HIV InfectionsPhase 4NCT00884858
Maraviroc in Immunological Non-Responder (INR) HIV-1-infected Subjects
A Phase 4 study testing Maraviroc in people with HIV Infections, run by ASST Fatebenefratelli Sacco at 20 sites in Italy.
Trial summary
Suboptimal improvement in cluster of differentiation 4 (CD4) cell count is not uncommon in HIV-1-infected patients with suppressed plasma HIV-Ribonucleic acid (RNA) levels, and a decrease in CD4 cell count in patients with suppressed or low level viremia has been observed. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 20 sitesItaly
- Study dates
- Apr 2009to Apr 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > or = 18
- HIV-Abs positivity detected by ELISA and confirmed by Western-Blot
- CD4 lymphocytes < 200/uL and/or CD4 recovery < 25% after at least 12 months of stable HAART
- HIV-RNA < 50 cp/mL during the last 12 months
- negative pregnancy test at least 14 days prior to treatment
- understanding and signing the informed consent
Who cannot join
- allergy/intolerance to the study drug
- less than 1 year from any treatment with immunomodulatory agents
- current OIs or neoplasms
- current CVD or EKG abnormalities
- current respiratory tract diseases or COPD
- treatment with steroids within 4 weeks from treatment beginning
Show all 15Show fewer
- suspect of autoimmune disorder or chronic inflammatory disease
- active IVDUs or alcohol addicts
- AST and ALT > 2.5 ULD
- serum creatinine > 1.5 ULD
- ANC < 1000/uL
- hemoglobin < 10 g/dL
- platelets < 75.000/uL
- reticulocytes > 2%
- Karnofsky score < 50
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Italy20 sites
Divisione di Malattie Infettive, Ospedale S. Maria Annunziata
Antella, FI, 50011
Clinica di Malattie Infettive, Policlinico, Universita' degli Studi
Bari, BA, 70124
Clinica di Malattie Infettive e Tropicali, Università degli Studi di Brescia, Spedali civili
Brescia, BS, 25125
Clinica di Malattie Infettive, Ospedale San Martino
Genova, GE, 16132
Polo di Medicina Chirurgia e Odontoiatria, Polo Didattico S. Paolo
Milan, MI, 20124
U.O di Malattie Infettive, Fondazione San Raffaele del Monte Tabor
Milan, MI, 20132
Divisione Clinicizzata di Malatie Infettive, Azienda Ospedaliera-Polo Universitario "Luigi Sacco"
Milan, MI, 20157
I e II Divisione Malattie Infettive, Azienda Ospedaliera-Polo Universitario Luigi Sacco
Milan, MI, 20157
Clinica delle Malattie Infettive, Policlinico Universitario
Modena, MO, 41100
Divisione di Malattie Infettive, Ospedale San Gerardo
Monza, MB, 20052
Divisione Dipartimento Urgenze Infettivologiche ad Alta Complessità e correlate all'AIDS, Ospedale Cotugno
Naples, Napoli, 80131
Clinica delle Malattie Infettive, Policlinico Monteluce
Perugia, PG, 06126
U.O. Malattie Infettive, Ospedale S. Spirito
Pescara, PE, 65100
Clinica delle Malattie Infettive, Policlinico "Tor Vergata"
Roma, RM, 00133
III Divisione di Malattie Infettive, I.N.M.I Lazzaro Spallanzani
Roma, RM, 00149
IV Divisione di Malattie Infettive, INMI Lazzaro Spallanzani
Roma, RM, 00149
U.O. Malattie Infettive, Azienda Policlinico Umberto I
Roma, RM, 00161
Istituto Clinica delle Malattie Infettive, Università Cattolica del Sacro Cuore
Roma, RM, 00168
Clinica delle Malattie Infettive ,Ospedale Amedeo di Savoia
Torino, TO, 10149
Servizio Regionale di Immunologia Clinica e Tipizzazione Tissutale, Azienda Ospedaliero-Universitaria
Torrette Di Ancona, AN, 60126
About this study
Official title: Use of Maraviroc (MVC) in Immunological Non-responder HIV-1-infected Patients.
Suboptimal improvement in cluster of differentiation 4 (CD4) cell count is not uncommon in HIV-1-infected patients with suppressed plasma HIV-Ribonucleic acid (RNA) levels, and a decrease in CD4 cell count in patients with suppressed or low level viremia has been observed.
Although the efficacy of current antiretroviral medications is well established, some antiviral combinations are very effective in suppressing HIV-1 load whereas do not exert any effect on immune reconstitution.
Read more
Both T-cell immune activation and fibrosis of peripheral lymphoid tissue could create an environment in which CD4 T cell count decrease in the setting of low or suppressed plasma viremia is likely to occur.
Another fascinating hypothesis, which has still to be elucidated, is that reconstitution of the depleted CD4 pool is blocked by an excess of glycoprotein 120 (gp120) HIV-1 protein. This extra-production could be counteracted by an inhibitor of the chemokine (C-C motif) receptor 5 (CCR5) co-receptor that represents one of the major docking tools of HIV-1.
With this in mind, the investigators would like to propose and design a pilot exploratory clinical trial involving a population of HIV-1-infected patients that rapidly reached a virologic suppression without a reconstitution of their immune system.
Read the detailed description
Objectives:
- Evaluate the clinical efficacy of HAART intensification with MVC as treatment of HIV-1 infection in patients with a CD4 count ≤ 200 cells/uL and/or a recovery of CD4 cells < 25% compared to the HAART initiation and with a complete and stable virologic suppression after 12 months of HAART. Patients could also being included if their CD4 slope has been stable without any improvement, with an absolute value around 200 cells/uL.
- Evaluate the effects of HAART intensification with MVC on the modification of immunologic and virologic parameters.
- Evaluate the tolerability of HAART intensification with MVC and the appearance of drug-related side effects.
Design:
This will be a randomised, multicenter, study that will evaluate HAART intensification with MVC as treatment of HIV-1 infection in patients with a CD4 count ≤ 200 cells/uL and/or a recovery of CD4 cells < 25% compared to the HAART initiation and/or a stable CD4 slope without any improvement, with an absolute value around 200 cells/uL and with a complete and stable virologic suppression after 12 months of HAART.
- Conditions
- HIV Infections
- Being tested
- Maraviroc
- Keywords
- HIV-1, CD4, INR, HIV-1 infection, extreme immunological compromission, treatment experienced
- 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 Maraviroc brand name in the EC is Celsentri.
Maraviroc is administered BID according to the other drugs within HAART; dosage ranges from 150 mg to 600 mg bid.
| Study group | Role | What they receive |
|---|---|---|
| Maraviroc | Experimental | Subjects in this group will add Maraviroc to their current HAART. Receives: Drug: Maraviroc |
| 2 | No intervention | Subjects in this group will continue their current HAART without adding Maraviroc. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD4 counts > 200/uL or recovery of CD4 > 25% in 2 consecutive time-points.
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2011
- Study completionApr 2011
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASST Fatebenefratelli Sacco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Rusconi, ASST Fatebenefratelli Sacco
- Investigators
- Stefano Rusconi, M.D., Principal investigator, Universita' degli Studi di Milano, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884858
- Sponsor's protocol ID
- HLS/MVC01/2008
- Status last verified
- Apr 2013
- First submitted
- 20 Apr 2009
- Last updated
- 30 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Rusconi S, Vitiello P, Adorni F, Colella E, Foca E, Capetti A, Meraviglia P, Abeli C, Bonora S, D'Annunzio M, Di Biagio A, Di Pietro M, Butini L, Orofino G, Colafigli M, d'Ettorre G, Francisci D, Parruti G, Soria A, Buonomini AR, Tommasi C, Mosti S, Bai F, Di Nardo Stuppino S, Morosi M, Montano M, Tau P, Merlini E, Marchetti G. Maraviroc as intensification strategy in HIV-1 positive patients with deficient immunological response: an Italian randomized clinical trial. PLoS One. 2013 Nov 14;8(11):e80157. doi: 10.1371/journal.pone.0080157. eCollection 2013.
PubMed 24244635
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Maraviroc (MVC) in Immunological Non-responder HIV-1-infected Patients.
- ClinicalTrials.gov ID
- NCT00884858
- Acronym / sponsor ID
- HLS/MVC01/2008
- Conditions
- HIV Infections
- Keywords
- HIV-1, CD4, INR, HIV-1 infection, extreme immunological compromission, treatment experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- ASST Fatebenefratelli SaccoUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 21 Apr 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.
Suboptimal improvement in cluster of differentiation 4 (CD4) cell count is not uncommon in HIV-1-infected patients with suppressed plasma HIV-Ribonucleic acid (RNA) levels, and a decrease in CD4 cell count in patients with suppressed or low level viremia has been observed.
Although the efficacy of current antiretroviral medications is well established, some antiviral combinations are very effective in suppressing HIV-1 load whereas do not exert any effect on immune reconstitution.
Both T-cell immune activation and fibrosis of peripheral lymphoid tissue could create an environment in which CD4 T cell count decrease in the setting of low or suppressed plasma viremia is likely to occur.
Another fascinating hypothesis, which has still to be elucidated, is that reconstitution of the depleted CD4 pool is blocked by an excess of glycoprotein 120 (gp120) HIV-1 protein. This extra-production could be counteracted by an inhibitor of the chemokine (C-C motif) receptor 5 (CCR5) co-receptor that represents one of the major docking tools of HIV-1.
With this in mind, the investigators would like to propose and design a pilot exploratory clinical trial involving a population of HIV-1-infected patients that rapidly reached a virologic suppression without a reconstitution of their immune system.
Detailed description
Objectives:
- Evaluate the clinical efficacy of HAART intensification with MVC as treatment of HIV-1 infection in patients with a CD4 count ≤ 200 cells/uL and/or a recovery of CD4 cells < 25% compared to the HAART initiation and with a complete and stable virologic suppression after 12 months of HAART. Patients could also being included if their CD4 slope has been stable without any improvement, with an absolute value around 200 cells/uL.
- Evaluate the effects of HAART intensification with MVC on the modification of immunologic and virologic parameters.
- Evaluate the tolerability of HAART intensification with MVC and the appearance of drug-related side effects.
Design:
This will be a randomised, multicenter, study that will evaluate HAART intensification with MVC as treatment of HIV-1 infection in patients with a CD4 count ≤ 200 cells/uL and/or a recovery of CD4 cells < 25% compared to the HAART initiation and/or a stable CD4 slope without any improvement, with an absolute value around 200 cells/uL and with a complete and stable virologic suppression after 12 months of HAART.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maraviroc | Experimental | Drug: MaravirocSubjects in this group will add Maraviroc to their current HAART. |
| 2 | No intervention | –Subjects in this group will continue their current HAART without adding Maraviroc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age > or = 18
- HIV-Abs positivity detected by ELISA and confirmed by Western-Blot
- CD4 lymphocytes < 200/uL and/or CD4 recovery < 25% after at least 12 months of stable HAART
- HIV-RNA < 50 cp/mL during the last 12 months
- negative pregnancy test at least 14 days prior to treatment
Key exclusion criteria (15 listed)
- allergy/intolerance to the study drug
- less than 1 year from any treatment with immunomodulatory agents
- current OIs or neoplasms
- current CVD or EKG abnormalities
- current respiratory tract diseases or COPD
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: Maraviroc brand name in the EC is Celsentri.Maraviroc is administered BID according to the other drugs within HAART; dosage ranges from 150 mg to 600 mg bid. | Drug | Maraviroc |
Primary outcome
CD4 counts > 200/uL or recovery of CD4 > 25% in 2 consecutive time-points.
Time frame: 3 and 12 months
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 30 Apr 2013.
- Derived from this study: PubMed 24244635Rusconi S, Vitiello P, Adorni F, Colella E, Foca E, Capetti A, Meraviglia P, Abeli C, Bonora S, D'Annunzio M, Di Biagio A, Di Pietro M, Butini L, Orofino G, Colafigli M, d'Ettorre G, Francisci D, Parruti G, Soria A, Buonomini AR, Tommasi C, Mosti S, Bai F, Di Nardo Stuppino S, Morosi M, Montano M, Tau P, Merlini E, Marchetti G. Maraviroc as intensification strategy in HIV-1 positive patients with deficient immunological response: an Italian randomized clinical trial. PLoS One. 2013 Nov 14;8(11):e80157. doi: 10.1371/journal.pone.0080157. eCollection 2013.
Related trials for HIV Infections
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
Not yet recruitingPhase 4
NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
HIV Infections, Opioid Use Disorder
Enrolling by invitation
Effect of Omega-3 Supplementation on Pregnant Outcomes and Inflammation Markers of Women Infected With HIV Using Antiretroviral Therapy
Pregnant HIV Positive Women
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
HC-HMP: Healthy Choices Implementation Trial
Alcohol Drinking, HIV Infections
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.
Stefano Rusconi, M.D. principal investigator
Universita' degli Studi di Milano, Italy
20 sites 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 in people with HIV Infections, run by ASST Fatebenefratelli Sacco at 20 sites in Italy.
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 15 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 30 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Italy. 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?
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?
CD4 counts > 200/uL or recovery of CD4 > 25% in 2 consecutive time-points. (time frame: 3 and 12 months). 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 NCT00884858, 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 30 Apr 2013.