HIV-1 Adults PatientsPhase 4TERCETONCT01013987
Maraviroc (Celsentri) With Raltegravir and Darunavir/Ritonavir for the Treatment of Triple Class Failure in Adult HIV-1 Infected Patients
A Phase 4 study testing maraviroc, Raltegravir and Darunavir/ritonavir in people with HIV-1 Adults Patients and AIDS, run by Fundación Huésped at 1 site in Argentina.
Trial summary
Phase 4, single arm, open label study designed to compare the safety and efficacy of antiviral activity and immunological effect of Maraviroc in combination with Raltegravir and Darunavir/Ritonavir for treatment of triple class failure in adult HIV-1 infected subjects. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- HIV-1 Adults Patients, AIDS, Triple Class Failure
- What is being tested?
- maraviroc, Raltegravir and Darunavir/ritonavir
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteArgentina
- Study dates
- Feb 2010to not given
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject is at least 21 years of age.
- Patient with documented HIV-1 infection defined as a positive ELISA plus a confirmatory Western Blot; or alternatively, a plasma HIV- RNA ≥10,000 copies/ml ever documented.
- Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed.
- Subject agrees not to take any medication during the study, including over the counter medicines, vitamins, minerals, herbal preparations, alcohol or recreational drugs without the approval of the trial physician.
- Documented HIV RNA >500 copies/ml
- Subject triple class antiretroviral failure (NRTI, NNRTI, PI)
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- Subject naïve to CCR5-inhibitors, integrase-inhibitors and darunavir.
- Subjects can comply with protocol requirements.
- Subject's general medical condition, in the investigator's opinion, does not interfere with assessments and completion of the trial.
- If female, subject must be either postmenopausal for at least one year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or she must:
- use of a double birth control method that includes at least one barrier method, that is acceptable to both the subject and investigator, and
- has a urine pregnancy test performed at the Screening Visit and on Baseline, and results of both tests must be negative.
- continue practicing birth control methods for at least 30 days after the end of the treatment period.
- Subject present R5 HIV1 at Screening, verified by Trofile Essay by Monogram Bioscience.
Who cannot join
- Evidence of resistance against Maraviroc, Raltegravir, Darunavir/Ritonavir, based on the resistance test performed at Screening.
- Previously documented HIV-2 infection.
- Use of disallowed concomitant therapy listed in guidelines for use of each drug.
- Patient has a current (active) diagnosis of acute hepatitis due to any cause OR chronic hepatitis B and/or C WITH aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)>5 x upper limit of normal (ULN) AND/OR is likely to require treatment in the next year.
- Any active clinically significant disease (e.g. tuberculosis, cardiac disfunction, pancreatitis) or findings during screening of medical history or physical examination that, in the investigator´s opinion, would compromise the subject´s safety or outcome of the trial or adherence to the trial protocol.
- Subject has a currently active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV infection 1993) within 30 days of screening. Subjects who are on stable maintenance therapy for an opportunistic infection may be enrolled.
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- Life expectancy < 1 year according to the judgment of the investigator.
- Screening laboratory analysis show any of the following abnormal laboratory results:
- Hemoglobin < 8.0 g/dL
- Absolute neutrophil count < 750 cells/µL
- Platelet count < 50,000 mm3
- Subject enrolled in other clinical trials that include any blood sampling, specimen collection, or other interventional procedure. Concurrent participation in non-interventional observational trials
- Use of any investigational agents within 30 days prior to screening.
- Use of immunosuppressive drugs, cytokine inhibitors or other cytokines in the last year.
- Any condition (including but not limited to alcohol and drug use) which in the opinion of the investigator, could compromise the subject's safety or adherence to the protocol;.
- Subject is pregnant or breast-feeding
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Fundación Huésped
Ciudad de Buenos Aires, C1202ABB
María C. Magneres, MD, 54-11-4981-7777 ext. 114, maria.magneres@huesped.org.ar
Patricia Luz Patterson, MD, 54-11-4981-7777 ext. 114, patricia.patterson@huesped.org.ar
About this study
Official title: A Phase 4, Single Arm, Open Label, Pilot Study of Maraviroc (Celsentri) in Combination With Raltegravir and Darunavir/Ritonavir for the Treatment of Triple Class Failure in Adult HIV-1 Infected Patients.
Phase 4, single arm, open label study designed to compare the safety and efficacy of antiviral activity and immunological effect of Maraviroc in combination with Raltegravir and Darunavir/Ritonavir for treatment of triple class failure in adult HIV-1 infected subjects.
The purpose of this study is to look at the safety and efficacy of a combination of 3 new antiretroviral drugs: maraviroc, darunavir and raltegravir in patients who have multi-resistant viruses and limited treatment options. Patients will undergo treatment for 48 weeks; safety and virological efficacy will be preliminary evaluated at weeks 16 and 24.
Read the detailed description
This is a Phase 4, single arm, open-label, study designed to demonstrate the safety, tolerability, efficacy, antiviral and immunological activity of Maraviroc in combination with Raltegravir and Darunavir/Ritonavir in patients with limited to no treatment option in HIV-1 infected subjects ≥ 21 years old.
The trial population will comprise 60 HIV-infected subjects with history of triple class antiretroviral failure, naïve to CCR5-inhibitors, integrase-inhibitors and darunavir will be evaluated. Single arm, stratified according to plasma viral load at screening (> or < 100,000 copies/ml).
Those with evidence of R5 viruses and susceptibility to darunavir in the resistance testing analysis, plus history of failure to NRTIs, NNRTIs and at least one PI, plus a genotype analysis showing evidence of resistance to NRTIs (at least 2 TAMS and/or Q151M and or 69ss), resistance to PIs (at least 2 major mutations), will start a regimen of maraviroc, raltegravir and ritonavir boosted darunavir.
This trial will consist of a screening period of up to 6 weeks, a 48-week treatment period, with interim analysis at 16 and 24 weeks. Followed by a 4-week post-treatment follow-up (FU) period.
Virologic response, CD4 count change, clinical outcomes and safety will be followed throughout the study.
- Conditions
- HIV-1 Adults Patients, AIDS, Triple Class Failure
- Being tested
- maraviroc, Raltegravir, Darunavir/ritonavir
- Keywords
- HIV-1, triple class failure, Maraviroc, Raltegravir, Darunavir/ritonavir, Maraviroc with raltegravir and darunavir/ritonavir
- 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.
maravirocDrug
Also called Celsentri
maraviroc: one 150 mg pill twice daily
RaltegravirDrug
Also called Issentres
raltegravir : one 400 mg pill twice daily
Darunavir/ritonavirDrug
- darunavir : two 300 mg pills twice daily with meal
- ritonavir: one 100 mg pill twice daily with meal
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with HIV RNA levels of less than 50 copies/ml in an intent to treat analysis at week 24
Measured: week 24
Secondary outcomes (1)
Proportion of patients with HIV RNA levels of less than 50 copies/ml at week 24 and with HIV RNA levels of less than 400 copies/ ml at weeks 24 and 48.
Measured: week 24 and week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2009 (estimated)
- Study startFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1 Adults PatientsStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Huésped
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01013987
- Sponsor's protocol ID
- TERCETO
- Acronym
- TERCETO
- Status last verified
- Nov 2009
- First submitted
- 13 Nov 2009
- Last updated
- 10 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Single Arm, Open Label, Pilot Study of Maraviroc (Celsentri) in Combination With Raltegravir and Darunavir/Ritonavir for the Treatment of Triple Class Failure in Adult HIV-1 Infected Patients.
- ClinicalTrials.gov ID
- NCT01013987
- Acronym / sponsor ID
- TERCETO / TERCETO
- Conditions
- HIV-1 Adults Patients, AIDS, Triple Class Failure
- Keywords
- HIV-1, triple class failure, Maraviroc, Raltegravir, Darunavir/ritonavir, Maraviroc with raltegravir and darunavir/ritonavir
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fundación HuéspedUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Feb 2010
- First posted
- 16 Nov 2009 (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.
Phase 4, single arm, open label study designed to compare the safety and efficacy of antiviral activity and immunological effect of Maraviroc in combination with Raltegravir and Darunavir/Ritonavir for treatment of triple class failure in adult HIV-1 infected subjects.
The purpose of this study is to look at the safety and efficacy of a combination of 3 new antiretroviral drugs: maraviroc, darunavir and raltegravir in patients who have multi-resistant viruses and limited treatment options. Patients will undergo treatment for 48 weeks; safety and virological efficacy will be preliminary evaluated at weeks 16 and 24.
Detailed description
This is a Phase 4, single arm, open-label, study designed to demonstrate the safety, tolerability, efficacy, antiviral and immunological activity of Maraviroc in combination with Raltegravir and Darunavir/Ritonavir in patients with limited to no treatment option in HIV-1 infected subjects ≥ 21 years old.
The trial population will comprise 60 HIV-infected subjects with history of triple class antiretroviral failure, naïve to CCR5-inhibitors, integrase-inhibitors and darunavir will be evaluated. Single arm, stratified according to plasma viral load at screening (> or < 100,000 copies/ml).
Those with evidence of R5 viruses and susceptibility to darunavir in the resistance testing analysis, plus history of failure to NRTIs, NNRTIs and at least one PI, plus a genotype analysis showing evidence of resistance to NRTIs (at least 2 TAMS and/or Q151M and or 69ss), resistance to PIs (at least 2 major mutations), will start a regimen of maraviroc, raltegravir and ritonavir boosted darunavir.
This trial will consist of a screening period of up to 6 weeks, a 48-week treatment period, with interim analysis at 16 and 24 weeks. Followed by a 4-week post-treatment follow-up (FU) period.
Virologic response, CD4 count change, clinical outcomes and safety will be followed throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female subject is at least 21 years of age.
- Patient with documented HIV-1 infection defined as a positive ELISA plus a confirmatory Western Blot; or alternatively, a plasma HIV- RNA ≥10,000 copies/ml ever documented.
- Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed.
- Subject agrees not to take any medication during the study, including over the counter medicines, vitamins, minerals, herbal preparations, alcohol or recreational drugs without the approval of the trial physician.
- Documented HIV RNA >500 copies/ml
Key exclusion criteria (16 listed)
- Evidence of resistance against Maraviroc, Raltegravir, Darunavir/Ritonavir, based on the resistance test performed at Screening.
- Previously documented HIV-2 infection.
- Use of disallowed concomitant therapy listed in guidelines for use of each drug.
- Patient has a current (active) diagnosis of acute hepatitis due to any cause OR chronic hepatitis B and/or C WITH aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)>5 x upper limit of normal (ULN) AND/OR is likely to require treatment in the next year.
- Any active clinically significant disease (e.g. tuberculosis, cardiac disfunction, pancreatitis) or findings during screening of medical history or physical examination that, in the investigator´s opinion, would compromise the subject´s safety or outcome of the trial or adherence to the trial protocol.
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 |
|---|---|---|
| maravirocAlso: Celsentrimaraviroc: one 150 mg pill twice daily | Drug | – |
| RaltegravirAlso: Issentresraltegravir : one 400 mg pill twice daily | Drug | – |
| Darunavir/ritonavir* darunavir : two 300 mg pills twice daily with meal * ritonavir: one 100 mg pill twice daily with meal | Drug | – |
Primary outcome
Proportion of patients with HIV RNA levels of less than 50 copies/ml in an intent to treat analysis at week 24
Time frame: week 24
1 secondary outcome
Proportion of patients with HIV RNA levels of less than 50 copies/ml at week 24 and with HIV RNA levels of less than 400 copies/ ml at weeks 24 and 48.
Time frame: week 24 and week 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2010.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing maraviroc, Raltegravir and Darunavir/ritonavir in people with HIV-1 Adults Patients and AIDS, run by Fundación Huésped at 1 site in Argentina.
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 14 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 10 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alejandro Krolewiecki, MD (54-11-4981-7777 ext. 114, alekrol@huesped.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with HIV RNA levels of less than 50 copies/ml in an intent to treat analysis at week 24 (time frame: week 24). 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 10 Feb 2010.