HIV-1-infectionNCT01437241
Etravirine Plus 2 Analogs in HIV-infected Patients
An observational study of HIV-1-infection, run by Hospitales Universitarios Virgen del Rocío at 11 sites in Spain.
Trial summary
The purpose of this study is to evaluate the virological and clinical efficacy of etravirine plus 2 active nucleos(t)ide reverse-transcriptase inhibitors (NRTIs) in HIV-infected patients. Additionally, the safety of these regimens, specially lipid profiles, will be assessed. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HIV-1-infection
- How many people
- 175 participants
- Where
- 11 sitesSpain
- Study dates
- Jan 2009to Sep 2011
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV-infected patients who strated an antirretroviral regimen based on etravirine plus 2 NRTIs between January 2009 and June 2010
Who may be able to join
- Older than 18 years, starting an antiretroviral regimen based on etravirine plus 2 NRTIs between January 2009 and June 2010, evidence of activity of all drugs on the basis of treatment history and genotypic resistance testing, informed consent, and at least one follow-up visit.
Who cannot join
- Genotypic resistance tests with evidence of resistance to any drug used, and concomitant use of drugs with potentially adverse interactions with etravirine pharmacokinetics, such as rifampin.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Spain11 sites
Hospital Universitario Reina Sofía
Córdoba, Cordoba, 14004
Hospital Universitario San Cecilio
Granada, Granada, 04009
Hospital Universitario Virgen de las Nieves
Granada, Granada, 18014
Hospital Ciudad de Jaén
Jaén, Jaen, 23001
Hospital La Linea de la Concepción
La Linea de La Concepción, Cadiz, 11300
Hospital Universitario Carlos Haya
Málaga, Malaga, 29010
Hospital Universitario Virgen de la Victoria
Málaga, Malaga, 29010
Hospital Costa del Sol
Marbella, Malaga, 29600
Hospital Universitario Puerto Real
Puerto Real, Cadiz, 11510
Hospital Universitario Virgen del Rocio
Seville, Sevilla, 41013
Hospital Universitario Virgen de Valme
Seville, Sevilla, 41014
About this study
Official title: Virological Efficacy and Safety of Etravirine Plus 2 Active Nucleos(t)Ide Reverse-transcriptase Inhibitors (NRTIs) in HIV-1-infected Patients
The purpose of this study is to evaluate the virological and clinical efficacy of etravirine plus 2 active nucleos(t)ide reverse-transcriptase inhibitors (NRTIs) in HIV-infected patients. Additionally, the safety of these regimens, specially lipid profiles, will be assessed.
Read the detailed description
Methods: prospective, single arm multicenter clinical trial without entry restrictions on plasma HIV-RNA (VL) or CD4 with a planned duration of 52 weeks.
The primary clinical endpoint is the percentage of subjects with therapeutic success on etravirine 400 mg/day (200 mg bid or 400 mg qd) plus 2 active NRTIs after 12 months. Efficacy data will be analyzed by on-treatment and by intention-to-treat analyses (noncomplete/missing equals failure), considering treatment failure as either treatment interruption whatever the reason (adverse events, death, or loss to follow-up) or virological failure, defined as inability to suppress the VL to less than 50 copies/ml after 24 weeks on treatment or a confirmed VL of more than 200 copies/ml in patients who had previously achieved a viral suppression or had an undetectable viral load at inclusion.
Patients missing two consecutive scheduled visits were considered lost to follow-up. The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results.
NRTIs prescribed as part of HAART were selected by the responsible physicians on the basis of previous antiretroviral treatments and/or genotypic resistance testing.
- Conditions
- HIV-1-infection
- Keywords
- HIV-infection, Etravirine, Treatment, Non-nucleoside reverse-transcriptase inhibitor
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| etravirine | Antiretroviral regimens based on etravirine plus 2 active nucleos(t)ide reverse-transcriptase inhibitors (NRTIs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virological efficacy
Percentage of subjects with therapeutic success at month 12. Efficacy data will be analyzed by on-treatment and by intention-to-treat considering treatment failure as either treatment interruption whatever the reason (adverse events, death, or loss to follow-up) or virological failure, defined as inability to suppress the VL to <50 copies/ml after 24 weeks or a confirmed VL of >200 copies/ml in patients who had previously achieved a viral suppression or had an undetectable viral load at inclusion. Patients missing two consecutive scheduled visits were considered lost to follow-up.
Measured: 52 weeks
Secondary outcomes (1)
Safety
The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2011 (estimated)
- Study startJan 2009
- Primary completionJul 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospitales Universitarios Virgen del Rocío
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis F. Lopez-Cortes, Hospitales Universitarios Virgen del Rocío
- Investigators
- Luis F Lopez-Cortes, MD, PhD., Principal investigator, Hospitales Universitarios Virgen del RocíoFrancisco Tellez-Perez, MD, Principal investigator, Hospital de la Linea de la ConcepcionAntonio Vergara-Campos, MD, PhD., Principal investigator, Hospital Universitario de Puerto RealMilagros Garcia-Lazaro, MD, Principal investigator, Hospital Universitario Reina Sofia de CordobaJose Hernandez-Quero, MD, PhD., Principal investigator, Hospital Universitario San CecilioJuan Pascuau-Liaño, MD, PhD., Principal investigator, University Hospital Virgen de las NievesMiguel A Lopez-Ruz, MD, PhD, Principal investigator, University Hospital Virgen de las NievesMohamed O Mohamed-Balghata, MD, Principal investigator, Hospital Universitario Ciudad de Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01437241
- Sponsor's protocol ID
- LFL-ETR-2010-01
- Status last verified
- Oct 2011
- First submitted
- 17 Sep 2011
- Last updated
- 1 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lopez-Cortes LF, Viciana P, Giron-Gonzalez JA, Romero-Palacios A, Marquez-Solero M, Martinez-Perez MA, Lopez-Ruz MA, de la Torre-Lima J, Tellez-Perez F, Delgado-Fernandez M, Garcia-Lazaro M, Lozano F, Mohamed-Balghata MO; Sociedad Andaluza de Enfermedades Infecciosas. Clinical and virological efficacy of etravirine plus two active Nucleos(t)ide analogs in an heterogeneous HIV-infected population. PLoS One. 2014 May 16;9(5):e97262. doi: 10.1371/journal.pone.0097262. eCollection 2014.
PubMed 24836963
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virological Efficacy and Safety of Etravirine Plus 2 Active Nucleos(t)Ide Reverse-transcriptase Inhibitors (NRTIs) in HIV-1-infected Patients
- ClinicalTrials.gov ID
- NCT01437241
- Acronym / sponsor ID
- LFL-ETR-2010-01
- Conditions
- HIV-1-infection
- Keywords
- HIV-infection, Etravirine, Treatment, Non-nucleoside reverse-transcriptase inhibitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Hospitales Universitarios Virgen del RocíoUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 20 Sep 2011 (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 virological and clinical efficacy of etravirine plus 2 active nucleos(t)ide reverse-transcriptase inhibitors (NRTIs) in HIV-infected patients. Additionally, the safety of these regimens, specially lipid profiles, will be assessed.
Detailed description
Methods: prospective, single arm multicenter clinical trial without entry restrictions on plasma HIV-RNA (VL) or CD4 with a planned duration of 52 weeks.
The primary clinical endpoint is the percentage of subjects with therapeutic success on etravirine 400 mg/day (200 mg bid or 400 mg qd) plus 2 active NRTIs after 12 months. Efficacy data will be analyzed by on-treatment and by intention-to-treat analyses (noncomplete/missing equals failure), considering treatment failure as either treatment interruption whatever the reason (adverse events, death, or loss to follow-up) or virological failure, defined as inability to suppress the VL to less than 50 copies/ml after 24 weeks on treatment or a confirmed VL of more than 200 copies/ml in patients who had previously achieved a viral suppression or had an undetectable viral load at inclusion.
Patients missing two consecutive scheduled visits were considered lost to follow-up. The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results.
NRTIs prescribed as part of HAART were selected by the responsible physicians on the basis of previous antiretroviral treatments and/or genotypic resistance testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| etravirine | – | –Antiretroviral regimens based on etravirine plus 2 active nucleos(t)ide reverse-transcriptase inhibitors (NRTIs) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-infected patients who strated an antirretroviral regimen based on etravirine plus 2 NRTIs between January 2009 and June 2010
Key inclusion criteria (1 listed)
- Older than 18 years, starting an antiretroviral regimen based on etravirine plus 2 NRTIs between January 2009 and June 2010, evidence of activity of all drugs on the basis of treatment history and genotypic resistance testing, informed consent, and at least one follow-up visit.
Key exclusion criteria (1 listed)
- Genotypic resistance tests with evidence of resistance to any drug used, and concomitant use of drugs with potentially adverse interactions with etravirine pharmacokinetics, such as rifampin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Virological efficacy
Time frame: 52 weeks
Percentage of subjects with therapeutic success at month 12. Efficacy data will be analyzed by on-treatment and by intention-to-treat considering treatment failure as either treatment interruption whatever the reason (adverse events, death, or loss to follow-up) or virological failure, defined as inability to suppress the VL to <50 copies/ml after 24 weeks or a confirmed VL of >200 copies/ml in patients who had previously achieved a viral suppression or had an undetectable viral load at inclusion. Patients missing two consecutive scheduled visits were considered lost to follow-up.
1 secondary outcome
Safety
Time frame: 52 weeks
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 1 Nov 2011.
- Derived from this study: PubMed 24836963Lopez-Cortes LF, Viciana P, Giron-Gonzalez JA, Romero-Palacios A, Marquez-Solero M, Martinez-Perez MA, Lopez-Ruz MA, de la Torre-Lima J, Tellez-Perez F, Delgado-Fernandez M, Garcia-Lazaro M, Lozano F, Mohamed-Balghata MO; Sociedad Andaluza de Enfermedades Infecciosas. Clinical and virological efficacy of etravirine plus two active Nucleos(t)ide analogs in an heterogeneous HIV-infected population. PLoS One. 2014 May 16;9(5):e97262. doi: 10.1371/journal.pone.0097262. eCollection 2014.
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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.
Luis F Lopez-Cortes, MD, PhD. principal investigator
Hospitales Universitarios Virgen del Rocío
Francisco Tellez-Perez, MD principal investigator
Hospital de la Linea de la Concepcion
Antonio Vergara-Campos, MD, PhD. principal investigator
Hospital Universitario de Puerto Real
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1-infection, run by Hospitales Universitarios Virgen del Rocío at 11 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 1 inclusion and 1 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 1 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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.
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?
Virological efficacy (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01437241, which also lists 1 linked publication.
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 1 Nov 2011.