HAART followed by maintenance with monotherapy-Kaletra (MAIMOKA).
- Conditions
- HIV/AIDS
- Registration Number
- NL-OMON20599
- Lead Sponsor
- VU Medical CenterandUniversity Medical Center Utrecht
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 240
1. 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.
1. 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Therapy 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 Outcome Measures
Name Time Method Genotypic resistance of the virus in multiple compartments (plasma, semen, CSF).<br>