Lopinavir Capsules to Kaletra or Invirase Tablets (LoCKIT)
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ClinicalTrials.gov Identifier: NCT00438152 |
Recruitment Status
:
Completed
First Posted
: February 21, 2007
Last Update Posted
: July 18, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Saquinavir (Invirase®) Drug: Lopinavir/ritonavir (Kaletra®) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 53 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | September 2006 |
Actual Primary Completion Date : | February 2009 |
Actual Study Completion Date : | February 2009 |

Arm | Intervention/treatment |
---|---|
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®
|
- 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 ]
- 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. ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00438152
United Kingdom | |
Royal Free Hampstead NHS Trust | |
London, United Kingdom, NW32QG |
Principal Investigator: | Mike S Youle, MD MB ChB | Royal Free Hampstead NHS Trust |
Responsible Party: | Dr. Mike Youle, Royal Free Hampstead NHS Trust |
ClinicalTrials.gov Identifier: | NCT00438152 History of Changes |
Other Study ID Numbers: |
MV20507 |
First Posted: | February 21, 2007 Key Record Dates |
Last Update Posted: | July 18, 2011 |
Last Verified: | February 2007 |
Keywords provided by Royal Free Hampstead NHS Trust:
Lopinavir Saquinavir Lipids HIV-1 Treatment Experienced |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Lopinavir |
Saquinavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |