Efficacy and Safety of Kaletra Monotheraphy Compared to Kaletra Based Triple Therapy to Treat HIV in Antiretroviral Naїve Patients

Study Overview
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Brief Summary
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The purpose of this pilot study is to obtain a preliminary assessment of the antiviral activity and tolerability of Kaletra single agent therapy as initial treatment for HIV infection, relative to a Kaletra three drug standard of care reference arm

Official Title
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A Pilot, Open-Label, Randomized, Comparative Study of the Antiviral Efficacy of Lopinavir/Ritonavir Single-Drug Regimen Versus Lopinavir/Ritonavir in Combination With Lamivudine/Zidovudine in Antiretroviral Naïve Patients

Conditions
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HIV Infection

Intervention / Treatment
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* Drug: lopinavir/ritonavir
* Drug: lamivudine/zidovudine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Antiretroviral naïve HIV RNA <100,000 copies/mL CD4 cell count >100 cells/mL at screening with Karnofsky Score > 70 If female, non-pregnant and not breastfeeding No AIDS opportunistic infection within 30 days of screening Exclusion Criteria: Subject with an HIV primo-infection status Recent history of drug and/or alcohol abuse History of psychiatric illness If presence of the following mutations : in the protease : one among 32,47,48,50,82,84,90 OR more than 3 mutations from the other points of the LPV mutation score:10,20,24,46,53,54,63,71 in the reverse transcriptase : 215 or 184. If abnormal laboratory results such as : Hb<8 g/dl Absolute neutrophil count<750 cells/µl Platelet count<50 000/ml

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Kaletra Monotherapy: lopinavir/ritonavir | Drug: lopinavir/ritonavir<br>* 400 mg lopinavir/ 100 mg ritonavir, BID<br>* Other names: Kaletra;|
| Active Comparator: 2<br>Kaletra based triple therapy: lopinavir/ritonavir + lamivudine/zidovudine | Drug: lopinavir/ritonavir<br>* 400 mg lopinavir/ 100 mg ritonavir, BID<br>* Other names: Kaletra;Drug: lamivudine/zidovudine<br>* 300mg lamivudine/150mg zidovudine, BID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antiviral efficacy by HIV RNA |  | 48 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arm comparisons: CD4 evolution, occurrence of HIV protease and RT mutation, occurrence of AIDS clinical events, safety of NRTI-sparing vs. a PI with 2 NRTIs regimen: clinical and biological tolerance, patient's adherence and quality of life. |  | 48 weeks | 
| To assess in the LPV/r single-drug regimen arm: virological control, CD4 evolution, safety |  | 96 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV Infection, Kaletra, Lopinavir, Ritonavir, Treatment Naive