HIV InfectionsPhase 4NCT00415090
Study to Evaluate the Replacement of Reverse Transcriptase Nucleoside/Nucleotide Inhibitors by Nevirapine in Patients on Triple Treatment With Analogues Only
A Phase 4 study testing Nevirapine in people with HIV Infections, run by Hospital de Calella at 17 sites in Spain.
Trial summary
The purpose of this study is to evaluate the proportion of patients with viral load of HIV-1 < 50 copies after 48 weeks of follow-up after randomization to change or not to nevirapine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Nevirapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 17 sitesSpain
- Study dates
- Aug 2004to Jul 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients on triple treatment with 3 nucleoside analogues or transcriptase nucleotide inhibitors in virological suppression.
- Age >= 18 years.
- Confirmed diagnosis of HIV-1 infection.
- Viral load < 50 copies/ml over the previous six months, including at least two consecutive determinations.
- Value of ALT transaminase £ 2.5 times the normal value of the laboratory of each centre.
- Acceptance and signature of the informed consent form.
Who cannot join
- Pregnant women or those who intend to become pregnant in the study period.
- Having had an active infection in the previous month.
- Previous exposure to any reverse transcriptase non-nucleoside inhibitor (nevirapine, efavirenz or delavirdine).
- Simultaneous treatment with methadone.
- Patients with serious hepatic dysfunction
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Spain17 sites
Hospital.Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Centre Penitenciari Brians
Barcelona, Barcelona, 08009
Hopsital de Sant Pau
Barcelona, Barcelona, 08025
Hospital Vall d'Hebron
Barcelona, Barcelona, 08035
Hospital Clínic i Provincial de Barcelona
Barcelona, Barcelona, 08036
Hospital Sant Jaume de Calella
Barcelona, Barcelona, 08370
Centre Penitenciari Homes
Barcelona, Barcelona
Hospital General de Granollers
Granollers, Barcelona, 08400
Centre Penitenciari Quatre Camins
Granollers, Barcelona, 08430
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Clínico San Carlos de Madrid
Madrid, Madrid, 28040
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, 43201
Hospital La Candelaria
Santa Cruz de Tenerife, Canary Islands, 38010
Mutua de Terrassa
Terrassa, Barcelona, 08221
Hospital de Tortosa
Tortosa, 43500
Hospital La Fe de Valencia
Valencia, Valencia, 46009
Hospital Miguel Servet
Zaragoza, Zaragoza, 50009
About this study
Official title: Substitution by Nevirapine in HIV-1 Infected Patients on Triple Treatment of Reverse Transcriptase Nucleoside/Nucleotide Inhibitors
The purpose of this study is to evaluate the proportion of patients with viral load of HIV-1 < 50 copies after 48 weeks of follow-up after randomization to change or not to nevirapine.
Read the detailed description
RTNI (reverse transcriptase nucleoside inhibitors) are a regular part of most antiretroviral combinations. The presence of a smaller or greater degree of cross resistance among all RTNI is increasingly better described and acknowledged, whereby the number of salvage regimens that may be built following the appearance of this resistance to these drugs is by no means unlimited.
This proactive treatment change in patients on RTNI-based regimens while the viral load is still suppressed would avoid the selective replication period under antiviral pressure following the failure of the regimen in which resistance-associated mutations accumulate. This therapeutic approach has demonstrated its effectiveness in clinical practice, albeit not in this scenario.
If we wait until the viral load is detectable there is sufficient evidence that resistance to RTNI will appear and that this resistance will compromise future salvage options.
To intensify with this proactive approach these combinations based on N/NNRTI (nucleotide analog), the NNRTI are an optimal alternative.There is vast experience with NVP in simplification/maintenance trials. In direct comparative simplification studies in patients with virological response, the response rates with NVP or EFV have shown no differences. With a relative risk (RR) of virological failure of 0.54 with regard to the continuation of PI (protease inhibitors), NVP is one of the best simplification treatment options in HIV-1-infected patients.
- Conditions
- HIV Infections
- Being tested
- Nevirapine
- Keywords
- Nevirapine, Antiretroviral treatment, Triple nucleoside therapy, HIV, Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NevirapineDrug
Also called Switch one of ARV drugs to Nevirapine
Switch one of ARV drugs to Nevirapine
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Follow with same ARV treatment |
| 2 | Experimental | Switch one of ARV drugs to Nevirapine Receives: Drug: Nevirapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with plasma viral load below 50 copies/mL .
Measured: after 48 weeks of follow-up
Secondary outcomes (6)
Time to the appearance of viral load >50 copies/mL in both branches (two consecutive determinations with 4-week separation between both).
Measured: During the 48 weeks of follow-up.
Evolution of the CD4 lymphocyte count at 48 weeks.
Measured: during 48 weeks of follow-up
Pattern of mutations associated with resistance in patients presenting virological failure.
Measured: When there is a virological failure
Incidence of adverse clinical effects and laboratory alterations, giving rise or not to the withdrawal of the investigational treatment.
Measured: during the 48 weeks of follow-up
Incidence of AIDS-defining events (CDC C events, 1993).
Measured: during the 48 weeks of follow-up
Mortality by any cause.
Measured: during the 48 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 posted22 Dec 2006 (estimated)
- Study startAug 2004
- Primary completionJul 2006
- Study completionJul 2006
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Calella
- Sponsor type
- University, hospital or other
- Investigators
- Josep Mª Llibre, MD,PhD, Principal investigator, Hospital Sant Jaume de Calella
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415090
- Sponsor's protocol ID
- TRIMUNE
- Status last verified
- Oct 2008
- First submitted
- 19 Dec 2006
- Last updated
- 31 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substitution by Nevirapine in HIV-1 Infected Patients on Triple Treatment of Reverse Transcriptase Nucleoside/Nucleotide Inhibitors
- ClinicalTrials.gov ID
- NCT00415090
- Acronym / sponsor ID
- TRIMUNE
- Conditions
- HIV Infections
- Keywords
- Nevirapine, Antiretroviral treatment, Triple nucleoside therapy, HIV, Treatment Experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hospital de CalellaUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 22 Dec 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 proportion of patients with viral load of HIV-1 < 50 copies after 48 weeks of follow-up after randomization to change or not to nevirapine.
Detailed description
RTNI (reverse transcriptase nucleoside inhibitors) are a regular part of most antiretroviral combinations. The presence of a smaller or greater degree of cross resistance among all RTNI is increasingly better described and acknowledged, whereby the number of salvage regimens that may be built following the appearance of this resistance to these drugs is by no means unlimited.
This proactive treatment change in patients on RTNI-based regimens while the viral load is still suppressed would avoid the selective replication period under antiviral pressure following the failure of the regimen in which resistance-associated mutations accumulate. This therapeutic approach has demonstrated its effectiveness in clinical practice, albeit not in this scenario.
If we wait until the viral load is detectable there is sufficient evidence that resistance to RTNI will appear and that this resistance will compromise future salvage options.
To intensify with this proactive approach these combinations based on N/NNRTI (nucleotide analog), the NNRTI are an optimal alternative.There is vast experience with NVP in simplification/maintenance trials. In direct comparative simplification studies in patients with virological response, the response rates with NVP or EFV have shown no differences. With a relative risk (RR) of virological failure of 0.54 with regard to the continuation of PI (protease inhibitors), NVP is one of the best simplification treatment options in HIV-1-infected patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Follow with same ARV treatment |
| 2 | Experimental | Drug: NevirapineSwitch one of ARV drugs to Nevirapine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients on triple treatment with 3 nucleoside analogues or transcriptase nucleotide inhibitors in virological suppression.
- Age >= 18 years.
- Confirmed diagnosis of HIV-1 infection.
- Viral load < 50 copies/ml over the previous six months, including at least two consecutive determinations.
- Value of ALT transaminase £ 2.5 times the normal value of the laboratory of each centre.
Key exclusion criteria (5 listed)
- Pregnant women or those who intend to become pregnant in the study period.
- Having had an active infection in the previous month.
- Previous exposure to any reverse transcriptase non-nucleoside inhibitor (nevirapine, efavirenz or delavirdine).
- Simultaneous treatment with methadone.
- Patients with serious hepatic dysfunction
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 |
|---|---|---|
| NevirapineAlso: Switch one of ARV drugs to NevirapineSwitch one of ARV drugs to Nevirapine | Drug | 2 |
Primary outcome
Proportion of patients with plasma viral load below 50 copies/mL .
Time frame: after 48 weeks of follow-up
6 secondary outcomes
Time to the appearance of viral load >50 copies/mL in both branches (two consecutive determinations with 4-week separation between both).
Time frame: During the 48 weeks of follow-up.
Evolution of the CD4 lymphocyte count at 48 weeks.
Time frame: during 48 weeks of follow-up
Pattern of mutations associated with resistance in patients presenting virological failure.
Time frame: When there is a virological failure
Incidence of adverse clinical effects and laboratory alterations, giving rise or not to the withdrawal of the investigational treatment.
Time frame: during the 48 weeks of follow-up
Incidence of AIDS-defining events (CDC C events, 1993).
Time frame: during the 48 weeks of follow-up
Mortality by any cause.
Time frame: during the 48 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 31 Oct 2008.
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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.
Josep Mª Llibre, MD,PhD principal investigator
Hospital Sant Jaume de Calella
17 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 Nevirapine in people with HIV Infections, run by Hospital de Calella at 17 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 6 inclusion and 5 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 31 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
Proportion of patients with plasma viral load below 50 copies/mL . (time frame: after 48 weeks of follow-up). 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 31 Oct 2008.