Study to Evaluate the Influence of Nevirapine to Atazanavir in Steady State Equilibrium in HIV Patients
The purpose of this study is to evaluate the influence of nevirapine in exposure to atazanavir boosted with ritonavir, in steady state equilibrium, in HIV-infected adult patients.
Drug: Atazanavir (Reyataz)
Drug: Ritonavir (Norvir)
Drug: Nevirapine (Viramune)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Pilot Trial to Evaluate the Influence of Nevirapine in Exposure to Atazanavir in Steady State Equilibrium in HIV-Infected Adult Patients.|
- The primary endpoint of the study will be the atazanavir plasma concentration [ Time Frame: at baseline and week 4 ] [ Designated as safety issue: No ]
- Proportion of patients with atazanavir plasma concentrations < 0.15 mg/L [ Time Frame: at baseline and week 4 ] [ Designated as safety issue: No ]
- Proportion of patients with nevirapine plasma concentrations > 6.0 mg/L [ Time Frame: at baseline and week 4 ] [ Designated as safety issue: No ]
- Incidence of adverse events and anomalies in the laboratory tests (haemogram, AST / ALT / FA / GGT, bilirubin, creatinine, urea). [ Time Frame: during the 8 weeks of follow-up ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2007|
|Study Completion Date:||February 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Drug: Atazanavir (Reyataz)
In recent years, new treatment strategies have appeared aimed at reducing the risk of treatment-derived toxicity without compromising efficacy.
Of the recent antiretroviral drugs, atazanavir is a protease inhibitor (PI) whose pharmacokinetic profile allows it to be given in a single daily take with a scant impact on lipid metabolism. This second characteristic makes atazanavir a good alternative for patients with a high vascular risk. However, one of its drawbacks is that it may present clinically relevant interactions with other drugs.
Another antiretroviral agent with a scant impact on lipid metabolism is nevirapine. Different studies have described an improvement in lipid profile, as well as a less atherogenic tendency in patients treated with nevirapine. Moreover, the combination of nevirapine with PI drugs in the context of nucleoside-sparing strategies may permit a suitable control of viral replication, and an improvement in the mitochondrial toxicity derived from treatment with NTRI, which may possibly result in a minor incidence or in a clinical improvement of lipodystrophy.
The combination of atazanavir with nevirapine may be of major interest in HIV-infected patients that have had a cardiovascular event (secondary prevention) or are at a high risk of having one (primary prevention). Similarly, this combination of drugs may be promising as a nucleoside-sparing strategy. However, according to preliminary data, the joint administration of nevirapine with atazanavir may lead to a reduction in the atazanavir plasma concentration. Thus, before evaluating the clinical utility of this combination of drugs, pharmacokinetic studies evaluating the existence of significant pharmacokinetic interactions between both are necessary
|Hospital Universitari Germans Trias i Pujol|
|Badalona, Barcelona, Spain, 08916|
|Hospital Sant Jaume de Calella|
|Calella, Barcelona, Spain, 08370|
|Principal Investigator:||Bonaventura Clotet, MD,PhD||LLuita contra la Sida Foundation-HIV Unit|
|Principal Investigator:||Jose Molto, MD,PhD||LLuita contra la Sida Foundation-HIV Unitat|
|Principal Investigator:||Josep Mª LLibre, MD,PhD||Lluita contra la Sida Foundation- HIV Unit|
|Principal Investigator:||Sílvia Valero||Hospital Sant Jaume de Calella|