HIV InfectionsPhase 4NCT00355719
Study to Evaluate the Influence of Nevirapine to Atazanavir in Steady State Equilibrium in HIV Patients
A Phase 4 study testing Atazanavir (Reyataz), Ritonavir (Norvir) and Nevirapine (Viramune) in people with HIV Infections, run by Germans Trias i Pujol Hospital at 2 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Atazanavir (Reyataz), Ritonavir (Norvir) and Nevirapine (Viramune)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesSpain
- Study dates
- Jan 2007to Feb 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Sant Jaume de Calella
Calella, Barcelona, 08370
About this study
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 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.
Read the detailed description
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
- Conditions
- HIV Infections
- Being tested
- Atazanavir (Reyataz), Ritonavir (Norvir), Nevirapine (Viramune)
- Keywords
- Nevirapine, Atazanavir, Pharmacokinetics, Interactions
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atazanavir (Reyataz)Drug
Atazanavir (Reyataz): capsules 150 mg (2 capsules/24h)
Ritonavir (Norvir)Drug
Ritonavir (Norvir): capsules 100 mg (1 capsule/24h)
Nevirapine (Viramune)Drug
Nevirapine (Viramune): tablets 200 mg (1 tablet/12h*)
| Study group | Role | What they receive |
|---|---|---|
| Nevirapine-atazanavir | Experimental | 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. Receives: Drug: Atazanavir (Reyataz); Drug: Ritonavir (Norvir); Drug: Nevirapine (Viramune) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of the study will be the atazanavir plasma concentration
Measured: at baseline and week 4
Secondary outcomes (3)
Proportion of patients with atazanavir plasma concentrations < 0.15 mg/L
Measured: at baseline and week 4
Proportion of patients with nevirapine plasma concentrations > 6.0 mg/L
Measured: at baseline and week 4
Incidence of adverse events and anomalies in the laboratory tests (haemogram, AST / ALT / FA / GGT, bilirubin, creatinine, urea).
Measured: during the 8 weeks of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2006 (estimated)
- Study startJan 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia, Hospital San Jaime de Calella
- Responsible party
- Sponsor
- Investigators
- Bonaventura Clotet, MD,PhD, Principal investigator, LLuita contra la Sida Foundation-HIV UnitJose Molto, MD,PhD, Principal investigator, LLuita contra la Sida Foundation-HIV UnitatJosep Mª LLibre, MD,PhD, Principal investigator, Lluita contra la Sida Foundation- HIV UnitSílvia Valero, Principal investigator, Hospital Sant Jaume de Calella
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355719
- Sponsor's protocol ID
- NEVIATAZ
- Other IDs
- 2006-001140-31
- Status last verified
- Dec 2019
- First submitted
- 24 Jul 2006
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pilot Trial to Evaluate the Influence of Nevirapine in Exposure to Atazanavir in Steady State Equilibrium in HIV-infected Adult Patients.
- ClinicalTrials.gov ID
- NCT00355719
- Acronym / sponsor ID
- NEVIATAZ
- Conditions
- HIV Infections
- Keywords
- Nevirapine, Atazanavir, Pharmacokinetics, Interactions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Collaborators
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia, Hospital San Jaime de Calella
- Study start
- Jan 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 25 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nevirapine-atazanavir | Experimental | Drug: Atazanavir (Reyataz), Drug: Ritonavir (Norvir), Drug: Nevirapine (Viramune)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atazanavir (Reyataz)Atazanavir (Reyataz): capsules 150 mg (2 capsules/24h) | Drug | Nevirapine-atazanavir |
| Ritonavir (Norvir)Ritonavir (Norvir): capsules 100 mg (1 capsule/24h) | Drug | Nevirapine-atazanavir |
| Nevirapine (Viramune)Nevirapine (Viramune): tablets 200 mg (1 tablet/12h*) | Drug | Nevirapine-atazanavir |
Primary outcome
The primary endpoint of the study will be the atazanavir plasma concentration
Time frame: at baseline and week 4
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bonaventura Clotet, MD,PhD principal investigator
LLuita contra la Sida Foundation-HIV Unit
Jose Molto, MD,PhD principal investigator
LLuita contra la Sida Foundation-HIV Unitat
Josep Mª LLibre, MD,PhD principal investigator
Lluita contra la Sida Foundation- HIV Unit
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atazanavir (Reyataz), Ritonavir (Norvir) and Nevirapine (Viramune) in people with HIV Infections, run by Germans Trias i Pujol Hospital at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of the study will be the atazanavir plasma concentration (time frame: at baseline and week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2019.