HIVPhase 2NNNBNCT01291459
Pilot Study of Maraviroc/Raltegravir for Naive HIV-1 Patients
A Phase 2 study testing MVC/RAL/FTC/TDF followed by Maraviroc/Raltegravir in people with HIV, run by Association Pour la Recherche en Infectiologie at 12 sites in France.
Trial summary
Background and Rationale Raltegravir and Maraviroc, the first in class of 2 new families of antiretroviral drugs have demonstrated a high potency in treatment experienced and naive patients. Both drugs appeared well tolerated with low metabolic toxicity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- MVC/RAL/FTC/TDF followed by Maraviroc/Raltegravir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 12 sitesFrance
- Study dates
- Sep 2011to Dec 2015
- Phase
- Phase 2
- 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
- Age ≥ 18 years old at the run-in visit
- HIV-1 infection
- Antiretroviral treatment-naive
- CD4 ≥ 200 /mm3
- HIV- RNA ≥ 1000 copies/ml
- HIV-RNA ≤ 100,000 copies/ml
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- Antiretroviral therapy is indicated according to current guidelines
- CCR5-tropic virus according to the Trofile ES® assayGeno2Pheno algorithm using a predefined false positive rate of 20%
- No significant NRTI, NNRTI or PI resistance mutation
- Freely-given, written, informed consent obtained; the patient and investigator have signed the consent form (by the latest on the day of the run-in visit and before performing any examinations required by the trial)
- Patient covered by a French national health insurance scheme
Who cannot join
- Women of child-bearing potential not using effective contraception (barrier method)
- Pregnant or breast-feeding women
- Patients under the age of 18 years
- Patients deprived of liberty by a judicial or administrative, hospitalized patients without consent, patients admitted to a health or social purposes other than research
- Persons major subject of a measure of legal protection or unable to consent
- Previous antiretroviral therapy (with the exception of post-exposure prophylaxis if HIV serology is negative > 3 months after the last dose of antiretroviral drugs)
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- CXCR4-tropic virus, dual/mixed-tropic virus or undetermined tropism on screening
- Presence of significant NRTI, NNRTI or PI resistance mutation(s)
- Infection or co-infection with HIV-2, or group O or N HIV-1
- Acute phase of an opportunistic infection
- Undergoing treatment for tuberculosis
- Undergoing chemotherapy and/or radiotherapy for neoplastic disease
- Decompensated cirrhosis (Child-Pugh class B or C)
- HIV-HBV co-infection. Patients with HIV-HCV co-infection are permitted to participate in the absence of decompensated cirrhosis (Child-Pugh class B or C), of hepatocytolysis > 3 times the upper limit of normal and if treatment for HCV during the ensuing 12 months is not indicated. PAtients with occult HBV are excluded.( positive AcHBc, negative AcHBs, negative AgHBs, positive HBV DNA)
- Co-administration of prohibited treatments (see the SPCs of each product) Laboratory parameters: Haemoglobin < 7g/dl, neutrophil count < 500/mm3, platelet count < 50,000/mm3, creatinine clearance < 50 ml/min, alkaline phosphatase, AST, ALT or bilirubin ≥ 3 times upper limit of normal
- Patient refuses to participate
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Cannes hosipital
Cannes, 06400
CHU
Clermont-Ferrand, 63003
Frejus hospital
Fréjus, 83608
Edourad Herriot hospital
Lyon, 69003
Croix Rousse hospital
Lyon, 69004
Ste MArguerite Hospital
Marseille, 13009
Conception hospital
Marseille, 13385
Hotel Dieu hospital
Nantes, 44093
Hopital l'Archet 1
Nice, 06202
St Louis Hospital
Paris, 75010
Pitie Salpetriere Hospital
Paris, 75013
Nord Hospital
Saint-Etienne, 42277
About this study
Official title: Phase II Pilot Study of Simplification to Maraviroc - Raltegravir Dual Therapy After 6 Months of Maraviroc - Raltegravir - Tenofovir - Emtricitabine Quadruple Therapy in ARV Treatment-naive, HIV-1-infected Patients With CCR5- Virus
Background and Rationale
Raltegravir and Maraviroc, the first in class of 2 new families of antiretroviral drugs have demonstrated a high potency in treatment experienced and naive patients. Both drugs appeared well tolerated with low metabolic toxicity. No data are currently available concerning the combination of these 2 drugs.
Hypothesis
Maraviroc + Raltegravir should be potent enough to maintain virological efficacy in naive patients infected by CCR5 HIV-1 previously treated for 6 months with a Maraviroc-Raltegravir-Tenofovir-Emtricitabine combination.
Read the detailed description
Objectives:
- To establish the ability of a Maraviroc-Raltegravir combination to maintain HIV-1 viral load < 50 copies/ml at week 48 in naive patients infected by CCR5 HIV-1, following an initial 6 month phase of Maraviroc-Raltegravir-Tenofovir-Emtricitabine combination (Intent to treat and strategy analysis)
- To study CD4 progression from baseline to week 48
- To study the time to virological failure during the simplification phase of the study (from week 24 to week 48)
- To study the proportion of patients with HIV RNA < 50 copies/ml at each time point
- To study the kinetics of viral load decrease from baseline to week 12
- To study the kinetics of proviral DNA decrease from baseline to week 12, 24, 36 and 48
- To study the clinical and biological tolerance of Maraviroc-Raltegravir combination through week 48
Study Design/ Clinical Plan
Pilot, multicenter, national, uncontrolled study
- Conditions
- HIV
- Being tested
- MVC/RAL/FTC/TDF followed by Maraviroc/Raltegravir
- Keywords
- HIV, naive patients, maraviroc, raltegravir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVC/RAL/FTC/TDF followed by Maraviroc/RaltegravirDrug
Also called Maraviroc, Raltegravir, Emtricitabine, Tenofovir
MVC/RAL/FTC/TDF 24W followed by MVC/RAL until W48.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | Maraviroc/raltegravir/emtricitabine/tenofovir 24 weeks followed by Maraviroc/Raltegravir 24 weeks Receives: Drug: MVC/RAL/FTC/TDF followed by Maraviroc/Raltegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV-1 viral load
measure of HIV viral load at 48 weeks of treatment for all patients
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association Pour la Recherche en Infectiologie
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Laurent COTTE, Association Pour la Recherche en Infectiologie
- Investigators
- Laurent COTTE, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291459
- Sponsor's protocol ID
- 2009/HD/01
- Acronym
- NNNB
- Status last verified
- Dec 2015
- First submitted
- 26 Jan 2011
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Pilot Study of Simplification to Maraviroc - Raltegravir Dual Therapy After 6 Months of Maraviroc - Raltegravir - Tenofovir - Emtricitabine Quadruple Therapy in ARV Treatment-naive, HIV-1-infected Patients With CCR5- Virus
- ClinicalTrials.gov ID
- NCT01291459
- Acronym / sponsor ID
- NNNB / 2009/HD/01
- Conditions
- HIV
- Keywords
- HIV, naive patients, maraviroc, raltegravir
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Association Pour la Recherche en InfectiologieUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 8 Feb 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.
Background and Rationale
Raltegravir and Maraviroc, the first in class of 2 new families of antiretroviral drugs have demonstrated a high potency in treatment experienced and naive patients. Both drugs appeared well tolerated with low metabolic toxicity. No data are currently available concerning the combination of these 2 drugs.
Hypothesis
Maraviroc + Raltegravir should be potent enough to maintain virological efficacy in naive patients infected by CCR5 HIV-1 previously treated for 6 months with a Maraviroc-Raltegravir-Tenofovir-Emtricitabine combination.
Detailed description
Objectives:
- To establish the ability of a Maraviroc-Raltegravir combination to maintain HIV-1 viral load < 50 copies/ml at week 48 in naive patients infected by CCR5 HIV-1, following an initial 6 month phase of Maraviroc-Raltegravir-Tenofovir-Emtricitabine combination (Intent to treat and strategy analysis)
- To study CD4 progression from baseline to week 48
- To study the time to virological failure during the simplification phase of the study (from week 24 to week 48)
- To study the proportion of patients with HIV RNA < 50 copies/ml at each time point
- To study the kinetics of viral load decrease from baseline to week 12
- To study the kinetics of proviral DNA decrease from baseline to week 12, 24, 36 and 48
- To study the clinical and biological tolerance of Maraviroc-Raltegravir combination through week 48
Study Design/ Clinical Plan
Pilot, multicenter, national, uncontrolled study
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Drug: MVC/RAL/FTC/TDF followed by Maraviroc/RaltegravirMaraviroc/raltegravir/emtricitabine/tenofovir 24 weeks followed by Maraviroc/Raltegravir 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years old at the run-in visit
- HIV-1 infection
- Antiretroviral treatment-naive
- CD4 ≥ 200 /mm3
- HIV- RNA ≥ 1000 copies/ml
Key exclusion criteria (16 listed)
- Women of child-bearing potential not using effective contraception (barrier method)
- Pregnant or breast-feeding women
- Patients under the age of 18 years
- Patients deprived of liberty by a judicial or administrative, hospitalized patients without consent, patients admitted to a health or social purposes other than research
- Persons major subject of a measure of legal protection or unable to consent
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 |
|---|---|---|
| MVC/RAL/FTC/TDF followed by Maraviroc/RaltegravirAlso: Maraviroc, Raltegravir, Emtricitabine, TenofovirMVC/RAL/FTC/TDF 24W followed by MVC/RAL until W48. | Drug | single arm |
Primary outcome
HIV-1 viral load
Time frame: 48 weeks
measure of HIV viral load at 48 weeks of treatment for all patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2015.
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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.
Laurent COTTE, MD principal investigator
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MVC/RAL/FTC/TDF followed by Maraviroc/Raltegravir in people with HIV, run by Association Pour la Recherche en Infectiologie at 12 sites in France.
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 11 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 30 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
HIV-1 viral load (time frame: 48 weeks). 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 30 Dec 2015.