HIV InfectionsPhase 2NCT00520897
Integrase Inhibitor (MK-0518) Viral Decay
A Phase 2 study testing Raltegravir (MK0518), Leukopheresis and Sigmoid Biopsy in people with HIV Infections, run by Canadian Immunodeficiency Research Collaborative at 1 site in Canada.
Trial summary
The eradication of HIV by antiretroviral therapy has thus far been elusive. It has been consistently demonstrated that a pool of latently infected, resting CD4+ T cells persists in the majority of HIV-infected individuals receiving antiretroviral therapy in whom plasma viremia has been successfully suppressed for… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Raltegravir (MK0518), Leukopheresis and Sigmoid Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2007to Nov 2011
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be HIV-1 infected
- Participant must be 18 years old
- Participant must be taking first standard cART with 2-3 NRTIs and 1-2 PIs or an NNRTI for at least four years (first cART regimen may include changes due to toxicity but not due to virologic failure).
- Participant must have a VL < 50 copies/ml (using the standard available methods of detection) during the entire time on standard cART except for initial fall of VL and a maximum of two non-consecutive blips of < 100 copies/ml that the study investigator deems to be not clinically significant
- Female participant must agree to use two methods of birth control or abstinence during the period of the study
- Participant has to have signed full informed consent
Who cannot join
- Participant who would have difficulty participating in a trial due to non-adherence or substance abuse
- Participant who has taken mono or dual antiretroviral therapy in the past
- Participant who has had a VL > 50 copies/ml on any antiretroviral regimen
- Participant with any of the following abnormal laboratory test results in screening:
- Hemoglobin < 100 g/L
- Neutrophil count < 750 cells/L
Show all 13Show fewer
- Platelet count < 50,000 cells/L
- AST or ALT > 5X the upper limit of normal
- Creatinine > 250 mol/L
- Participant with a malignancy
- Participant with other significant underlying disease (non-HIV) that might impinge upon disease progression or death
- Participant with an active AIDS-defining illness in the past six months
- Participant who is pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Integrase Inhibitor (MK-0518) on Decay of Low Level Viral Replication in HIV Reservoirs in Infected Individuals Who Initiated Conventional Antiretroviral Therapy During the Chronic Phase of Infection
The eradication of HIV by antiretroviral therapy has thus far been elusive. It has been consistently demonstrated that a pool of latently infected, resting CD4+ T cells persists in the majority of HIV-infected individuals receiving antiretroviral therapy in whom plasma viremia has been successfully suppressed for prolonged periods of time; this pool has emerged as the major obstacle in achieving the eradication of HIV. We believe that MK-0518 can further the decay and suppression of HIV-1 in patients who have been virologically suppressed for a prolonged period of time on effective cART (≥ 4 years).
Read the detailed description
The trial is a prospective, double-blind, randomized, placebo-controlled study with two phases: phase I to 48 weeks and phase II to 96 weeks with the primary analysis at 48 weeks. HIV-infected individuals who are taking their first standard cART regimen for at least four years with complete viral suppression. Upon enrollment, he/she will be randomized to one of two arms: the MK-0518 arm or the control arm. As each participant reaches week 48, he/she will be unblinded and those in the MK-0518 arm will continue taking MK-0518. Based on the results of an interim analysis, the control arm will be rolled over to receive MK-0518 for 48 weeks. After the screening, baseline visits and week 4 safety visit, follow-up visits will occur every 8 weeks for both arms.
- Conditions
- HIV Infections
- Being tested
- Raltegravir (MK0518), Placebo, Leukopheresis, Sigmoid Biopsy
- Keywords
- chronic HIV infection, Human Immunodeficiency Virus, Treatment Experienced
- 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.
Raltegravir (MK0518)Drug
400mg BID; 48 weeks
PlaceboDrug
400mg QD
LeukopheresisProcedure or surgery
pack of cells as per protocol
Sigmoid BiopsyProcedure or surgery
gut samples as per protocol
| Study group | Role | What they receive |
|---|---|---|
| MK0518 + cART | Experimental | Raltegravir + standard of care combined antiretroviral therapy Receives: Drug: Raltegravir (MK0518); Procedure: Leukopheresis; Procedure: Sigmoid Biopsy |
| Placebo + cART | Placebo comparator | Placebo + standard of care combined antiretroviral therapy Receives: Drug: Placebo; Procedure: Leukopheresis; Procedure: Sigmoid Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of proviral HIV-1 DNA in total CD4+ T cells from baseline to week 48
evaluate the change of proviral HIV-1 DNA in total CD4+ T cells from baseline to week 48 in participants randomized to the raltegravir arm (400mg raltegravir) for 48 weeks in addition to their current standard combination antiretroviral regimen versus the control arm, who remained on their current standard combination antiretroviral regimen.
Measured: 48 weeks
Secondary outcomes (1)
evaluated the effect of raltegravir intensification on blood CD4+ T cell populations
evaluated the effect of raltegravir intensification on blood CD4+ T cell populations. In addition, after treatment-intensification in both groups at week 48, a post-hoc follow-up of all participants was conducted up to week 96 to examine if raltegravir intensification had any long-term effects on proviral HIV DNA and CD4+ T cell populations in the blood and gut.
Measured: 48 & 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2007 (estimated)
- Study startApr 2007
- Primary completionFeb 2009
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Immunodeficiency Research Collaborative
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Mona Loutfy, MD, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520897
- Sponsor's protocol ID
- 038-00
- Status last verified
- Jun 2012
- First submitted
- 24 Aug 2007
- Last updated
- 5 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Integrase Inhibitor (MK-0518) on Decay of Low Level Viral Replication in HIV Reservoirs in Infected Individuals Who Initiated Conventional Antiretroviral Therapy During the Chronic Phase of Infection
- ClinicalTrials.gov ID
- NCT00520897
- Acronym / sponsor ID
- 038-00
- Conditions
- HIV Infections
- Keywords
- chronic HIV infection, Human Immunodeficiency Virus, Treatment Experienced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Canadian Immunodeficiency Research CollaborativeUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Apr 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 27 Aug 2007 (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 eradication of HIV by antiretroviral therapy has thus far been elusive. It has been consistently demonstrated that a pool of latently infected, resting CD4+ T cells persists in the majority of HIV-infected individuals receiving antiretroviral therapy in whom plasma viremia has been successfully suppressed for prolonged periods of time; this pool has emerged as the major obstacle in achieving the eradication of HIV. We believe that MK-0518 can further the decay and suppression of HIV-1 in patients who have been virologically suppressed for a prolonged period of time on effective cART (≥ 4 years).
Detailed description
The trial is a prospective, double-blind, randomized, placebo-controlled study with two phases: phase I to 48 weeks and phase II to 96 weeks with the primary analysis at 48 weeks. HIV-infected individuals who are taking their first standard cART regimen for at least four years with complete viral suppression. Upon enrollment, he/she will be randomized to one of two arms: the MK-0518 arm or the control arm. As each participant reaches week 48, he/she will be unblinded and those in the MK-0518 arm will continue taking MK-0518. Based on the results of an interim analysis, the control arm will be rolled over to receive MK-0518 for 48 weeks. After the screening, baseline visits and week 4 safety visit, follow-up visits will occur every 8 weeks for both arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MK0518 + cART | Experimental | Drug: Raltegravir (MK0518), Procedure: Leukopheresis, Procedure: Sigmoid BiopsyRaltegravir + standard of care combined antiretroviral therapy |
| Placebo + cART | Placebo comparator | Drug: Placebo, Procedure: Leukopheresis, Procedure: Sigmoid BiopsyPlacebo + standard of care combined antiretroviral therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant must be HIV-1 infected
- Participant must be 18 years old
- Participant must be taking first standard cART with 2-3 NRTIs and 1-2 PIs or an NNRTI for at least four years (first cART regimen may include changes due to toxicity but not due to virologic failure).
- Participant must have a VL < 50 copies/ml (using the standard available methods of detection) during the entire time on standard cART except for initial fall of VL and a maximum of two non-consecutive blips of < 100 copies/ml that the study investigator deems to be not clinically significant
- Female participant must agree to use two methods of birth control or abstinence during the period of the study
Key exclusion criteria (13 listed)
- Participant who would have difficulty participating in a trial due to non-adherence or substance abuse
- Participant who has taken mono or dual antiretroviral therapy in the past
- Participant who has had a VL > 50 copies/ml on any antiretroviral regimen
- Participant with any of the following abnormal laboratory test results in screening:
- Participant with a malignancy
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 |
|---|---|---|
| Raltegravir (MK0518)400mg BID; 48 weeks | Drug | MK0518 + cART |
| Placebo400mg QD | Drug | Placebo + cART |
| Leukopheresispack of cells as per protocol | Procedure or surgery | MK0518 + cART, Placebo + cART |
| Sigmoid Biopsygut samples as per protocol | Procedure or surgery | MK0518 + cART, Placebo + cART |
Primary outcome
change of proviral HIV-1 DNA in total CD4+ T cells from baseline to week 48
Time frame: 48 weeks
evaluate the change of proviral HIV-1 DNA in total CD4+ T cells from baseline to week 48 in participants randomized to the raltegravir arm (400mg raltegravir) for 48 weeks in addition to their current standard combination antiretroviral regimen versus the control arm, who remained on their current standard combination antiretroviral regimen.
1 secondary outcome
evaluated the effect of raltegravir intensification on blood CD4+ T cell populations
Time frame: 48 & 96 weeks
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 5 Jun 2012.
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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.
Mona Loutfy, MD principal investigator
Women's College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Raltegravir (MK0518), Leukopheresis and Sigmoid Biopsy in people with HIV Infections, run by Canadian Immunodeficiency Research Collaborative at 1 site 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 6 inclusion and 13 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 Jun 2012. 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 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 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.
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 of proviral HIV-1 DNA in total CD4+ T cells from baseline to week 48 (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 5 Jun 2012.