HIV InfectionsPhase 2/3TROPISMVCNCT01060618
Double-method Comparative Study in Order to Predict the Use of Co-receptors From Type 1 HIV: Phenotypic Study (Trofile ESTA®) and Virologic Response to a CCR5 Antagonist in the Short Term
A Phase 2/3 study testing Maraviroc + Trofile ESTA® (diagnose test) in people with HIV Infections, run by Asociacion para el Estudio de las Enfermedades Infecciosas at 4 sites in Spain.
Trial summary
The summary of the Study is to compare two methods in order to predict how the 1-HIV will use a co-receptor: the use of an accredited test (TROFILE ESTA®) and the viral response to a CCR5 antagonist in the short term. 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?
- Maraviroc + Trofile ESTA® (diagnose test)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 4 sitesSpain
- Study dates
- May 2009to Dec 2011
- Phase
- Phase 2/3
- 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 willing to give, sign and date the Informed Consent Form to participate in the Study and to donate their samples for cell and molecular Studies, after receiving the appropriate information about the Study design, the main objective of the Study and the potential risks.
- Patients aged >18.
- Patients with chronic HIV infection
- Patients with no previous HAART (naïve patients).
- Patients that do not meet HAART starting criteria.
- Viral load >1.000 HIV RNA copies/mL
- Patients able to understand the Study objectives and able to perform frequent visits to the Study Site.
Who cannot join
- Prior HAART (regardless of the HAART type).
- Pregnancy or willingness to get pregnant during the Study.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 280007
Hospital Ramón y Cajal
Madrid, Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Hospital Universitario La Paz
Madrid, Madrid, 28046
About this study
Official title: Estudio Comparativo de Dos métodos Para Predecir el Uso de Co-receptores Por el Virus de la Inmunodeficiencia 1 (HIV-1): el Ensayo fenotípico (Trofile ESTA®) y la Respuesta virológica a Corto Plazo a un Antagonista de CCR5
The summary of the Study is to compare two methods in order to predict how the 1-HIV will use a co-receptor: the use of an accredited test (TROFILE ESTA®) and the viral response to a CCR5 antagonist in the short term.
- Conditions
- HIV Infections
- Being tested
- Maraviroc + Trofile ESTA® (diagnose test)
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maraviroc + Trofile ESTA® (diagnose test)Other
The Trofile ESTA® will be performed in those patients and once the results are obtained (within one month approximately), the patients will be treated with the medication Maraviroc
| Study group | Role | What they receive |
|---|---|---|
| Maraviroc + Trofile ESTA® | Experimental | the patients have the Trofile ESTA® test performed and sent for evaluation. Once the results are obtained (about 1 month later), the patients take the medication Maraviroc during ten days. The viral load assessment throughout the Study help to make a prediction to assess if the patients would have a positive response Vs. CCR5 antagonist of a negative response Receives: Other: Maraviroc + Trofile ESTA® (diagnose test) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if there is a correlation between the Trofile ESTA® test for viral tropism and the viral load reduction after a short treatment with maraviroc in naïve patients (patients with no previous HAART)
Measured: 10 days of treatment per patient
Secondary outcomes (5)
To establish a viral load reduction cut point, which would differentiate R5-tropic virus from non-R5 tropic virus(X4/dual/mixed).
Measured: 1 month per patient
To assess the viral response to a CCR5 antagonist according to the viral tropism identified in the phenotypic Study.
Measured: 1 month per patient
Safety assessment throughout the Study
Measured: 12 months
Maraviroc effects assessment in the drug-resistance evolution in naïve patients
Measured: 12 months
Tropism changes assessment since the Screening period
Measured: 1 month per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startMay 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociacion para el Estudio de las Enfermedades Infecciosas
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Santiago Moreno, MD, Principal investigator, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060618
- Sponsor's protocol ID
- TROPISMVC
- Other IDs
- 2008-007208-28, 2008
- Acronym
- TROPISMVC
- Status last verified
- Feb 2013
- First submitted
- 31 Jan 2010
- Last updated
- 28 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Cascajero A, Rastrojo A, Diez-Fuertes F, Hernandez-Novoa B, Aguado B, Moreno S, Alcami J, Perez-Olmeda M. Deep-Sequencing Analysis of the Dynamics of HIV-1 Quasiespecies in Naive Patients during a Short Exposure to Maraviroc. J Virol. 2018 May 14;92(11):e00390-18. doi: 10.1128/JVI.00390-18. Print 2018 Jun 1.
PubMed 29563289Hernandez-Novoa B, Madrid-Elena N, Dronda F, Perez-Elias MJ, Casado JL, Perez-Molina JA, Moreno A, Estebanez M, Gonzalez J, Zamora J, Moreno S. Virological response to short-course maraviroc monotherapy does not predict viral tropism in HIV-1-infected treatment-naive patients. J Antimicrob Chemother. 2014 Jul;69(7):1916-9. doi: 10.1093/jac/dku059. Epub 2014 Mar 12.
PubMed 24623833
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudio Comparativo de Dos métodos Para Predecir el Uso de Co-receptores Por el Virus de la Inmunodeficiencia 1 (HIV-1): el Ensayo fenotípico (Trofile ESTA®) y la Respuesta virológica a Corto Plazo a un Antagonista de CCR5
- ClinicalTrials.gov ID
- NCT01060618
- Acronym / sponsor ID
- TROPISMVC / TROPISMVC
- Conditions
- HIV Infections
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Asociacion para el Estudio de las Enfermedades InfecciosasResearch network
- Study start
- May 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Feb 2010 (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 summary of the Study is to compare two methods in order to predict how the 1-HIV will use a co-receptor: the use of an accredited test (TROFILE ESTA®) and the viral response to a CCR5 antagonist in the short term.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maraviroc + Trofile ESTA® | Experimental | Other: Maraviroc + Trofile ESTA® (diagnose test)the patients have the Trofile ESTA® test performed and sent for evaluation. Once the results are obtained (about 1 month later), the patients take the medication Maraviroc during ten days. The viral load assessment throughout the Study help to make a prediction to assess if the patients would have a positive response Vs. CCR5 antagonist of a negative response |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients willing to give, sign and date the Informed Consent Form to participate in the Study and to donate their samples for cell and molecular Studies, after receiving the appropriate information about the Study design, the main objective of the Study and the potential risks.
- Patients aged >18.
- Patients with chronic HIV infection
- Patients with no previous HAART (naïve patients).
- Patients that do not meet HAART starting criteria.
Key exclusion criteria (2 listed)
- Prior HAART (regardless of the HAART type).
- Pregnancy or willingness to get pregnant during the Study.
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 |
|---|---|---|
| Maraviroc + Trofile ESTA® (diagnose test)The Trofile ESTA® will be performed in those patients and once the results are obtained (within one month approximately), the patients will be treated with the medication Maraviroc | Other | Maraviroc + Trofile ESTA® |
Primary outcome
To determine if there is a correlation between the Trofile ESTA® test for viral tropism and the viral load reduction after a short treatment with maraviroc in naïve patients (patients with no previous HAART)
Time frame: 10 days of treatment per patient
5 secondary outcomes
To establish a viral load reduction cut point, which would differentiate R5-tropic virus from non-R5 tropic virus(X4/dual/mixed).
Time frame: 1 month per patient
To assess the viral response to a CCR5 antagonist according to the viral tropism identified in the phenotypic Study.
Time frame: 1 month per patient
Safety assessment throughout the Study
Time frame: 12 months
Maraviroc effects assessment in the drug-resistance evolution in naïve patients
Time frame: 12 months
Tropism changes assessment since the Screening period
Time frame: 1 month per patient
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 28 Feb 2013.
- Derived from this study: PubMed 29563289Cascajero A, Rastrojo A, Diez-Fuertes F, Hernandez-Novoa B, Aguado B, Moreno S, Alcami J, Perez-Olmeda M. Deep-Sequencing Analysis of the Dynamics of HIV-1 Quasiespecies in Naive Patients during a Short Exposure to Maraviroc. J Virol. 2018 May 14;92(11):e00390-18. doi: 10.1128/JVI.00390-18. Print 2018 Jun 1.
- Derived from this study: PubMed 24623833Hernandez-Novoa B, Madrid-Elena N, Dronda F, Perez-Elias MJ, Casado JL, Perez-Molina JA, Moreno A, Estebanez M, Gonzalez J, Zamora J, Moreno S. Virological response to short-course maraviroc monotherapy does not predict viral tropism in HIV-1-infected treatment-naive patients. J Antimicrob Chemother. 2014 Jul;69(7):1916-9. doi: 10.1093/jac/dku059. Epub 2014 Mar 12.
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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.
Santiago Moreno, MD principal investigator
Hospital Universitario Ramon y Cajal
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Maraviroc + Trofile ESTA® (diagnose test) in people with HIV Infections, run by Asociacion para el Estudio de las Enfermedades Infecciosas at 4 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 7 inclusion and 2 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 28 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To determine if there is a correlation between the Trofile ESTA® test for viral tropism and the viral load reduction after a short treatment with maraviroc in naïve patients (patients with no previous HAART) (time frame: 10 days of treatment per patient). 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 NCT01060618, which also lists 2 linked publications.
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 28 Feb 2013.