HIV-1 InfectionPhase 3OPTIMALNCT01348308
Immuno-stimulation With Maraviroc Combined to Antiretroviral Therapy in Advanced Late Diagnosed HIV-1 Infected Patients
A Phase 3 study testing Maraviroc (Celsentri) in people with HIV-1 Infection and AIDS, run by ANRS, Emerging Infectious Diseases at 1 site in France.
Trial summary
The objective of the OPTIMAL study is to demonstrate that the adjunction of Maraviroc to a combination of antiretroviral therapy in naive and late diagnosed HIV-1 infected patients counts may accelerate the kinetics of immune restoration and decrease the risk of disease progression and death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1 Infection, AIDS
- What is being tested?
- Maraviroc (Celsentri)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 407 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2011to Mar 2016
- Phase
- Phase 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
- Confirmed HIV-1 infection (ELISA and Western Blot tests positive)
- CD4+ T lymphocytes below or equal 200/mm³ or previous AIDS-defining-illness at diagnosis
- Patient naïve from any antiretroviral
- In women, use of a contraceptive method, and lack of actual pregnancy
- Patients with a coverage from social health
- After informed consent
Who cannot join
- Current pregnancy, lack of contraceptive method, breast-feeding
- Current active tuberculosis (either suspected, diagnosed)
- Ongoing malignancies except cutaneous Kaposi's sarcoma. Patients with a previous cancer considered as cured for at least 6 months could be included in the study
- Current or previous severe cardiac failure, chronic respiratory disease, renal or liver insufficiency; any life-threatening organ failure
- Cognitive impairment, psychiatric disorders, severe depressive affects, unadapted behavior
- Use of cytostatic drugs, immunosuppressive agents, steroids
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- PMN (polymorphonuclear neutrophil) below 750/mm³, platelets below 50,000/mm³, haemoglobin below 10 g/dL; ASAT (aspartate aminotransferase), ALAT (alanine aminotransferase) or bilirubin over 2.5 ULN; lipase over 2 ULN (Upper limit of normal), serum creatinine over 1.5 ULN; proteinuria over 1g/L; INR (International Normalized Ratio) abnormal
- Current or previous, during the 3 last months, use of immunomodulatory agents (G-CSF (granulocyte colony stimulating factor), IL-2 (Interleukin-2), GM-CSF (Granulocyte Macrophage colony stimulating factor), interferons, pentoxifylline)
- Hypersensitivity to peanut and /or soy products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimized Phase III Trial of Immuno-stimulation With Maraviroc, a CCR5 (Chemokine Receptor 5) Antagonist, Combined With Anti Retroviral Therapy in Advanced, Late Diagnosed HIV-1 Infected Patients With an AIDS-defining Event and/or CD4 (Cluster of Differentiation 4) Counts Below 200 Cells/mm³. ANRS 146 OPTIMAL
The objective of the OPTIMAL study is to demonstrate that the adjunction of Maraviroc to a combination of antiretroviral therapy in naive and late diagnosed HIV-1 infected patients counts may accelerate the kinetics of immune restoration and decrease the risk of disease progression and death.
It is a randomized, versus placebo, double-blind trial, conducted in France, Spain and Italy.
- Conditions
- HIV-1 Infection, AIDS
- Being tested
- Maraviroc (Celsentri), Placebo
- Keywords
- Late diagnosed HIV-1 infected patients, AIDS-defining events, Immune restoration
- 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.
Maraviroc (Celsentri)Drug
Patients will take cART optimized regimen according to the recommended regimen as first line of treatment in most commonly used guidelines with Maraviroc at the following dose: 150 mg orally twice a day for patients receiving a Protease Inhibitor Ritonavir-boosted regimen (except Fosamprenavir), 300 mg orally twice a day for patients receiving a Fosamprenavir Ritonavir-boosted regimen or 600 mg orally twice a day for patients receiving Efavirenz-based regimen.
Duration: 72 weeks.
PlaceboDrug
Patients will take cART optimized regimen according to the recommended regimen as first line of treatment in most commonly used guidelines with Placebo at the following dose: 150 mg orally twice a day for patients receiving a Protease Inhibitor Ritonavir-boosted regimen (except Fosamprenavir), 300 mg orally twice a day for patients receiving a Fosamprenavir Ritonavir-boosted regimen or 600 mg orally twice a day for patients receiving Efavirenz-based regimen.
Duration: 72 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Maraviroc | Active comparator | Maraviroc 300, 600 or 1200mg per day Receives: Drug: Maraviroc (Celsentri) |
| Placebo | Placebo comparator | Placebo 300, 600 or 1200mg per day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the clinical benefit of the adjunction of Maraviroc to a combination of antiretroviral therapy defined as decrease of clinical events
The clinical benefit is the reduction of occurence of a composite outcome consisting of:
- New AID-defining event (1993 CDC(Centers for Disease Control) expanded surveillance definition)
- Non B or C events (Aspergillosis, Bartonellosis, Chagas disease, Leishmaniasis, Lymphoma, Microsporidiosis chronic intestinal, Nocardiosis, Penicillium marneffei extrapulmonary, Pneumocystis jiroveci extrapulmonary, Rhodococcus equi disease, Severe bacterial infections)
- Serious non-AIDS events (Cardiovascular disease, Chronic end stage renal disease, Liver failure, Non-AIDS defining cancers, IRIS)
- All cause of mortality
Measured: From Week 0 to Week 72
Secondary outcomes (1)
Safety evaluation and Clinical, Immunological and pharmacological evaluation
The secondary end points:
- Clinical events (to compare Maraviroc and placebo arm for each component of the primary composite endpoint and other major outcomes)
- Immunological evaluation (T cells phenotypic analysis; seric markers of immune activation)
- Virological evaluation (plasma HIV viral load analysis; viral tropism testing,)
- Pharmacokinetic evaluation (plasma concentration of Maraviroc and relationship with virological response)
- Clinical and biological safety of the strategy (Adverse events >= grade 2 on ANRS scale of adverse event)
- Cost-effectiveness analysis
Measured: From Week 0 to Week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2016
- Study completionMar 2016
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.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Yves Levy, MD, PhD, Study chair, APHP, Hopital Henri Mondor, Creteil, FranceJean-Daniel Lelievre, MD, PhD, Principal investigator, APHP, Hopital Henri Mondor, Creteil, FranceDominique Costagliola, PhD, Study director, INSERM U943 and Univerité Pierre et Marie Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348308
- Sponsor's protocol ID
- 2010-022293-14
- Other IDs
- ANRS 146 OPTIMAL
- Acronym
- OPTIMAL
- Status last verified
- Jul 2016
- First submitted
- 2 May 2011
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Levy Y, Lelievre JD, Assoumou L, Aznar E, Pulido F, Tambussi G, Crespo M, Meybeck A, Molina JM, Delaugerre C, Izopet J, Peytavin G, Cardon F, Diallo A, Lancar R, Beniguel L, Costagliola D. Addition of Maraviroc Versus Placebo to Standard Antiretroviral Therapy for Initial Treatment of Advanced HIV Infection: A Randomized Trial. Ann Intern Med. 2020 Mar 3;172(5):297-305. doi: 10.7326/M19-2133. Epub 2020 Feb 11.
PubMed 32040959
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Phase III Trial of Immuno-stimulation With Maraviroc, a CCR5 (Chemokine Receptor 5) Antagonist, Combined With Anti Retroviral Therapy in Advanced, Late Diagnosed HIV-1 Infected Patients With an AIDS-defining Event and/or CD4 (Cluster of Differentiation 4) Counts Below 200 Cells/mm³. ANRS 146 OPTIMAL
- ClinicalTrials.gov ID
- NCT01348308
- Acronym / sponsor ID
- OPTIMAL / 2010-022293-14
- Conditions
- HIV-1 Infection, AIDS
- Keywords
- Late diagnosed HIV-1 infected patients, AIDS-defining events, Immune restoration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Pfizer
- Study start
- Sep 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 5 May 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 objective of the OPTIMAL study is to demonstrate that the adjunction of Maraviroc to a combination of antiretroviral therapy in naive and late diagnosed HIV-1 infected patients counts may accelerate the kinetics of immune restoration and decrease the risk of disease progression and death.
It is a randomized, versus placebo, double-blind trial, conducted in France, Spain and Italy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maraviroc | Active comparator | Drug: Maraviroc (Celsentri)Maraviroc 300, 600 or 1200mg per day |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 300, 600 or 1200mg per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed HIV-1 infection (ELISA and Western Blot tests positive)
- CD4+ T lymphocytes below or equal 200/mm³ or previous AIDS-defining-illness at diagnosis
- Patient naïve from any antiretroviral
- In women, use of a contraceptive method, and lack of actual pregnancy
- Patients with a coverage from social health
Key exclusion criteria (9 listed)
- Current pregnancy, lack of contraceptive method, breast-feeding
- Current active tuberculosis (either suspected, diagnosed)
- Ongoing malignancies except cutaneous Kaposi's sarcoma. Patients with a previous cancer considered as cured for at least 6 months could be included in the study
- Current or previous severe cardiac failure, chronic respiratory disease, renal or liver insufficiency; any life-threatening organ failure
- Cognitive impairment, psychiatric disorders, severe depressive affects, unadapted behavior
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 (Celsentri)Patients will take cART optimized regimen according to the recommended regimen as first line of treatment in most commonly used guidelines with Maraviroc at the following dose: 150 mg orally twice a day for patients receiving a Protease Inhibitor Ritonavir-boosted regimen (except Fosamprenavir), 300 mg orally twice a day for patients receiving a Fosamprenavir Ritonavir-boosted regimen or 600 mg orally twice a day for patients receiving Efavirenz-based regimen. Duration: 72 weeks. | Drug | Maraviroc |
| PlaceboPatients will take cART optimized regimen according to the recommended regimen as first line of treatment in most commonly used guidelines with Placebo at the following dose: 150 mg orally twice a day for patients receiving a Protease Inhibitor Ritonavir-boosted regimen (except Fosamprenavir), 300 mg orally twice a day for patients receiving a Fosamprenavir Ritonavir-boosted regimen or 600 mg orally twice a day for patients receiving Efavirenz-based regimen. Duration: 72 weeks. | Drug | Placebo |
Primary outcome
To demonstrate the clinical benefit of the adjunction of Maraviroc to a combination of antiretroviral therapy defined as decrease of clinical events
Time frame: From Week 0 to Week 72
The clinical benefit is the reduction of occurence of a composite outcome consisting of: * New AID-defining event (1993 CDC(Centers for Disease Control) expanded surveillance definition) * Non B or C events (Aspergillosis, Bartonellosis, Chagas disease, Leishmaniasis, Lymphoma, Microsporidiosis chronic intestinal, Nocardiosis, Penicillium marneffei extrapulmonary, Pneumocystis jiroveci extrapulmonary, Rhodococcus equi disease, Severe bacterial infections) * Serious non-AIDS events (Cardiovascular disease, Chronic end stage renal disease, Liver failure, Non-AIDS defining cancers, IRIS) * All cause of mortality
1 secondary outcome
Safety evaluation and Clinical, Immunological and pharmacological evaluation
Time frame: From Week 0 to Week 72
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 12 Jul 2016.
- Derived from this study: PubMed 32040959Levy Y, Lelievre JD, Assoumou L, Aznar E, Pulido F, Tambussi G, Crespo M, Meybeck A, Molina JM, Delaugerre C, Izopet J, Peytavin G, Cardon F, Diallo A, Lancar R, Beniguel L, Costagliola D. Addition of Maraviroc Versus Placebo to Standard Antiretroviral Therapy for Initial Treatment of Advanced HIV Infection: A Randomized Trial. Ann Intern Med. 2020 Mar 3;172(5):297-305. doi: 10.7326/M19-2133. Epub 2020 Feb 11.
- Related InfoLink provided by the sponsor.
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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.
Yves Levy, MD, PhD study chair
APHP, Hopital Henri Mondor, Creteil, France
Jean-Daniel Lelievre, MD, PhD principal investigator
APHP, Hopital Henri Mondor, Creteil, France
Dominique Costagliola, PhD study director
INSERM U943 and Univerité Pierre et Marie Curie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Maraviroc (Celsentri) in people with HIV-1 Infection and AIDS, run by ANRS, Emerging Infectious Diseases 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 6 inclusion and 9 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 12 Jul 2016. 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. Some participants in this study may receive a placebo. 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 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 demonstrate the clinical benefit of the adjunction of Maraviroc to a combination of antiretroviral therapy defined as decrease of clinical events (time frame: From Week 0 to Week 72). 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 NCT01348308, 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 12 Jul 2016.