HIV/AIDS
Conditions
Interventions
Experimental 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)
Sponsors
VU Medical Center
and
University Medical Center Utrecht
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Genotypic resistance of the virus in multiple compartments (plasma, semen, CSF). | — |
Contacts
Public ContactW.F.W. Bierman
VU Medical Center, Department of Internal Medicine, P.O. Box 7057
Outcome results
None listed