Study to Evaluate the Influence of Nevirapine to Atazanavir in Steady State Equilibrium in HIV Patients
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Atazanavir (Reyataz) Drug: Ritonavir (Norvir) Drug: Nevirapine (Viramune) |
Phase 4 |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 14 |
| 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
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age >=18 years.
- Patients infected by HIV-1 (at least one documented positive Western-Blot).
- Stable antiretroviral treatment with atazanavir boosted with ritonavir (300/100 mg QD) for at least 14 days.
- Absence of acute infections and/or tumours in the three months prior to inclusion.
- Subject able to follow the treatment period.
- Transaminase values (AST/ALT) below 5 times the upper limit of the interval of normality.
- In women, negative pregnancy test or not of fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or undertaking to use a barrier contraceptive method during the study.
- Signature of the informed consent.
- Undetectable viral load.
Exclusion Criteria:
- Failure to comply with any of the inclusion criteria.
- Record of allergic hypersensitivity or intolerance to the investigational medication.
- Any clinical or historic observation that might interfere in the pharmacokinetics of the medication, such as gastrointestinal diseases or surgery (except herniotomy or appendectomy), alterations in the composition of plasma proteins, any indication of hepatic or renal dysfunction.
- Patients that have been given tenofovir, omeprazole or other proton pump inhibitors or any other medication with relevant interactions with atazanavir within the two weeks prior to the screening visit.
- Active consumption of alcohol (> 50 g/day) or illegal drugs (except cannabis).
- Suspicion of unsuitable antiretroviral treatment compliance.
- Pregnancy or breastfeeding.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00355719
| Spain | |
| 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 |
More Information
No publications provided
| Responsible Party: | LLuita Sida Foundation |
| ClinicalTrials.gov Identifier: | NCT00355719 History of Changes |
| Other Study ID Numbers: | NEVIATAZ, 2006-001140-31 |
| Study First Received: | July 24, 2006 |
| Last Updated: | June 16, 2009 |
| Health Authority: | Spain: Ministry of Health |
Keywords provided by Germans Trias i Pujol Hospital:
|
Nevirapine Atazanavir Pharmacokinetics Interactions |
Additional relevant MeSH terms:
|
Atazanavir Nevirapine Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents Enzyme Inhibitors |
HIV Protease Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Protease Inhibitors Reverse Transcriptase Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015