Study to Evaluate the Activity and Tolerability of Lopinavir/Ritonavir and Lamivudine Bitherapy in HIV Patients With Viral Suppression

Study Overview
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Brief Summary
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This is a prospective, open controlled trial in which HIV-1 with viral suppression patients will be randomized to continue with their current treatment (lopinavir/ritonavir plus emtricitabine or lamivudine plus any nucleoside analogue reverse transcriptase inhibitor) or to simplify to lopinavir/ritonavir plus lamivudine. Randomization will be stratified according to the values of nadir CD4 and time of viral suppression.

Official Title
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Study to Evaluate the Activity and Tolerability of Lopinavir/Ritonavir and Lamivudine Bitherapy Instead of a Triple Therapy That Includes Lopinavir/Ritonavir and Lamivudine or Emtricitabine in HIV Patients With Viral Suppression: Controlled Clinical Trial, Open Label, Randomized, of 48 Weeks of Follow-up

Conditions
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HIV Infection

Intervention / Treatment
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* Drug: antiretroviral treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of either sex (female or male) and 18 years or older. Patients seropositive for HIV-1 using standard diagnostic criteria. There is confirmation of viral load to be lower than 50 cop/ml during the 6 previous months to inclusion. The requirement is to have at least two viral loads lower than 50 cop/mL separated by 6 months and no one >50cop/mL during the 6 months before inclusion. Patients on continuous HAART consisting of LPV/r, emtricitabine (FTC) or 3TC (lamivudine) and an NRTI for at least 2 months before being randomized in this study. Patients who are clinically stable, in the opinion of the investigator, at entry into the study (clinical status and chronic medication must not have not been modified at least 14 days prior to randomization). Patients receiving therapy for an active opportunistic infection are eligible for enrollment if the above criteria are met. Standard prophylaxis of opportunistic infections is permitted. Exclusion Criteria: Pregnancy, nursing, or planned pregnancy during the study period. Previous failure with regimens including a protease inhibitor (PI) or 3TC/FTC. Known resistance mutations to PIs or 3TC/FTC. Patients with an active opportunistic infection or malignancy. Patients with a stable chronic opportunistic infection may be included in the study. Any disease or history of disease which, in the opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment. Patients diagnosed with visceral Kaposi's sarcoma (KS), patients with lymphoedema secondary to cutaneous KS or cutaneous or palatine KS who have been treated with systemic immunosuppressive therapy must also be excluded. Patients with chronic hepatitis B on treatment with tenofovir + 3TC/FTC

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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: simplification<br>Lopinavir/ritonavir (400/100 BID) plus lamivudine (300 QD) | Drug: antiretroviral treatment<br>* antiretroviral treatment<br>|
| Active Comparator: Continue with current treatment<br> | Drug: antiretroviral treatment<br>* antiretroviral treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with no treatment failure | viral failure, defined as two viral loads above 50 copies/ml at least two weeks apart death developing new CDC-C events withdrawing consent being lost to follow-up switching assigned treatment for any cause | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with no viral failure | defined as two viral loads above 50 copies/ml. Patients lost to follow-up or changing treatment will not be taken into account for this analysis | 48 weeks | 
| Proportion of patients with no therapeutical failure | defined as in the primary outcome but with two viral loads above 400 copies/ml, not 50 as in the primary outcome. | 48 weeks | 
| Proportion of patients with no viral failure | defined as two viral loads above 400 copies/ml | 48 weeks | 
| Time to viral failure | Two different analysis will be carried out: with 50 copies/ml threshold and with 400 copies/ml threshold | 48 weeks | 
| Proportion of patients with blips | Defined as one viral load above 50 and below 400 copies/ml with next viral load below 50 copies/ml | 48 weeks | 
| Change from baseline CD4 |  | 48 weeks | 
| Lipidic profile change from baseline |  | 48 weeks | 
| Creatinine clearance change from baseline |  | 48 weeks | 
| Proportion of patients with proximal tubular renal disfunction |  | 48 weeks | 
| Lipodystrophy changes from baseline | evaluated using two questionnaires: lipoatrophy and fat accumulation | 48 weeks | 
| Adherence to treatment |  | 48 weeks | 
| Mortality and progression to AIDS |  | 48 weeks | 
| Adverse events per treatment branch |  | 48 weeks | 
| Proportion of patients switching study treatment due to an adverse event |  | 48 weeks | 
| Proportion of serious adverse events related to treatment |  | 48 weeks |