HIVPhase 3NCT01896921
Switch to Maraviroc + Integrase Inhibitor
A Phase 3 study testing Switch to Maraviroc + Raltegravir or Dolutegravir in people with HIV, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
This clinical study proposes to evaluate the combination of maraviroc with an integrase strand transfer inhibitor (either raltegravir or dolutegravir) in antiretroviral-experienced patients to document the efficacy, safety, and tolerability of this combination in order to provide clinicians with a treatment regimen… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HIV
- What is being tested?
- Switch to Maraviroc + Raltegravir or Dolutegravir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Dec 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 infection
- Age between 18 and 75 years
- CD4 count nadir ≥ 250 cells/mm3
- HIV RNA ≤ 50 copies/ml for ≥ 12 months while taking any ART regimen
- o One virologic blip ≤ 400 copies/ml permissible within the 12 months
- CCR5 tropic virus as defined by:
Show all 9Show fewer
- trofile/tropism testing if available, OR
- DNA trofile if no trofile/tropism test available and CD4 nadir 250-499 cells/mm3, OR
- CD4 nadir ≥ 500 cells/mm3
Who cannot join
- Age < 18 or > 75 years
- CD4 count nadir < 250 cells/mm3
- Dual/mixed or X4 tropic virus if tested prior to viral suppression or if performed by DNA trofile testing at any time
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times the upper limits of normal
- Women who:
- are currently pregnant or breastfeeding
Show all 17Show fewer
- are of child-bearing age and do not agree to remain abstinent or use (or have their partner use) an acceptable method of birth control throughout the study. Acceptable method of birth control is defined as intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy.
- History of any malignancy except non-melanoma skin cancer
- Concomitant use of drugs known to impact or be impacted in terms of pharmacokinetics or drug-drug interactions with either raltegravir or maraviroc. This includes:
- Inducers of UGT1A1 (such as rifampin, phenytoin, phenobarbital rifabutin, St. John's wort)
- CYP3A inhibitors (such as ketoconazole, itraconazole, clarithromycin, nefazodone, and telithromycin)
- CYP3A inducers (such as rifampin, carbamazepine, phenobarbital and phenytoin)
- Subject requires or is anticipated to require any of the prohibited medications noted in the protocol
- Enrollment in an experimental protocol having received investigational agents (antiretroviral or non-antiretroviral) within 30 days of study enrollment
- Chronic active hepatitis B infection as defined by presence of HBsAg
- Subject has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might interfere with the patient's participation for the full duration of the study, such that it is not in the best interest of the patient to participate.
- Subject is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Institute of Human Virology
Baltimore, Maryland, 21201
About this study
Official title: Switch to Maraviroc and Integrase Strand Transfer Inhibitor Combination Therapy (a Triple Class-Sparing Regimen) for the Treatment of HIV-1-Infected Patients on Suppressive Antiretroviral Regimens
This clinical study proposes to evaluate the combination of maraviroc with an integrase strand transfer inhibitor (either raltegravir or dolutegravir) in antiretroviral-experienced patients to document the efficacy, safety, and tolerability of this combination in order to provide clinicians with a treatment regimen that minimizes the risk of metabolic complications by avoidance of NRTI/NNRTIs and PIs. The development of an alternative ART regimen which lessens the risk of metabolic complications could improve long-term adherence and reduce the risk of certain co-morbidities associated with long-term ART use. If this new combination is found to be as efficacious as the standard regimen with enhanced tolerability and improved metabolic effects, there is great potential for altering the current practice of HIV medicine.
Read the detailed description
Description of the study design:
The study will enroll 30 HIV-infected patients on a stable ART regimen with a suppressed HIV RNA < 50 copies/ml for at least one year. Patients will be switched to the experimental regimen (maraviroc 300 mg twice a day plus either raltegravir 400 mg twice a day or dolutegravir 50 mg once a-day) and followed for 96 weeks. The decision to use raltegravir or dolutegravir will be left to investigator/subject preference, as the two integrate inhibitors are largely interchangeable aside from twice daily (raltegravir) vs. daily (dolutegravir) dosing.
Primary endpoint:
- The primary endpoint is the proportion of patients virologically suppressed (HIV RNA < 50 copies/ml) at 48 weeks.
Definitions:
- Virologic suppression is an HIV RNA < 50 copies/ml.
- Virologic failure is an HIV RNA ≥ 50 copies/ml confirmed on 2 separate occasions, separated by > 1 week after viral suppression.
Secondary endpoints:
- The percent change in total cholesterol, LDL, and HDL at 48 and 96 weeks.
- The number of adverse events.
- The proportion of patients who are virologically suppressed (HIV RNA < 50 copies/ml) at 96 weeks.
Exploratory endpoints:
- Telomerase activity and telomere length measured at baseline and 24, 48, and 96 weeks.
- Conditions
- HIV
- Being tested
- Switch to Maraviroc + Raltegravir or Dolutegravir
- Keywords
- HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Switch to Maraviroc + Raltegravir or DolutegravirDrug
Change HIV-infected patients on stable, suppressed ART regimens for at least 1 year to experimental regimen of Maraviroc + Raltegravir or Dolutegravir for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Maraviroc + Raltegravir or Dolutegravir | Experimental | Maraviroc 300 mg tablet twice a day plus Raltegravir 400 mg tablet twice a day or Dolutegravir 50 mg tablet once a day for 48 weeks Receives: Drug: Switch to Maraviroc + Raltegravir or Dolutegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Virologically Suppressed (HIV RNA <50 Copies/ml) at 48 Weeks.
Number of patients virologically suppressed (HIV RNA <50 copies/ml) at 48 weeks.
Measured: 48 weeks
Secondary outcomes (2)
Number of Participants With Adverse Events
Number of participants with adverse events
Measured: 96 weeks
Number of Patients Who Are Virologically Suppressed (HIV RNA < 50 Copies/ml)
Number of patients who are virologically suppressed (HIV RNA < 50 copies/ml)
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 posted11 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Riedel, University of Maryland, Baltimore
- Investigators
- David J Riedel, MD, Principal investigator, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896921
- Sponsor's protocol ID
- HP-00056162
- Status last verified
- Oct 2021
- First submitted
- 27 Jun 2013
- Last updated
- 20 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switch to Maraviroc and Integrase Strand Transfer Inhibitor Combination Therapy (a Triple Class-Sparing Regimen) for the Treatment of HIV-1-Infected Patients on Suppressive Antiretroviral Regimens
- ClinicalTrials.gov ID
- NCT01896921
- Acronym / sponsor ID
- HP-00056162
- Conditions
- HIV
- Keywords
- HIV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 11 Jul 2013 (estimated)
- Results
- Posted 19 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study proposes to evaluate the combination of maraviroc with an integrase strand transfer inhibitor (either raltegravir or dolutegravir) in antiretroviral-experienced patients to document the efficacy, safety, and tolerability of this combination in order to provide clinicians with a treatment regimen that minimizes the risk of metabolic complications by avoidance of NRTI/NNRTIs and PIs. The development of an alternative ART regimen which lessens the risk of metabolic complications could improve long-term adherence and reduce the risk of certain co-morbidities associated with long-term ART use. If this new combination is found to be as efficacious as the standard regimen with enhanced tolerability and improved metabolic effects, there is great potential for altering the current practice of HIV medicine.
Detailed description
Description of the study design:
The study will enroll 30 HIV-infected patients on a stable ART regimen with a suppressed HIV RNA < 50 copies/ml for at least one year. Patients will be switched to the experimental regimen (maraviroc 300 mg twice a day plus either raltegravir 400 mg twice a day or dolutegravir 50 mg once a-day) and followed for 96 weeks. The decision to use raltegravir or dolutegravir will be left to investigator/subject preference, as the two integrate inhibitors are largely interchangeable aside from twice daily (raltegravir) vs. daily (dolutegravir) dosing.
Primary endpoint:
- The primary endpoint is the proportion of patients virologically suppressed (HIV RNA < 50 copies/ml) at 48 weeks.
Definitions:
- Virologic suppression is an HIV RNA < 50 copies/ml.
- Virologic failure is an HIV RNA ≥ 50 copies/ml confirmed on 2 separate occasions, separated by > 1 week after viral suppression.
Secondary endpoints:
- The percent change in total cholesterol, LDL, and HDL at 48 and 96 weeks.
- The number of adverse events.
- The proportion of patients who are virologically suppressed (HIV RNA < 50 copies/ml) at 96 weeks.
Exploratory endpoints:
- Telomerase activity and telomere length measured at baseline and 24, 48, and 96 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maraviroc + Raltegravir or Dolutegravir | Experimental | Drug: Switch to Maraviroc + Raltegravir or DolutegravirMaraviroc 300 mg tablet twice a day plus Raltegravir 400 mg tablet twice a day or Dolutegravir 50 mg tablet once a day for 48 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- HIV-1 infection
- Age between 18 and 75 years
- CD4 count nadir ≥ 250 cells/mm3
- HIV RNA ≤ 50 copies/ml for ≥ 12 months while taking any ART regimen
- o One virologic blip ≤ 400 copies/ml permissible within the 12 months
Key exclusion criteria (17 listed)
- Age < 18 or > 75 years
- CD4 count nadir < 250 cells/mm3
- Dual/mixed or X4 tropic virus if tested prior to viral suppression or if performed by DNA trofile testing at any time
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times the upper limits of normal
- Women who:
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 |
|---|---|---|
| Switch to Maraviroc + Raltegravir or DolutegravirChange HIV-infected patients on stable, suppressed ART regimens for at least 1 year to experimental regimen of Maraviroc + Raltegravir or Dolutegravir for 48 weeks | Drug | Maraviroc + Raltegravir or Dolutegravir |
Primary outcome
Number of Patients Virologically Suppressed (HIV RNA <50 Copies/ml) at 48 Weeks.
Time frame: 48 weeks
Number of patients virologically suppressed (HIV RNA <50 copies/ml) at 48 weeks.
2 secondary outcomes
Number of Participants With Adverse Events
Time frame: 96 weeks
Number of Patients Who Are Virologically Suppressed (HIV RNA < 50 Copies/ml)
Time frame: 96 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David J Riedel, MD principal investigator
University of Maryland, College Park
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 Switch to Maraviroc + Raltegravir or Dolutegravir in people with HIV, run by University of Maryland, Baltimore at 1 site in United States.
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 9 inclusion and 17 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 20 Oct 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 19 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients Virologically Suppressed (HIV RNA <50 Copies/ml) at 48 Weeks. (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 20 Oct 2021; AzTrials last refreshed its copy on 31 Oct 2026.