Study to Evaluate the Influence of Nevirapine to Atazanavir in Steady State Equilibrium in HIV Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00355719|
Recruitment Status : Completed
First Posted : July 25, 2006
Last Update Posted : December 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Atazanavir (Reyataz) Drug: Ritonavir (Norvir) Drug: Nevirapine (Viramune)||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Pilot Trial to Evaluate the Influence of Nevirapine in Exposure to Atazanavir in Steady State Equilibrium in HIV-infected Adult Patients.|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
Atazanavir/ritonavir 300/100 mg once daily for ≥2 weeks. Nevirapine was added at a dose of 200 mg once daily from days 0 to 14, and 200 mg twice daily from days 14 to 28.
Drug: Atazanavir (Reyataz)
Atazanavir (Reyataz): capsules 150 mg (2 capsules/24h)
Drug: Ritonavir (Norvir)
Ritonavir (Norvir): capsules 100 mg (1 capsule/24h)
Drug: Nevirapine (Viramune)
Nevirapine (Viramune): tablets 200 mg (1 tablet/12h*)
- The primary endpoint of the study will be the atazanavir plasma concentration [ Time Frame: at baseline and week 4 ]
- Proportion of patients with atazanavir plasma concentrations < 0.15 mg/L [ Time Frame: at baseline and week 4 ]
- Proportion of patients with nevirapine plasma concentrations > 6.0 mg/L [ Time Frame: at baseline and week 4 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00355719
|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|