HIV InfectionPhase 2145 MARIMUNONCT00944541
Evaluation of Maraviroc Intensification in HIV Infected Patients With Insufficient Immune Restoration
A Phase 2 study testing maraviroc in people with HIV Infection and HIV Infections, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.
Trial summary
This pilot study aims to evaluate Maraviroc intensification strategy during 24 weeks in HIV infected patients under efficient (CV< 50 cp/mL), controlled antiretroviral therapy (≥ 6 months) and uncompleted immune restoration (CD4<350 cells/mL and CD4 earning <100 cells/mL during last 24 months). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection, HIV Infections
- What is being tested?
- maraviroc
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2009to Jan 2011
- 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
- HIV-1 infection
- maraviroc-naives patients
- CD4 less than 350 cells/mm3
- viral load less than 50 cp/mL and CD4 earning less than 100 cells/mm3 during last 24 months
Who cannot join
- HIV-2 infection
- X4 tropism at inclusion
- pregnancy and breast feeding
- interferon, immunomodulatory drugs treatment or anti-HIV vaccines and chemotherapy
- hypersensibility of peanut or soya
Trial locations and contacts
1 site in 1 country.
France1 site
French National Agency for Research on AIDS and Viral Hepatits
Paris, 75013
About this study
Official title: Pilot Study Evaluating Maraviroc (Celsentri®)Intensification Benefit in HIV Infected Patients Presenting Insufficient Immune Restoration Despite Controlled Viral Load With Antiretroviral Treatment. ANRS 145 MARIMUNO
This pilot study aims to evaluate Maraviroc intensification strategy during 24 weeks in HIV infected patients under efficient (CV< 50 cp/mL), controlled antiretroviral therapy (≥ 6 months) and uncompleted immune restoration (CD4<350 cells/mL and CD4 earning <100 cells/mL during last 24 months).
The study will include 60 patients whose follow up is carried out for 48 weeks. recruitment period will be maintained for 12 months.
- Conditions
- HIV Infection, HIV Infections
- Being tested
- maraviroc
- Keywords
- maraviroc, immune restoration, treatment intensification
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maravirocDrug
Also called Celsentri
maraviroc 150 mg or 300 mg or 600 mg twice a day for 24 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of maraviroc intensification during 24 weeks in HIV infected patients with insufficient immune restoration despite controlled viral load
Measured: immunologic benefit at week 24
Secondary outcomes (1)
Maraviroc efficacy at W24 (virological and immunological efficacy); Durability of maraviroc efficacy between W24 & W36; Cmin of maraviroc and other molecules at W4,12,24; Evaluation of the safety of maraviroc between W0 and W36.
Measured: immuno-virologic evolution between week 0 and week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionAug 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Sponsor type
- Other government
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Lise CUZIN, MD, Principal investigator, CHU Purpan - Toulouse (France)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944541
- Sponsor's protocol ID
- ANRS 145 MARIMUNO
- Other IDs
- 2009-011171-76, 2009
- Acronym
- 145 MARIMUNO
- Status last verified
- Dec 2011
- First submitted
- 22 Jul 2009
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating Maraviroc (Celsentri®)Intensification Benefit in HIV Infected Patients Presenting Insufficient Immune Restoration Despite Controlled Viral Load With Antiretroviral Treatment. ANRS 145 MARIMUNO
- ClinicalTrials.gov ID
- NCT00944541
- Acronym / sponsor ID
- 145 MARIMUNO / ANRS 145 MARIMUNO
- Conditions
- HIV Infection, HIV Infections
- Keywords
- maraviroc, immune restoration, treatment intensification
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- French National Agency for Research on AIDS and Viral HepatitisOther government
- Collaborators
- Pfizer
- Study start
- Sep 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 23 Jul 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.
This pilot study aims to evaluate Maraviroc intensification strategy during 24 weeks in HIV infected patients under efficient (CV< 50 cp/mL), controlled antiretroviral therapy (≥ 6 months) and uncompleted immune restoration (CD4<350 cells/mL and CD4 earning <100 cells/mL during last 24 months).
The study will include 60 patients whose follow up is carried out for 48 weeks. recruitment period will be maintained for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV-1 infection
- maraviroc-naives patients
- CD4 less than 350 cells/mm3
- viral load less than 50 cp/mL and CD4 earning less than 100 cells/mm3 during last 24 months
Key exclusion criteria (5 listed)
- HIV-2 infection
- X4 tropism at inclusion
- pregnancy and breast feeding
- interferon, immunomodulatory drugs treatment or anti-HIV vaccines and chemotherapy
- hypersensibility of peanut or soya
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 150 mg or 300 mg or 600 mg twice a day for 24 weeks | Drug | – |
Primary outcome
Evaluation of maraviroc intensification during 24 weeks in HIV infected patients with insufficient immune restoration despite controlled viral load
Time frame: immunologic benefit at week 24
1 secondary outcome
Maraviroc efficacy at W24 (virological and immunological efficacy); Durability of maraviroc efficacy between W24 & W36; Cmin of maraviroc and other molecules at W4,12,24; Evaluation of the safety of maraviroc between W0 and W36.
Time frame: immuno-virologic evolution between week 0 and week 36
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 6 Apr 2026.
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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.
Lise CUZIN, MD principal investigator
CHU Purpan - Toulouse (France)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing maraviroc in people with HIV Infection and HIV Infections, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site 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 4 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 6 Apr 2026. 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 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?
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?
Evaluation of maraviroc intensification during 24 weeks in HIV infected patients with insufficient immune restoration despite controlled viral load (time frame: immunologic benefit at 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 6 Apr 2026.