NL-OMON20599
Suspended
Not Applicable
A randomised controlled trial in HIV positive patients comparing the efficacy of lopinavir/ritonavir monotherapy versus conventional triple therapy.
VU Medical CenterandUniversity Medical Center Utrecht0 sites240 target enrollmentTBD
ConditionsHIV/AIDS
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV/AIDS
- Sponsor
- VU Medical CenterandUniversity Medical Center Utrecht
- Enrollment
- 240
- Status
- Suspended
- Last Updated
- 2 years ago
Overview
Brief Summary
/A
Investigators
Eligibility 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
- •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;
Outcomes
Primary Outcomes
Not specified
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