HAART followed by maintenance with monotherapy - Kaletra (MAIMOKA)

Completed

• Conditions: Human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS); Infections and Infestations; Human immunodeficiency virus (HIV)

• Registration Number: ISRCTN45284754
• Lead Sponsor: Vrije University Medical Centre (VUMC) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-27
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 240

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified