HIV InfectionsPhase 3NCT00808002
Efficacy of Treatment Intensification With Maraviroc on HIV-1 Viral Latency in Recently Infected Hiv-1 naïve Patients Starting Raltegravir Plus Tenofovir/Emtricitabine
A Phase 3 study testing Raltegravir, Maraviroc and Tenofovir/Emtricitabine in people with HIV Infections, run by Germans Trias i Pujol Hospital at 2 sites in Spain.
Trial summary
The intensification with maraviroc in recently HIV-1-infected patients of a preferred gold-standard triple therapy composed of raltegravir plus tenofovir/emtricitabine could accelerate the decay of the HIV-1 reservoir in latently infected cells established early in HIV-1 infection. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Raltegravir, Maraviroc and Tenofovir/Emtricitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSpain
- Study dates
- Feb 2009to Nov 2011
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 infected adults (>=18 years old).
- No previous antiretroviral therapy for more than 2 weeks.
- HIV-1 infection documented in the past 6 months by a previous negative ELISA test, or a documented clinical acute seroconversion in the past 6 months.
- CCR5-tropism confirmed at screening.
- Voluntary written informed consent.
Who cannot join
- Pregnancy or fertile women willing to be pregnant.
- Active substance abuse or major psychiatric disease.
- Presence of NRTI mutations in the screening genotype.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Clinic i Provincial de Barcelona
Barcelona, 08916
About this study
Official title: Efficacy of Treatment Intensification With Maraviroc on HIV-1 Viral Latency in Recently Infected Hiv-1 naïve Patients Starting Raltegravir Plus Tenofovir/Emtricitabine.
The intensification with maraviroc in recently HIV-1-infected patients of a preferred gold-standard triple therapy composed of raltegravir plus tenofovir/emtricitabine could accelerate the decay of the HIV-1 reservoir in latently infected cells established early in HIV-1 infection.
This could provide further insight into this area, decrease the size of latent reservoir, and translate into clinical benefits for patients.
Read the detailed description
A reservoir of latently infected cells established early in infection may be involved in the maintenance of viral persistence despite continuous highly active antiretroviral therapy (HAART). This is likely to represent the major barrier to virus eradication in patients on successful combination antiretroviral therapy.
The majority of the viruses in the latent reservoir use CCR5 receptor during entry.
More recently, clear evidences for decay of this HIV-1 reservoir in patients who initiated antiretroviral therapy early in infection have been demonstrated. The treatment of acute infection may set the stage for subsequent attempts at eradication. To achieve this, more potent antiretroviral therapy and/or more potent antilatency therapies may be needed.
In contrast to previous antiretroviral drugs, maraviroc does not need to cross the cell membrane, nor does not require intracellular processing in order to exert its activity. In addition, there is no cross-resistance between entry inhibitors and agents that act on intracellular targets.
Maraviroc has demonstrated potent antiviral activity against all CCR5-tropic HIV-1 viruses tested. Maraviroc could thus fulfil the requirements for an optimal candidate for treatment intensification in HIV-1 infected patients with a recent HIV-1 infection.
- Conditions
- HIV Infections
- Being tested
- Raltegravir, Maraviroc, Tenofovir/Emtricitabine
- Keywords
- Maraviroc, CCR5 antagonists, Primary HIV Infection, HIV-1 reservoir, eradication, treatment naive
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaltegravirDrug
Raltegravir 400 mg every 12 hours
MaravirocDrug
Maraviroc 300 mg every 12 hours
Tenofovir/EmtricitabineDrug
Tenofovir/Emtricitabine 300/200 mg every 24 hours
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | From Baseline to Week48: Raltegravir BID + Tenofovir/Emtricitabine QD + Maraviroc BID From W48 to W72: Raltegravir BID + Tenofovir/Emtricitabine QD Receives: Drug: Raltegravir; Drug: Maraviroc; Drug: Tenofovir/Emtricitabine |
| 2 | Active comparator | Start ARV treatment with : Raltegravir BID + Tenofovir/Emtricitabine Receives: Drug: Raltegravir; Drug: Tenofovir/Emtricitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change at 48 weeks in the slope of decay of integrated and unintegrated viral DNA in PBMCs.
Measured: BL, W2, W4, W12, W24, W48
Secondary outcomes (10)
Decay of residual HIV-1 replication under maraviroc intensification assessed by an ultrasensitive RT-PCR assay with a lower limit of quantification of 5 copies/mL.
Measured: BL, W2, W4, W8, W12, W24, W36, W48
Blips during the study (viral load >50 copies/mL, preceded and followed by determinations <50 copies/mL in previous and posterior controls).
Measured: From Baseline to W48
HIV-1 RNA below 50 copies/mL at 48 weeks.
Measured: W48
Change in the lymphocyte activation marker HLADR+CD38+ from baseline to week 48.
Measured: BL, W4, W12, W24, W48, W60, W72
Relationship between maraviroc and/or raltegravir plasma concentrations and change in the slope of decay of integrated viral DNA in PBMCs
Measured: W12, W24, W48
HIV-1 specific CTL responses
Measured: BL, W24, W48, W60, W72
Plasmatic inflammation biomarkers
Measured: BL, W2, W4, W12, W48, W60
RNA, DNA and viral p24 associated to cells in ileum biopsy and PBMC
Measured: W48
Lymphocyte activation marker HLADR+CD38+ in ileum biopsy and PBMC
Measured: W48
Fibrosis markers in ileum biopsy and PBMC
Measured: W48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2008 (estimated)
- Study startFeb 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr . BONAVENTURA CLOTET, Germans Trias i Pujol Hospital
- Investigators
- Bonaventura Clotet, MD,PhD, Principal investigator, LLuita contra la SIDA Foundation-HIV UnitJosep Mª Llibre, MD,PhD, Principal investigator, LLuita contra la SIDA Foundation-HIV Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808002
- Sponsor's protocol ID
- MARAVIBOOST
- Status last verified
- Jan 2020
- First submitted
- 12 Dec 2008
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Treatment Intensification With Maraviroc on HIV-1 Viral Latency in Recently Infected Hiv-1 naïve Patients Starting Raltegravir Plus Tenofovir/Emtricitabine.
- ClinicalTrials.gov ID
- NCT00808002
- Acronym / sponsor ID
- MARAVIBOOST
- Conditions
- HIV Infections
- Keywords
- Maraviroc, CCR5 antagonists, Primary HIV Infection, HIV-1 reservoir, eradication, treatment naive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 15 Dec 2008 (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 intensification with maraviroc in recently HIV-1-infected patients of a preferred gold-standard triple therapy composed of raltegravir plus tenofovir/emtricitabine could accelerate the decay of the HIV-1 reservoir in latently infected cells established early in HIV-1 infection.
This could provide further insight into this area, decrease the size of latent reservoir, and translate into clinical benefits for patients.
Detailed description
A reservoir of latently infected cells established early in infection may be involved in the maintenance of viral persistence despite continuous highly active antiretroviral therapy (HAART). This is likely to represent the major barrier to virus eradication in patients on successful combination antiretroviral therapy.
The majority of the viruses in the latent reservoir use CCR5 receptor during entry.
More recently, clear evidences for decay of this HIV-1 reservoir in patients who initiated antiretroviral therapy early in infection have been demonstrated. The treatment of acute infection may set the stage for subsequent attempts at eradication. To achieve this, more potent antiretroviral therapy and/or more potent antilatency therapies may be needed.
In contrast to previous antiretroviral drugs, maraviroc does not need to cross the cell membrane, nor does not require intracellular processing in order to exert its activity. In addition, there is no cross-resistance between entry inhibitors and agents that act on intracellular targets.
Maraviroc has demonstrated potent antiviral activity against all CCR5-tropic HIV-1 viruses tested. Maraviroc could thus fulfil the requirements for an optimal candidate for treatment intensification in HIV-1 infected patients with a recent HIV-1 infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Raltegravir, Drug: Maraviroc, Drug: Tenofovir/EmtricitabineFrom Baseline to Week48: Raltegravir BID + Tenofovir/Emtricitabine QD + Maraviroc BID From W48 to W72: Raltegravir BID + Tenofovir/Emtricitabine QD |
| 2 | Active comparator | Drug: Raltegravir, Drug: Tenofovir/EmtricitabineStart ARV treatment with : Raltegravir BID + Tenofovir/Emtricitabine |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV-1 infected adults (>=18 years old).
- No previous antiretroviral therapy for more than 2 weeks.
- HIV-1 infection documented in the past 6 months by a previous negative ELISA test, or a documented clinical acute seroconversion in the past 6 months.
- CCR5-tropism confirmed at screening.
- Voluntary written informed consent.
Key exclusion criteria (3 listed)
- Pregnancy or fertile women willing to be pregnant.
- Active substance abuse or major psychiatric disease.
- Presence of NRTI mutations in the screening genotype.
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 |
|---|---|---|
| RaltegravirRaltegravir 400 mg every 12 hours | Drug | 1, 2 |
| MaravirocMaraviroc 300 mg every 12 hours | Drug | 1 |
| Tenofovir/EmtricitabineTenofovir/Emtricitabine 300/200 mg every 24 hours | Drug | 1, 2 |
Primary outcome
Change at 48 weeks in the slope of decay of integrated and unintegrated viral DNA in PBMCs.
Time frame: BL, W2, W4, W12, W24, W48
10 secondary outcomes
Decay of residual HIV-1 replication under maraviroc intensification assessed by an ultrasensitive RT-PCR assay with a lower limit of quantification of 5 copies/mL.
Time frame: BL, W2, W4, W8, W12, W24, W36, W48
Blips during the study (viral load >50 copies/mL, preceded and followed by determinations <50 copies/mL in previous and posterior controls).
Time frame: From Baseline to W48
HIV-1 RNA below 50 copies/mL at 48 weeks.
Time frame: W48
Change in the lymphocyte activation marker HLADR+CD38+ from baseline to week 48.
Time frame: BL, W4, W12, W24, W48, W60, W72
Relationship between maraviroc and/or raltegravir plasma concentrations and change in the slope of decay of integrated viral DNA in PBMCs
Time frame: W12, W24, W48
HIV-1 specific CTL responses
Time frame: BL, W24, W48, W60, W72
Plasmatic inflammation biomarkers
Time frame: BL, W2, W4, W12, W48, W60
RNA, DNA and viral p24 associated to cells in ileum biopsy and PBMC
Time frame: W48
Lymphocyte activation marker HLADR+CD38+ in ileum biopsy and PBMC
Time frame: W48
Fibrosis markers in ileum biopsy and PBMC
Time frame: W48
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 31 Jan 2020.
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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.
Bonaventura Clotet, MD,PhD principal investigator
LLuita contra la SIDA Foundation-HIV Unit
Josep Mª Llibre, MD,PhD principal investigator
LLuita contra la SIDA Foundation-HIV Unit
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Raltegravir, Maraviroc and Tenofovir/Emtricitabine in people with HIV Infections, run by Germans Trias i Pujol Hospital at 2 sites in Spain.
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 5 inclusion and 3 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 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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 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?
Change at 48 weeks in the slope of decay of integrated and unintegrated viral DNA in PBMCs. (time frame: BL, W2, W4, W12, W24, W48). 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 31 Jan 2020.