Acute HIV InfectionPhase 2/3NCT01154673
Effects of Intensive cART During Acute/Early HIV Infection
A Phase 2/3 study testing raltegravir, maraviroc and emtricitabine 200mg /tenofovir 300mg in people with Acute HIV Infection, run by University of Toronto at 2 sites in Canada.
Trial summary
This trial will investigate the efficacy and safety of intensified antiretroviral treatment that includes raltegravir and maraviroc during the early stages of HIV infection. With the proven efficacy of these antiviral drugs in pre- and post-clinical trials, we would like to investigate the ability of the combination… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute HIV Infection
- What is being tested?
- raltegravir, maraviroc and emtricitabine 200mg /tenofovir 300mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2011to Sep 2014
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The major single criterion for inclusion into the study will be the presence of confirmed acute/early HIV-1 infection, as defined by one of the three following criteria:
- Positive HIV-1 antibody test result (Western blot), with a documented negative test result in the previous six months or
- Positive or weakly positive HIV-1 antibody screening ELISA test result, with indeterminate and evolving confirmatory test result with demonstrated HIV-1 antigenemia (p24 antigen test result) or viremia (HIV-1 bDNA ≥ 500 copies/ml) or
- Negative HIV-1 antibody test result in the setting of an illness compatible with acute seroconversion with demonstrated HIV-1 antigenemia (p24 antigen test result) or plasma viremia (HIV-1 bDNA ≥ 500 copies/ml)
- Other inclusion criteria are:
- Ages 18 or older
- Ability to provide informed consent
- HIV-1 viral load ≥ 5,000 copies/ml
Who cannot join
- Participants who would have difficulty participating in a trial due to non-adherence or substance abuse
- Participants with any of the following abnormal laboratory test results in screening:
- Hemoglobin < 85 g/L
- Neutrophil count < 750 cells/uL
- Platelet count < 50,000 cells/L
- AST or ALT > 5X the upper limit of normal
Show all 10Show fewer
- Creatinine > 250 umol/L
- Participant with a malignancy
- Participant with other significant underlying disease (non-HIV-1) that might impinge upon disease progression or death
- Participant who is pregnant or who is trying to conceive
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Toronto
Toronto, Ontario, M5B 1W8
Maple Leaf Medical Clinic
Toronto, Ontario, M5G 1K2
About this study
Official title: Randomized, Double-blinded, Controlled Trial of Intensive HAART Including Raltegravir, and Maraviroc, on HIV-1 Pro-viral DNA and Reservoir Decay in HIV-1-infected Individuals During the Acute/Early Infection
This trial will investigate the efficacy and safety of intensified antiretroviral treatment that includes raltegravir and maraviroc during the early stages of HIV infection. With the proven efficacy of these antiviral drugs in pre- and post-clinical trials, we would like to investigate the ability of the combination of raltegravir and maraviroc plus a standard HAART backbone to further decrease the viral load in acutely infected treated HIV infected individuals.
Read the detailed description
The trial is a prospective, randomized, double-blinded, placebo-controlled study with follow-up to 5 years. Thirty-two individuals presenting with newly diagnosed acute or early HIV-1 infection as described in the inclusion criteria will be enrolled, with sixteen randomized to each arm. Individuals will be randomized to one of two arms: the "Intensive" arm with standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400mg /ritonavir 100mg BID) + Raltegravir + Maraviroc or the "placebo" arm with standard HAART+ Placebo for 48 weeks. Another group of individuals diagnosed with acute or early HIV-1 who elect to forego early treatment will be followed as non-randomized, untreated controls. At week 48, all patients will be informed of study results. If results are positive in the intensive treatment group, the placebo group will be offered to roll-over to the intense treatment arm and followed as an open-label cohort out to five years. Participants may stop treatment at any time and withdraw from the study. If they choose to do so, they will be followed according to the standards employed for all HIV-1 patients at the Maple Leaf clinic. At the five year point, the decision to terminate treatment will be made based on the existing state of the HIV-1 literature at the time.
- Conditions
- Acute HIV Infection
- Being tested
- raltegravir, maraviroc, emtricitabine 200mg /tenofovir 300mg, lopinavir 400 mg/ritonavir 100mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
raltegravirDrug
Also called Isentress, MK-0518
Raltegravir 400 mg BID + Maraviroc 150mg BID in addition to standard HAART
maravirocDrug
Also called Celsentri, Selzentry
Raltegravir 400 mg BID + Maraviroc 150mg BID in addition to standard HAART
emtricitabine 200mg /tenofovir 300mgDrug
Also called Truvada
emtricitabine 200mg /tenofovir 300mg QD
lopinavir 400 mg/ritonavir 100mgDrug
Also called Kaletra, Aluvia
lopinavir 400 mg/ritonavir 100mg BID
| Study group | Role | What they receive |
|---|---|---|
| Intensive HAART | Experimental | Patients in this arm will receive the following HAART regimen:
Raltegravir 400 mg BID + Maraviroc 150mg BID + emtricitabine 200mg /tenofovir 300mg QD + lopinavir 400 mg/ritonavir 100mg BID for 96 weeks Receives: Drug: raltegravir; Drug: maraviroc; Drug: emtricitabine 200mg /tenofovir 300mg; Drug: lopinavir 400 mg/ritonavir 100mg |
| Placebo Arm | Placebo comparator | Placebo (in place of raltegravir and maraviroc) will be added to standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400 mg/ritonavir 100mg BID) for 48 weeks and then offered open label Raltegravir and Maraviroc after 48 weeks Receives: Drug: emtricitabine 200mg /tenofovir 300mg; Drug: lopinavir 400 mg/ritonavir 100mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Proviral HIV-1 DNA in Total CD4+ T-cells From Baseline to Week 48 in Participants Randomized to the Intensified Arm Versus the Control Arm Who Received Placebo in Addition to Standard HAART.
The level of HIV Provirus in CD4 T cells obtained from peripheral blood at 48 weeks compared to baseline. A quantitative HIV PCR assay was done. The mean/median values from the standard HAART group is compared to the intensive HAART treatment regimen.
Measured: Baseline to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startNov 2011
- Primary completionSep 2014
- Study completionSep 2014
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 Acute HIV InfectionStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto, Maple Leaf Research
- Responsible party
- Principal investigator, Mario Ostrowski, University of Toronto
- Investigators
- Mario Ostrowski, MD, Principal investigator, University of TorontoColin Kovacs, MD, Principal investigator, Maple Leaf Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01154673
- Sponsor's protocol ID
- 041009
- Status last verified
- Mar 2016
- First submitted
- 29 Jun 2010
- Last updated
- 5 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blinded, Controlled Trial of Intensive HAART Including Raltegravir, and Maraviroc, on HIV-1 Pro-viral DNA and Reservoir Decay in HIV-1-infected Individuals During the Acute/Early Infection
- ClinicalTrials.gov ID
- NCT01154673
- Acronym / sponsor ID
- 041009
- Conditions
- Acute HIV Infection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Unity Health Toronto, Maple Leaf Research
- Study start
- Nov 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 1 Jul 2010 (estimated)
- Results
- Posted 5 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will investigate the efficacy and safety of intensified antiretroviral treatment that includes raltegravir and maraviroc during the early stages of HIV infection. With the proven efficacy of these antiviral drugs in pre- and post-clinical trials, we would like to investigate the ability of the combination of raltegravir and maraviroc plus a standard HAART backbone to further decrease the viral load in acutely infected treated HIV infected individuals.
Detailed description
The trial is a prospective, randomized, double-blinded, placebo-controlled study with follow-up to 5 years. Thirty-two individuals presenting with newly diagnosed acute or early HIV-1 infection as described in the inclusion criteria will be enrolled, with sixteen randomized to each arm. Individuals will be randomized to one of two arms: the "Intensive" arm with standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400mg /ritonavir 100mg BID) + Raltegravir + Maraviroc or the "placebo" arm with standard HAART+ Placebo for 48 weeks. Another group of individuals diagnosed with acute or early HIV-1 who elect to forego early treatment will be followed as non-randomized, untreated controls. At week 48, all patients will be informed of study results. If results are positive in the intensive treatment group, the placebo group will be offered to roll-over to the intense treatment arm and followed as an open-label cohort out to five years. Participants may stop treatment at any time and withdraw from the study. If they choose to do so, they will be followed according to the standards employed for all HIV-1 patients at the Maple Leaf clinic. At the five year point, the decision to terminate treatment will be made based on the existing state of the HIV-1 literature at the time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive HAART | Experimental | Drug: raltegravir, Drug: maraviroc, Drug: emtricitabine 200mg /tenofovir 300mg, Drug: lopinavir 400 mg/ritonavir 100mgPatients in this arm will receive the following HAART regimen: Raltegravir 400 mg BID + Maraviroc 150mg BID + emtricitabine 200mg /tenofovir 300mg QD + lopinavir 400 mg/ritonavir 100mg BID for 96 weeks |
| Placebo Arm | Placebo comparator | Drug: emtricitabine 200mg /tenofovir 300mg, Drug: lopinavir 400 mg/ritonavir 100mgPlacebo (in place of raltegravir and maraviroc) will be added to standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400 mg/ritonavir 100mg BID) for 48 weeks and then offered open label Raltegravir and Maraviroc after 48 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The major single criterion for inclusion into the study will be the presence of confirmed acute/early HIV-1 infection, as defined by one of the three following criteria:
- Positive HIV-1 antibody test result (Western blot), with a documented negative test result in the previous six months or
- Positive or weakly positive HIV-1 antibody screening ELISA test result, with indeterminate and evolving confirmatory test result with demonstrated HIV-1 antigenemia (p24 antigen test result) or viremia (HIV-1 bDNA ≥ 500 copies/ml) or
- Negative HIV-1 antibody test result in the setting of an illness compatible with acute seroconversion with demonstrated HIV-1 antigenemia (p24 antigen test result) or plasma viremia (HIV-1 bDNA ≥ 500 copies/ml)
- Ages 18 or older
Key exclusion criteria (10 listed)
- Participants who would have difficulty participating in a trial due to non-adherence or substance abuse
- Participants with any of the following abnormal laboratory test results in screening:
- Participant with a malignancy
- Participant with other significant underlying disease (non-HIV-1) that might impinge upon disease progression or death
- Participant who is pregnant or who is trying to conceive
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 |
|---|---|---|
| raltegravirAlso: Isentress, MK-0518Raltegravir 400 mg BID + Maraviroc 150mg BID in addition to standard HAART | Drug | Intensive HAART |
| maravirocAlso: Celsentri, SelzentryRaltegravir 400 mg BID + Maraviroc 150mg BID in addition to standard HAART | Drug | Intensive HAART |
| emtricitabine 200mg /tenofovir 300mgAlso: Truvadaemtricitabine 200mg /tenofovir 300mg QD | Drug | Intensive HAART, Placebo Arm |
| lopinavir 400 mg/ritonavir 100mgAlso: Kaletra, Aluvialopinavir 400 mg/ritonavir 100mg BID | Drug | Intensive HAART, Placebo Arm |
Primary outcome
Change in Proviral HIV-1 DNA in Total CD4+ T-cells From Baseline to Week 48 in Participants Randomized to the Intensified Arm Versus the Control Arm Who Received Placebo in Addition to Standard HAART.
Time frame: Baseline to Week 48
The level of HIV Provirus in CD4 T cells obtained from peripheral blood at 48 weeks compared to baseline. A quantitative HIV PCR assay was done. The mean/median values from the standard HAART group is compared to the intensive HAART treatment regimen.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2016.
- 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.
Mario Ostrowski, MD principal investigator
University of Toronto
Colin Kovacs, MD principal investigator
Maple Leaf Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing raltegravir, maraviroc and emtricitabine 200mg /tenofovir 300mg in people with Acute HIV Infection, run by University of Toronto at 2 sites in Canada.
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 8 inclusion and 10 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 5 Apr 2016. 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 Canada. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 5 Apr 2016). 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?
Change in Proviral HIV-1 DNA in Total CD4+ T-cells From Baseline to Week 48 in Participants Randomized to the Intensified Arm Versus the Control Arm Who Received Placebo in Addition to Standard HAART. (time frame: Baseline to Week 48). 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 5 Apr 2016.