Clinical trials: new questions and recent answers | Fight AIDS Foundation

Clinical trials: new questions and recent answers

05/08/2013

CLINICAL STUDIES THAT WILL BEGIN SHORTLY

PI & ENDOTHELIUM:

 

It has been demonstrated that antiretroviral treatment (drug family of protease inhibitors mostly) is associated with a negative impact on the lipid profile (blood fats). For example, medication may cause an increase in cholesterol or triglycerides.

 

The goal of this study is to see if, in addition, the treatment can have a harmful effect on the arteries's wall, thus increasing cardiovascular risk.

 

CARDIO-VIH-MBSR:

 

Its aim is to assess the effectiveness of a two months psychoeducational program, based on Mindfulness techniques, to improve the quality of life and reduce cardiovascular risk in HIV-infected people.

 

Minfulness can be understood as attention and awareness. Practicing it, you learn how to focus on the present moment, avoiding feelings, concerns or thoughts that keep us away from it. The minfulness based techniques have been proven useful in minimizing the anxiety, reducing stress or chronic pain, regulating blood pressure, learning to breathe better, reducing psychological distress, etc.

 

OSTEODOLU:

One of the negative side effects that antiretroviral drugs may have is bone toxicity. The Osteodolu is a multicenter clinical trial (involving the Hospital de la Santa Creu i Sant Pau, Hospital Clinico San Carlos and Hospital Germans Trias i Pujol) to assess what changes would occur in bone mineral density by changing a protease inhibitor drug by dolutegravir, a drug from a new antiretrovirals family, integrassa inhibitors. To participate,  undetectable viral load and low bone mineral density are needed.

 

FINISHED AND PUBLISHED STUDIES

 

MARAVI-SWITCH:

 

The aim of the study was to observe the effect of changing an antiretroviral drug to maraviroc, a drug that, in some cases, may involve a simplification of the HIV treatment. The study included 30 patients; 15 of them changed medication and 15 did not. The assignment to one group or another was made ​​at random.

 

Switching to Maraviroc was generally well tolerated (only one patient discontinued the new treatment due to intolerance) and CD4 count - the main cells in the immune system - remained stable in both groups. However, maraviroc group experienced a small decrease in cholesterol and a significant decrease in triglyceride levels, what makes advisable to switch to maraviroc whenever it is possible.

 

The results of this study have been published in the Journal of Antimicrobial Chemotherapy.

 

ECHI-ETRA:

 

The aim of this study was to evaluate the potential drug interaction between Echinacea purpurea, a medicinal plant, and etravirine, an antiretroviral drug. We included 15 patients who were treated with etravirine. Several extractions were performed on the same day to determine drug levels in blood and then capsules of Echinacea purpurea were added to the treatment for 14 days. Then, extractions were performed again and results were compared.

 

The study concluded that the combination of these therapies is safe and well tolerated, and therefore it is not necessary to adjust the dose of etravirine in this case. The results of the study have been published in the journal Antimicrobial Agents and Chemotherapy.

 

We do appreciate very much the participation of hundreds of patients in these and other studies. Without their collaboration, they could not have been perdormed. Thank you!

 

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