Condition category
Infections and Infestations
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
13/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr W.F.W. Bierman

ORCID ID

Contact details

VU University Medical Center
Department of Internal Medicine
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)6 5261 8250
w.bierman@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR436

Study information

Scientific title

A randomised controlled trial in human immunodeficiency virus (HIV) positive patients comparing the efficacy of lopinavir/ritonavir monotherapy versus conventional triple therapy

Acronym

MAIMOKA

Study hypothesis

Not provided at time of registration

Ethics approval

Received from the local medical ethics committee

Study design

Multicentre, randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS)

Intervention

Experimental arm:
96 weeks of lopinavir/ritonavir; the normal dose of lopinavir/ritonavir 400/100 mg twice daily (BID) will be increased if necessary, depending on trough lopinavir plasma level.

Control arm:
96 weeks of continuation of pre-inclusion triple therapy (HAART).

Intervention type

Drug

Phase

Not Specified

Drug names

Lopinavir/ritonavir,

Primary outcome measures

Therapy failure, defined as having a viral load of higher than 400 copies per ml on two consecutive moments in time separated by at least four weeks.

Secondary outcome measures

Genotypic resistance of the virus in multiple compartments (plasma, semen, cerebrospinal fluid [CSF]).

Overall trial start date

01/10/2005

Overall trial end date

01/10/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Subject is HIV-1-infected
2. Subject is on a first or second line antiretroviral therapy consisting of either one protease inhibitor (PI) or one non-nucleoside reverse transcriptase inhibitors (NNRTI) and at least two nucleoside reverse transcriptase inhibitors (NRTIs)
3. Subject has a HIV-1 ribonucleic acid (RNA) load less than 50 copies/ml for at least three months
4. Ethylenediaminetetraacetic acid (EDTA) plasma from before initiation of first or second line antiretroviral therapy is available for genotyping
5. Subject is at least 18 and not older than 65 years of age
6. Subject is able and willing to sign the informed consent form prior to screening evaluations

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

240

Participant exclusion criteria

1. Any mutation in the protease at codon 32, 46, 47, 48, 50, 54, 82, 84 or 90 or more than two mutations in the protease at codon 10, 20, 24, 33, 53, 63, 71, 73
2. Any protease inhibitor regimen failure
3. Any of the following mutations in the reverse transcriptase: M41L, D67N, K70R, L210W, T215Y or T215F, K219Q, K219E, or K65R
4. History of sensitivity/idiosyncrasy to lopinavir/ritonavir
5. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion
6. Inability to understand the nature and extent of the trial and the procedures required
7. Pregnant female (as confirmed by a human chorionic gonadotropin [HCG] test performed less than three weeks before the first dose) or breast-feeding female
8. Hepatitis B surface antigen (HBsAg) positive hepatitis B infection
9. Abnormal serum liver enzymes or creatinine, determined as levels being greater than three times upper limit of normal
10. Fasting plasma triglyceride level greater than 3.0 mmol/l (= 265.8 mg/dl) in non-Kaletra containing regimens despite the use of lipid lowering drugs
11. Fasting plasma total cholesterol level greater than 6.2 mmol/l (= 239.9 mg/dl) in non-Kaletra containing regimens despite the use of lipid lowering drugs
12. Concomitant use of medications that interfere with lopinavir pharmacokinetics

Recruitment start date

01/10/2005

Recruitment end date

01/10/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

VU University Medical Center
Amsterdam
1007 MB
Netherlands

Sponsor information

Organisation

Vrije University Medical Centre (VUMC) (The Netherlands)

Sponsor details

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.vumc.nl

Funders

Funder type

Industry

Funder name

Abbott International

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes