HIV Infections Clinical Trial
Official title:
A Randomized Comparative Clinical Trial of ZDV + 3TC + ABC (Trizivir) vs Monotherapy With Lopinavir/R (Kaletra) in Patients With Viral Suppression on Previous Treatment With ZDV + 3TC + ABC (Trizivir) for Preventing Lipoatrophy
The aim of this study is to measure the prevention of lipoatrophy in patients treated with Lopinavir/R in monotherapy versus ZDV + 3TC + ABC
In recent years mayor progress has been made in therapeutic approaches with the introduction
of HAART, which has meant a huge fall in morbidity-mortality in Western countries.
However, despite having a variety of potent HAART combinations, some patients do not obtain
adequate suppression. The causes of virological failure are complex, and one of the most
significant factors is the incomplete compliance with the prescribed dosage of highly-active
antiretroviral therapy (HAART). The development of fixed dose combination products is most
commonly used to help simplify the dosages and improve treatment compliance.
One of the main problems associated with the treatment of HIV infection is the change in
body structure, generally grouped under the term of lipodystrophy. These usually include fat
accumulation in the stomach, or abdominal girth, and, even worse, atrophy in the face, arms,
and legs. It is usually associated with metabolic disorders, with increased levels of
triglycerides, cholesterol and/or insulin resistance.
The incidence of lipodystrophy increases progressively over time in patients starting
treatment with antiretroviral agents. It is estimated that, after 2 years of treatment,
20%-30% of patients experience moderate or severe lipodystrophy.
Trizivir® is a combination of three antiretroviral agents: Abacavir, Lamivudine and
Zidovudine in a tablet. All of them belong to the group of nucleoside/nucleotide analogue
reverse transcriptase inhibitors (NRTIs.
The main advantage of Trizivir is the possibility of simplifying antiretroviral treatment.
Multiple studies have been performed showing that simplification of HAART with Trizivir
enhances compliance and improves quality of life in patients maintaining the efficacy of
previous antiretroviral treatments.
Kaletra® (lopinavir+ritonavir) is a combination of two protease inhibitors: lopinavir plus a
low dose of ritonavir, enhancing the action of the former.
Previous studies have shown that most patients treated with Kaletra monotherapy have an
undetectable viral load after 48 weeks. Monotherapy failures were not associated with the
development of primary resistance mutations.
To date the development of lipoatrophy appears to occur more frequently in patients with a
NRTI- containing regimen. The combination of abacavir, zidovudine and lamivudine has been
investigated in patients naive to antiretroviral treatments and in patients already treated
with NRTIs.
In this setting, we designed this clinical trial to establish the potential benefit of
Kaletra in monotherapy for the prevention of lipoatrophy. For this purpose, we will compare
keeping on treatment with TZV in patients with viral suppression vs switching to Kaletra in
monotherapy in order to prevent fat changes.
Since the purpose of the study is to establish the ability of Kaletra to prevent the
development of and exclude patients with acute intolerance to Kaletra, the patients assigned
to the experimental group will be treated for 4 weeks with Trizivir and Kaletra before
switching to Kaletra monotherapy.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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