HIV Infections Clinical Trial
Official title:
A 48-Week, Randomised, Study to Describe the Pharmacokinetic Profile and Durability of Atazanavir-Saquinavir-Ritonavir Once Daily and Describe the Pharmacokinetic Profile of Saquinavir-Ritonavir Using Saquinavir 500mg Formulation.
Saquinavir and Atazanavir are drugs used in combination therapy to treat HIV disease. Saquinavir is currently available in a 200 milligram capsule. Most individuals currently on saquinavir require to take 5 tablets twice a day. In an attempt to reduce this number of pills, a new capsule has been developed containing 500 milligrams of saquinavir. This study will assess: i) blood drug levels in individuals taking both saquinavir formulations, ii) blood drug levels in individuals taking both saquinavir formulations when given with atazanavir, iii) 48 weeks of follow up for individuals receiving the new saquinavir formulation with atazanavir as HIV therapy.
BACKGROUND The development of anti-HIV therapy for the treatment of HIV disease has improved
the quality of life and survival of many people with HIV. However the treatments do not
always work over long periods, as medications are often difficult to take due to side
effects and a large numbers of pills to be taken. This has lead researchers to look for new
ways to treat HIV with medications that require fewer numbers of pills and have fewer side
effects.
Atazanavir and saquinavir are two drugs used to treat HIV and come from the same class of
drugs known as the protease inhibitors. Atazanavir has the advantage of being taken only
once a day. Saquinavir is available in a new formulation (type of pill), which will require
fewer numbers of pills to be taken daily.
AIM The purpose of this study is to investigate the use of these two drugs used together
with ritonavir as a once daily HIV treatment, which will consist of 6 tablets.
Furthermore this study will look at blood drug levels in individuals on atazanavir,
saquinavir and ritonavir with and without the new saquinavir formulation to ensure blood
levels of these drugs are adequate.
For individuals currently on the old saquinavir formulation, this study will also look at
blood drug levels before and after changing to the new formulation.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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