HAART followed by maintenance with monotherapy - Kaletra (MAIMOKA)
| ISRCTN | ISRCTN45284754 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45284754 |
| Protocol serial number | NTR436 |
| Sponsor | Vrije University Medical Centre (VUMC) (The Netherlands) |
| Funder | Abbott International |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 13/10/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr W.F.W. Bierman
Scientific
Scientific
VU University Medical Center
Department of Internal Medicine
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
| Phone | +31 (0)6 5261 8250 |
|---|---|
| w.bierman@vumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A randomised controlled trial in human immunodeficiency virus (HIV) positive patients comparing the efficacy of lopinavir/ritonavir monotherapy versus conventional triple therapy |
| Study acronym | MAIMOKA |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Lopinavir/ritonavir, |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Genotypic resistance of the virus in multiple compartments (plasma, semen, cerebrospinal fluid [CSF]). |
| Completion date | 01/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 240 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 01/10/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU University Medical Center
Amsterdam
1007 MB
Netherlands
1007 MB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
