HIV InfectionPhase 4GUSTANCT01367210
Switch to Darunavir/r + Maraviroc Quaque Die in Patients With R5 Tropism by Viral DNA Genotyping (GUSTA)
A Phase 4 study testing Maraviroc, Darunavir/r and current antiretroviral therapy with 3 drugs in people with HIV Infection, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
Objectives of the study: 1. To verify the safety and the efficacy of the study treatment, defined as the persistent control of the virus' replication at 48 weeks after the simplification to maraviroc + darunavir with ritonavir in patients with R5 tropism by viral DNA genotyping. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- Maraviroc, Darunavir/r and current antiretroviral therapy with 3 drugs
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2011to Jun 2015
- 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
- Patients treated with the same regimen including 3 HAART from at least 4 months
- Aged 18 years or older
- Who gave informed consent to the participation to the study
- With at least two viral load < 50 copies/mL in two consecutive determinations at least 6 months apart (tolerance of two weeks)
- With CD4 cell count > 200 cells/μL and absence of any opportunistic infection or AIDS-related disease for at least one year prior to the screening.
- With R5 tropism by viral DNA genotyping (geno2pheno "clonal")
- With CD4 cell count nadir>50 cell/mmc or 100 cell/mmc if previous enfuvirtide or integrase inhibitors use
Who cannot join
- With at least one major or two minor mutation conferring resistance to darunavir reported in the update list of International AIDS Society - USA , in previous resistance test
- Previous D/M or X4 viral tropism
- Previous major clinical toxicities (grade >=3) to the proposed drugs of the study
- Pregnancy or breast feeding, desire of pregnancy in the short term
- Past exposure to Chemokine Receptor 5 antagonist
- HBsAg serostatus
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- Liver cirrhosis of class C (Child-Pugh)
- Sulpha drug hypersensitivity
- The presence of major non AIDS-defining diseases that, in the opinion of the investigator, may compromise the retention of the patient in the study for the necessary follow-up period.
- Estimated glomerular filtration < 30 ml/min (cockroft-Gaut; MDRD formula if black-African or african-american) at screening visit
- Hypertransaminasemia of grade IV (more than 10 times the upper normal limit) at screening visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Switch to Darunavir/r + Maraviroc QD in Patients With R5 Tropism by Viral DNA Genotyping With Suppressed Viremia (GUSTA): a Multicenter, Open-label, Randomized Controlled Trial
Objectives of the study:
- To verify the safety and the efficacy of the study treatment, defined as the persistent control of the virus' replication at 48 weeks after the simplification to maraviroc + darunavir with ritonavir in patients with R5 tropism by viral DNA genotyping.
- To collect relevant information about the safety, the immunologic and the economic impact of this strategy.
- Conditions
- HIV Infection
- Being tested
- Maraviroc, Darunavir/r, current antiretroviral therapy with 3 drugs
- Keywords
- HIV, AIDS, Highly Active AntiRetroviral Therapy, Simplification, Maraviroc, Darunavir, Treatment experienced, Tropism
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maraviroc, Darunavir/rDrug
Maraviroc 300 mg Darunavir 800 mg Ritonavir 100 mg
current antiretroviral therapy with 3 drugsDrug
To continue the assumption of previous HAART
| Study group | Role | What they receive |
|---|---|---|
| MARAVIROC, DARUNAVIR/r | Experimental | Treatment simplification from a "standard" combined antiretroviral therapy including 3 drugs to Maraviroc plus Darunavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy Receives: Drug: Maraviroc, Darunavir/r |
| current ART with 3 drugs | Sham comparator | Patients on HAART with three drugs and HIV RNA below 50 copies/mL Receives: Drug: current antiretroviral therapy with 3 drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients with virological failure (two consecutive measures of HIV-RNA higher than 50 copies/mL or a single measure higher than 1000 copies/mL) within 48 weeks at per protocol analysis, with switch=failure
Measured: 48 weeks
Secondary outcomes (11)
proportion of patients with virological failure (two consecutive measures of HIV-RNA higher than 50 copies/mL or a single measure higher than 1000 copies/mL) within 96 weeks at intention-to treat analysis with missing value=Failure
Measured: 96 weeks
Time to virological failure at survival analysis
Measured: 48 weeks
Proportion of patients with at failure X4 tropism viral tropism (RNA or DNA genotyping)
Measured: 48 weeks
Evolution of CD4 cell- cluster of differentiation 4 cell count during the 96 weeks
Measured: 96 weeks
Evolution of adherence and quality of life after 24, 48 and 96 weeks
Measured: 96 weeks
Evolution of maraviroc, darunavir, ritonavir plasma concentrations during the 96 weeks
Measured: 96 weeks
Evolution of metabolic parameters at 96 weeks
Measured: 96 weeks
Change of the results of neurocognitive tests at 48 and 96 weeks
Measured: 96 weeks
Modification of bone density and subcutaneous fat at 48 and 96 weeks
Measured: 96 weeks
Modification of Intima-Media Thickness and Flow Mediated Dilation at 48 and 96 weeks
Measured: 96 weeks
Economic impact of Darunavir/ritonavir+ Maraviroc versus Highly Active Antiretroviral Therapy
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: Because a higher rate of virological failures in study versus control arm.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simona Di Giambenedetto, Catholic University of the Sacred Heart
- Investigators
- Andrea De Luca, Prof, Principal investigator, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01367210
- Sponsor's protocol ID
- 2010-023316-13
- Acronym
- GUSTA
- Status last verified
- Feb 2016
- First submitted
- 3 Jun 2011
- Last updated
- 8 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switch to Darunavir/r + Maraviroc QD in Patients With R5 Tropism by Viral DNA Genotyping With Suppressed Viremia (GUSTA): a Multicenter, Open-label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01367210
- Acronym / sponsor ID
- GUSTA / 2010-023316-13
- Conditions
- HIV Infection
- Keywords
- HIV, AIDS, Highly Active AntiRetroviral Therapy, Simplification, Maraviroc, Darunavir, Treatment experienced, Tropism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because a higher rate of virological failures in study versus control arm.
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 7 Jun 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.
Objectives of the study:
- To verify the safety and the efficacy of the study treatment, defined as the persistent control of the virus' replication at 48 weeks after the simplification to maraviroc + darunavir with ritonavir in patients with R5 tropism by viral DNA genotyping.
- To collect relevant information about the safety, the immunologic and the economic impact of this strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MARAVIROC, DARUNAVIR/r | Experimental | Drug: Maraviroc, Darunavir/rTreatment simplification from a "standard" combined antiretroviral therapy including 3 drugs to Maraviroc plus Darunavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy |
| current ART with 3 drugs | Sham comparator | Drug: current antiretroviral therapy with 3 drugsPatients on HAART with three drugs and HIV RNA below 50 copies/mL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients treated with the same regimen including 3 HAART from at least 4 months
- Aged 18 years or older
- Who gave informed consent to the participation to the study
- With at least two viral load < 50 copies/mL in two consecutive determinations at least 6 months apart (tolerance of two weeks)
- With CD4 cell count > 200 cells/μL and absence of any opportunistic infection or AIDS-related disease for at least one year prior to the screening.
Key exclusion criteria (11 listed)
- With at least one major or two minor mutation conferring resistance to darunavir reported in the update list of International AIDS Society - USA , in previous resistance test
- Previous D/M or X4 viral tropism
- Previous major clinical toxicities (grade >=3) to the proposed drugs of the study
- Pregnancy or breast feeding, desire of pregnancy in the short term
- Past exposure to Chemokine Receptor 5 antagonist
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, Darunavir/rMaraviroc 300 mg Darunavir 800 mg Ritonavir 100 mg | Drug | MARAVIROC, DARUNAVIR/r |
| current antiretroviral therapy with 3 drugsTo continue the assumption of previous HAART | Drug | current ART with 3 drugs |
Primary outcome
proportion of patients with virological failure (two consecutive measures of HIV-RNA higher than 50 copies/mL or a single measure higher than 1000 copies/mL) within 48 weeks at per protocol analysis, with switch=failure
Time frame: 48 weeks
11 secondary outcomes
proportion of patients with virological failure (two consecutive measures of HIV-RNA higher than 50 copies/mL or a single measure higher than 1000 copies/mL) within 96 weeks at intention-to treat analysis with missing value=Failure
Time frame: 96 weeks
Time to virological failure at survival analysis
Time frame: 48 weeks
Proportion of patients with at failure X4 tropism viral tropism (RNA or DNA genotyping)
Time frame: 48 weeks
Evolution of CD4 cell- cluster of differentiation 4 cell count during the 96 weeks
Time frame: 96 weeks
Evolution of adherence and quality of life after 24, 48 and 96 weeks
Time frame: 96 weeks
Evolution of maraviroc, darunavir, ritonavir plasma concentrations during the 96 weeks
Time frame: 96 weeks
Evolution of metabolic parameters at 96 weeks
Time frame: 96 weeks
Change of the results of neurocognitive tests at 48 and 96 weeks
Time frame: 96 weeks
Modification of bone density and subcutaneous fat at 48 and 96 weeks
Time frame: 96 weeks
Modification of Intima-Media Thickness and Flow Mediated Dilation at 48 and 96 weeks
Time frame: 96 weeks
Economic impact of Darunavir/ritonavir+ Maraviroc versus Highly Active Antiretroviral Therapy
Time frame: 96 weeks
Results and safety
The study was stopped early (reason given: Because a higher rate of virological failures in study versus control arm.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
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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.
Andrea De Luca, Prof principal investigator
Catholic University of the Sacred Heart
1 site 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, Darunavir/r and current antiretroviral therapy with 3 drugs in people with HIV Infection, run by Catholic University of the Sacred Heart at 1 site 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 7 inclusion and 11 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: stopped early, as of the sponsor's last update on 8 Feb 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 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. 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 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 was stopped early (reason given: Because a higher rate of virological failures in study versus control arm.). 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?
proportion of patients with virological failure (two consecutive measures of HIV-RNA higher than 50 copies/mL or a single measure higher than 1000 copies/mL) within 48 weeks at per protocol analysis, with switch=failure (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 8 Feb 2016.