ritonavir (Kaletra®) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Royal Free Hampstead NHS Trust

Official(s) and/or principal investigator(s):
Mike S Youle, MD MB ChB, Principal Investigator, Affiliation: Royal Free Hampstead NHS Trust

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome:

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.

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.

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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┬Ě

- 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)] ├Ś weight (kg) ├Ś constant 72 ├Ś 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

Locations and Contacts

Royal Free Hampstead NHS Trust, London NW32QG, United Kingdom
Additional Information

Starting date: September 2006
Last updated: July 15, 2011

Page last updated: August 23, 2015

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