Overview

Lopinavir Capsules to Kaletra or Invirase Tablets

Status:
Completed
Trial end date:
2009-02-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Royal Free Hampstead NHS Trust
Collaborator:
Roche Pharma AG
Treatments:
Lopinavir
Ritonavir
Saquinavir
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