HIV InfectionsPhase 3CHEERNCT00529243
Evaluating the Effect of CHanging EnfuvirtidE to Raltegravir in HIV Infected Subjects
A Phase 3 study testing raltegravir in people with HIV Infections, run by Kaiser Permanente at 8 sites in United States.
Trial summary
The primary objective of this study is: To assess the virologic effect of changing enfuvirtide to MK-0518(raltegravir) in human immunodeficiency virus type 1(HIV-1) infected patients who have an undetectable level of serum human immunodeficiency virus(HIV) (< 75 copies/ml by branch deoxyribonucleic acid (bDNA) assay… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- raltegravir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 8 sitesUnited States
- Study dates
- Sep 2007to Sep 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following inclusion criteria to be eligible for participation in this study.
- Subject is ≥ 18 years of age and able to understand and willing to sign a written informed consent form, which must be obtained prior to initiation of the study.
- Documented laboratory diagnosis of HIV-1 infection (positive Enzyme-linked immunosorbent assay (ELISA) HIV-1 antibody test confirmed by western blot, p24 assay, HIV-1 RNA, or culture).
- Have documented plasma HIV-1 RNA level(s) of < 75 copies/ml by branched deoxyribonucleic acid(bDNA) assay, or < 50 copies/ml by Ultrasensitive Polymerase Chain Reaction(PCR) for at least 6 months prior to screening visit.
- Currently receiving a stable antiretroviral regimen consisting of enfuvirtide plus at least 2 other antiretrovirals for at least 6 months.
- Negative serum pregnancy test (females of childbearing potential only) and are willing to use an adequate method of contraception throughout the duration of the study.
Who cannot join
- Patients who meet any of the following exclusion criteria are not to be enrolled in this study.
- Any prior therapy with MK-0518 or any other HIV-1 integrase inhibitor.
- Any HIV-1 viral load > 75 copies/ml by bDNA assay, or > 50 copies/ml by Ultrasensitive PCR assay in the 6 months prior to screening visit (A single "blip" of HIV-1 viral load >75 copies but <400 copies by bDNA assay, or >50 copies but <400 copies by Ultrasensitive PCR assay in the six months prior to screening visit with at least one subsequent HIV-1 viral load below the limit of detection will be accepted.)
- Any previous known hypersensitivity to components of the study drug formulation.
- Weight < 40 kilograms.
- Patient requires or is anticipated to require any of the prohibited medications noted in the protocol.
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- Acute therapy for serious illness (in the opinion of the investigator) within 14 days prior to study entry unless the subject has completed ≥ 7 days of therapy and is considered clinically stable by the investigator.
- Any condition which, in the opinion of the investigator, would compromise the subject's ability to participate in the study.
- Any active opportunistic infections or Centers for Disease Control and Prevention (CDC) Category C conditions (with the exception of stable cutaneous Kaposi's Sarcoma and wasting syndrome due to HIV infection).
- Any malignancy requiring chemotherapy.
- Subject has any of the following laboratory results at screening:
- Hemoglobin < 8.0 gr/dl Absolute neutrophil count < 750 cells/ml Platelet count < 40,000 Creatinine > 2.0 or calculated creatinine clearance < 40 ml/min
- Female patient who is pregnant or breast-feeding, or expecting to conceive or donate eggs during the study. Male patient who is planning to impregnate or provide sperm donation during the study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Kaiser Anaheim
Anaheim, California, 92807
Kaiser Hayward
Hayward, California, 95454
Kaiser Los Angeles
Los Angeles, California, 90027
Kaiser West Los Angeles
Los Angeles, California, 90034
Kaiser Panorama City
Panorama City, California, 91402
Kaiser San Francisco
San Francisco, California, 94118
Kaiser Santa Clara
Santa Clara, California, 95051
Kaiser Santa Clarita
Santa Clarita, California, 91355
About this study
Official title: Virologic Outcomes of Changing Enfuvirtide to Raltegravir in HIV-1 Patients Well Controlled on an Enfuvirtide Based Regimen
The primary objective of this study is:
To assess the virologic effect of changing enfuvirtide to MK-0518(raltegravir) in human immunodeficiency virus type 1(HIV-1) infected patients who have an undetectable level of serum human immunodeficiency virus(HIV) (< 75 copies/ml by branch deoxyribonucleic acid (bDNA) assay, < 50 copies/ml by Ultrasensitive Polymerase Chain Reaction(PCR) assay) on their current HIV medication regimen.
Read more
Hypothesis:
HIV-1 infected individuals well controlled on an enfuvirtide containing regimen with HIV RNA levels below limits of quantification can safely have the investigational integrase inhibitor, MK-0518 substituted for enfuvirtide without loss of virologic suppression.
Read the detailed description
Human immunodeficiency virus type 1(HIV-1) infected patients who have had an undetectable viral load on an enfuvirtide containing regimen at the Kaiser Permanente Hayward, Los Angeles, San Francisco, and Santa Clara Medical Centers will be enrolled. Patients will receive open label MK-0518 (raltegravir) 400mg orally twice a day as substitution for enfuvirtide for 24 weeks.
- Conditions
- HIV Infections
- Being tested
- raltegravir
- Keywords
- Treatment Experience, On enfuvirtide
- 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
Also called MK-0518, Isentress
This is a single-arm, open-label, non-randomized pilot study in human immunodeficiency virus type 1 (HIV-1) positive patients who have an undetectable viral load on their current enfuvirtide containing medication regimen. The treatment regimen will consist of replacing enfuvirtide with MK-0518 400 mg twice a day given as part of the patient's HIV medication regimen. The study regimen will be administered for 24 weeks, with patients given the option of continuing on the study medication past that time if they wish to. Patients serve as their own control as they have viral control (HIV ribonucleic acid (RNA) below limits of quantification) for at least 6 months with enfuvirtide prior to switch to raltegravir.
| Study group | Role | What they receive |
|---|---|---|
| MK-0518 (raltegravir) | Experimental | Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide. Receives: Drug: raltegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Undetectable Human Immunodeficiency Virus (HIV) Viral Load at Week 24.
To assess the virologic effect of changing enfuvirtide to MK-0518 (raltegravir) in human immunodeficiency virus type 1 (HIV-1) infected patients who have an undetectable level of serum HIV (undetectable level of serum HIV defined as < 75 copies/ml by bDNA assay or < 50 copies/ml by Ultrasensitive PCR assay) on their current HIV medication regimen.
Measured: 24 Weeks
Secondary outcomes (1)
Average Change in Cluster of Differentiation 4(CD4) Cell Count From Baseline at Week 24
To study the immunologic effect of changing enfuvirtide to MK-0518 (raltegravir) in HIV-1 infected patients who have an undetectable level of serum HIV (undetectable serum HIV defined as < 75 copies/ml by bDNA assay or < 50 copies/ml by Ultrasensitive PCR assay)on their current HIV medication regimen.
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionJul 2008
- Study completionSep 2009
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 HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- William J Towner, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529243
- Sponsor's protocol ID
- 4908
- Acronym
- CHEER
- Status last verified
- Jul 2018
- First submitted
- 12 Sep 2007
- Last updated
- 7 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virologic Outcomes of Changing Enfuvirtide to Raltegravir in HIV-1 Patients Well Controlled on an Enfuvirtide Based Regimen
- ClinicalTrials.gov ID
- NCT00529243
- Acronym / sponsor ID
- CHEER / 4908
- Conditions
- HIV Infections
- Keywords
- Treatment Experience, On enfuvirtide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Sep 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 14 Sep 2007 (estimated)
- Results
- Posted 8 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is:
To assess the virologic effect of changing enfuvirtide to MK-0518(raltegravir) in human immunodeficiency virus type 1(HIV-1) infected patients who have an undetectable level of serum human immunodeficiency virus(HIV) (< 75 copies/ml by branch deoxyribonucleic acid (bDNA) assay, < 50 copies/ml by Ultrasensitive Polymerase Chain Reaction(PCR) assay) on their current HIV medication regimen.
Hypothesis:
HIV-1 infected individuals well controlled on an enfuvirtide containing regimen with HIV RNA levels below limits of quantification can safely have the investigational integrase inhibitor, MK-0518 substituted for enfuvirtide without loss of virologic suppression.
Detailed description
Human immunodeficiency virus type 1(HIV-1) infected patients who have had an undetectable viral load on an enfuvirtide containing regimen at the Kaiser Permanente Hayward, Los Angeles, San Francisco, and Santa Clara Medical Centers will be enrolled. Patients will receive open label MK-0518 (raltegravir) 400mg orally twice a day as substitution for enfuvirtide for 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MK-0518 (raltegravir) | Experimental | Drug: raltegravirOpen label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must meet all of the following inclusion criteria to be eligible for participation in this study.
Key exclusion criteria (13 listed)
- Patients who meet any of the following exclusion criteria are not to be enrolled in this study.
- Hemoglobin < 8.0 gr/dl Absolute neutrophil count < 750 cells/ml Platelet count < 40,000 Creatinine > 2.0 or calculated creatinine clearance < 40 ml/min
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: MK-0518, IsentressThis is a single-arm, open-label, non-randomized pilot study in human immunodeficiency virus type 1 (HIV-1) positive patients who have an undetectable viral load on their current enfuvirtide containing medication regimen. The treatment regimen will consist of replacing enfuvirtide with MK-0518 400 mg twice a day given as part of the patient's HIV medication regimen. The study regimen will be administered for 24 weeks, with patients given the option of continuing on the study medication past that time if they wish to. Patients serve as their own control as they have viral control (HIV ribonucleic acid (RNA) below limits of quantification) for at least 6 months with enfuvirtide prior to switch to raltegravir. | Drug | MK-0518 (raltegravir) |
Primary outcome
Number of Patients With Undetectable Human Immunodeficiency Virus (HIV) Viral Load at Week 24.
Time frame: 24 Weeks
To assess the virologic effect of changing enfuvirtide to MK-0518 (raltegravir) in human immunodeficiency virus type 1 (HIV-1) infected patients who have an undetectable level of serum HIV (undetectable level of serum HIV defined as < 75 copies/ml by bDNA assay or < 50 copies/ml by Ultrasensitive PCR assay) on their current HIV medication regimen.
1 secondary outcome
Average Change in Cluster of Differentiation 4(CD4) Cell Count From Baseline at Week 24
Time frame: 24 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- 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.
William J Towner, MD principal investigator
Kaiser Permanente
8 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 in people with HIV Infections, run by Kaiser Permanente at 8 sites 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 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 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 8 Jun 2011). 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 With Undetectable Human Immunodeficiency Virus (HIV) Viral Load at Week 24. (time frame: 24 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 7 Aug 2018.