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HAART followed by maintenance with monotherapy-Kaletra (MAIMOKA).


- candidate number1732
- NTR NumberNTR436
- ISRCTNISRCTN45284754
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR27-sep-2005
- Secondary IDsN/A 
- Public TitleHAART followed by maintenance with monotherapy-Kaletra (MAIMOKA).
- Scientific TitleA randomised controlled trial in HIV positive patients comparing the efficacy of lopinavir/ritonavir monotherapy versus conventional triple therapy.
- ACRONYMMAIMOKA
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedHuman immunodeficiency virus (HIV), AIDS
- Inclusion criteria1. Subject is HIV-1-infected; 2. Subject is on a first or second line antiretroviral therapy consisting of either 1 PI or 1 NNRTI and at least 2 NRTI; 3. Subject has a HIV-1 RNA load < 50 copies/ml for at least 3 months; 4. 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.
- Exclusion criteria1. Any mutation in the protease at codon 32, 46, 47, 48, 50, 54, 82, 84 or 90 or more than 2 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 an HCG test performed less than 3 weeks before the first dose) or breast-feeding female; 8. HBsAg positive hepatitis B infection; 9. Abnormal serum liver enzymes or creatinine, determined as levels being > 3 times upper limit of normal; 10. Fasting plasma triglyceride level > 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 > 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 1-okt-2005
- planned closingdate1-okt-2008
- Target number of participants240
- InterventionsExperimental arm: 96 weeks of lopinavir/ritonavir; the normal dose of lopinavir/ritonavir 400/100 mg BID will be increased if necessary, depending on trough lopinavir plasma level; Control arm: 96 weeks of continuation of pre-inclusion triple therapy (HAART)
- Primary outcomeTherapy failure, defined as having a viral load of higher than 400 copies per milliliter on two consecutive moments in time separated by at least 4 weeks.
- Secondary outcomeGenotypic resistance of the virus in multiple compartments (plasma, semen, CSF).
- Timepoints
- Trial web siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIESMD. W.F.W. Bierman
- CONTACT for SCIENTIFIC QUERIESMD. PhD. M.A. Agtmael, van
- Sponsor/Initiator VU University Medical Center, University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
Abbott International
- PublicationsN/A
- Brief summary
- Main changes (audit trail)
- RECORD27-sep-2005 - 9-jun-2008


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