HIV Infections Clinical Trial
Official title:
Study on the Feasibility of Antiretroviral Therapy With a Single Agent - Lopinavir/r - in Patients Treated With HAART and With Viral Load Below 80 Copies/Ml
1. Objectives Primary
- To investigate the possibility of maintaining virological suppression of HIV in
infected patients, switching them to LPV/r as the only antiretroviral agent
- To assess the immunological response in patients who switched to LPV/r as single
agent, based on the observation of changes in the serum levels of CD4+ cells.
Secondary
- To investigate the rate of clinical and laboratorial adverse events in the two
treatment groups.
- To investigate the rate of emergence of antiretroviral resistance mutations in the
two treatment groups, in case of virological failure of the current regimen.
- To describe the adherence to the prescribed regimen in the two treatment groups
- To describe changes in body fat distribution (abdominal, arms and thigh
circumference) and in the lipid profile, in patients from the two treatment groups
- To describe the rate of clinical failure of the antiretroviral therapy in the two
treatment groups.
2. Patient population:
The 60 patients were selected by the investigators according to the study’s inclusion
and exclusion criteria, and were divided into 2 groups with 30 patients each.
3. Study design:
The study is multicentric, open-label, randomized. Virological, immunological and
clinical failures will be analyzed in both groups. In addition, data on clinical or
laboratorial toxicity and compliance are being recorded.
4. Regime:
- Group 1 maintenance of the currently used antiretroviral therapy
- Group 2 switch to LPV/r antiretroviral monotherapy in the dose of 400/100 mg 12/12
hs with food. Patients in group 2 who were being treated previously with
non-nucleoside reverse transcriptase inhibitors (Efavirenz or Nevirapine) were
instructed to take 4 capsules of Lopinavir/r each 12 hs, during the first 14 days
of therapy (up to Week 2 visit).
5. Duration:
96 weeks of treatment
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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