HIV InfectionsPhase 4NCT01173510
A Pilot Study to Determine if Raltegravir Eradicates HIV From Peripheral Blood Mononuclear Cells
A Phase 4 study testing Raltegravir plus Truvada and Atripla in people with HIV Infections and Acquired Immune Deficiency Syndrome, run by Community Research Initiative of New England.
Trial summary
Human Immunodeficiency Virus (HIV) infection is permanently established by integrating a deoxyribonucleic acid (DNA) copy into the human chromosome, a step also necessary to complete the Human Immunodeficiency Virus (HIV)replication cycle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Acquired Immune Deficiency Syndrome
- What is being tested?
- Raltegravir plus Truvada and Atripla
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 23 Aug 2010to 19 Oct 2012
- 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
- Male or female subjects age 18 or older with HIV-1 infection
- CD4 cell counts greater than 200 cells/mm at screening
- Plasma HIV RNA > 1000 copies/mL
- Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to eight weeks after the last dose of study drug. Women of childbearing potential includes any woman who has experienced menarche and who has not undergone successful surgical sterilization or who is not post-menopausal.
Who cannot join
- Previous exposure to antiretroviral medications used in the treatment of HIV-1 infection
- Evidence of genotypic or phenotypic resistance to most of the medications that will be used in the study (tenofovir, emtricitabine, and efavirenz) on a resistance assay obtained through the patient's primary care physicians as a standard of care test
- Women with a positive pregnancy test, who are pregnant, or who are breast feeding
- Sexually active non-sterilized men not using effective birth control if they have female partners who are of child-bearing potential
- Women of child-bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to eight weeks after the last dose of study drug
- Presence of any currently active AIDS-defining category C conditions according to the CDC Classification System for HIV Infection with the exception of stable cutaneous Kaposi's sarcoma
Show all 12Show fewer
- Any active, clinically significant disease that in the opinion of the Principal Investigator may compromise the subject's safety during the trial
- Grade 3 or 4 Laboratory abnormalities as defined by a standardized grading scheme based on the DAIDS table - ACTG Toxicity Grading Scale elevations (except pre-existing diabetes mellitus with asymptomatic, non-fasting glucose grade 3 elevations, asymptomatic ≥ grade 3 fasting triglyceride or cholesterol elevations, and subjects with elevated indirect bilirubin)
- Active substance abuse or significant psychiatric illness that in the opinion of the Principal Investigator may interfere with study compliance
- Prisoners or subjects who are involuntarily incarcerated
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness
- Known hypersensitivity to G-CSF
About this study
Human Immunodeficiency Virus (HIV) infection is permanently established by integrating a deoxyribonucleic acid (DNA) copy into the human chromosome, a step also necessary to complete the Human Immunodeficiency Virus (HIV)replication cycle. Standard treatment of HIV infection suppresses Human Immunodeficiency Virus (HIV)replication and has not been able to eliminate Human Immunodeficiency Virus (HIV)from an infected person because of the integrated Human Immunodeficiency Virus (HIV). Raltegravir (RAL), the first approved antiretroviral (ARV) in a new class called integrase inhibitors, works by preventing integration of Human Immunodeficiency Virus (HIV). For participants with Human Immunodeficiency Virus (HIV)who have never taken antiretroviral medications, this research study will test whether Raltegravir (RAL), a recommended first-line ARV, can eliminate Human Immunodeficiency Virus (HIV)from key immune system cells.
Read the detailed description
This is a phase IV study comparing RAL to EFV ability to clear the HIV from mononuclear cells. Participants will be randomized 2:1 to either RAL plus co-formulated FTC/TDF or EFV/FTC/TDF (Atripla). The study will last a minimum of 24 weeks. Participants will come in three days before the weeks 4 and 24 visits to receive a subcutaneous injection of G-CSF, an FDA-approved medication that mobilizes certain cells. A minimum of 5 visits will be required after baseline for blood draws, safety monitoring, or G-CSF injections.
- Being tested
- Raltegravir plus Truvada, Atripla
- Keywords
- HIV, AIDS, Atripla, Truvada, Raltegravir, Human Immunodeficiency Virus, Acquired Immune Deficiency Syndrome Virus
- 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 plus TruvadaDrug
Raltegravir 400 mg twice daily plus tenofovir/emtricitabine (Truvada) one tablet once daily
AtriplaDrug
Efavirenz/Emtricitabine/Tenofovir DF one tablet once daily
| Study group | Role | What they receive |
|---|---|---|
| Raltegravir plus tenofovir/emtricitabine | Experimental | Not described Receives: Drug: Raltegravir plus Truvada |
| Efavirenz/Emtricitabine/Tenofovir | Active comparator | Not described Receives: Drug: Atripla |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy in eradicated HIV-1 integrated DNA from PBMCs
To study the efficacy of Raltegravir plus Tenofovir DF/Emtricitabine versus Efavirenz/Emtricitabine/Tenofovir DF in eradicating HIV-1 integrated DNA from peripheral blood mononuclear cells (PBMCs) in healthy HIV-infected participants who are naïve to antiretroviral therapy.
Measured: 24 weeks
Efficacy in eradicating HIV-1 integrated DNA from CD34+ cells
To study the efficacy of Raltegravir plus Tenofovir DF/Emtricitabine versus Efavirenz/Emtricitabine/Tenofovir DF in eradicating HIV-1 integrated DNA from CD34+ cells mobilized from the bone marrow in healthy HIV-infected participants who are naïve to antiretroviral therapy.
Measured: 24 weeks
Secondary outcomes (4)
Efficacy in eradicating PBMC-associated early viral spliced mRNA
To study the efficacy of Raltegravir plus Tenofovir DF/Emtricitabine versus Efavirenz/Emtricitabine/Tenofovir DF in eradicating PBMC-associated early viral spliced mRNA (tat, rev, and nef) in healthy HIV-infected participants who are naïve to antiretroviral therapy.
Measured: 24 weeks
Efficacy in eradicating PBMC-associated viral genomic RNA
To study the efficacy of Raltegravir plus Tenofovir DF/Emtricitabine versus Efavirenz/Emtricitabine/Tenofovir DF in eradicating PBMC-associated viral genomic RNA in healthy HIV-infected participants who are naïve to antiretroviral therapy.
Measured: 24 weeks
Efficacy in eradicating CD34+-cell-associated early viral spliced mRNA
To study the efficacy of Raltegravir plus Tenofovir DF/Emtricitabine versus Efavirenz/Emtricitabine/Tenofovir DF in eradicating CD34+-cell-associated early viral spliced mRNA (tat, rev, and nef) in healthy HIV-infected participants who are naïve to antiretroviral therapy.
Measured: 24 weeks
Efficacy in eradicating CD34+-cell-associated viral genomic RNA
To study the efficacy of Raltegravir plus Tenofovir DF/Emtricitabine versus Efavirenz/Emtricitabine/Tenofovir DF in eradicating CD34+cell-associated viral genomic RNA in healthy HIV-infected participants who are naïve to antiretroviral therapy.
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 posted2 Aug 2010 (estimated)
- Study start23 Aug 2010 (estimated)
- Primary completion19 Oct 2012
- Study completion19 Oct 2012
Why it stopped: This study was not feasible due to facility budget and contractual issues.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Community Research Initiative of New England
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Clyde S Crumpacker, MD, Principal investigator, Beth Israel Deaconess Medical Center - Division of Infectious DiseaseCalvin J Cohen, MD, Principal investigator, Community Research Initiative of New England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173510
- Sponsor's protocol ID
- 10-184
- Status last verified
- Jun 2017
- First submitted
- 29 Jul 2010
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine if Raltegravir Eradicates HIV From Peripheral Blood Mononuclear Cells
- ClinicalTrials.gov ID
- NCT01173510
- Acronym / sponsor ID
- 10-184
- Keywords
- HIV, AIDS, Atripla, Truvada, Raltegravir, Human Immunodeficiency Virus, Acquired Immune Deficiency Syndrome Virus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was not feasible due to facility budget and contractual issues.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Community Research Initiative of New EnglandUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 23 Aug 2010 (estimated)
- Primary completion
- 19 Oct 2012 (actual)
- Study completion
- 19 Oct 2012 (actual)
- First posted
- 2 Aug 2010 (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.
Human Immunodeficiency Virus (HIV) infection is permanently established by integrating a deoxyribonucleic acid (DNA) copy into the human chromosome, a step also necessary to complete the Human Immunodeficiency Virus (HIV)replication cycle. Standard treatment of HIV infection suppresses Human Immunodeficiency Virus (HIV)replication and has not been able to eliminate Human Immunodeficiency Virus (HIV)from an infected person because of the integrated Human Immunodeficiency Virus (HIV). Raltegravir (RAL), the first approved antiretroviral (ARV) in a new class called integrase inhibitors, works by preventing integration of Human Immunodeficiency Virus (HIV). For participants with Human Immunodeficiency Virus (HIV)who have never taken antiretroviral medications, this research study will test whether Raltegravir (RAL), a recommended first-line ARV, can eliminate Human Immunodeficiency Virus (HIV)from key immune system cells.
Detailed description
This is a phase IV study comparing RAL to EFV ability to clear the HIV from mononuclear cells. Participants will be randomized 2:1 to either RAL plus co-formulated FTC/TDF or EFV/FTC/TDF (Atripla). The study will last a minimum of 24 weeks. Participants will come in three days before the weeks 4 and 24 visits to receive a subcutaneous injection of G-CSF, an FDA-approved medication that mobilizes certain cells. A minimum of 5 visits will be required after baseline for blood draws, safety monitoring, or G-CSF injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Raltegravir plus tenofovir/emtricitabine | Experimental | Drug: Raltegravir plus Truvada |
| Efavirenz/Emtricitabine/Tenofovir | Active comparator | Drug: Atripla |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects age 18 or older with HIV-1 infection
- CD4 cell counts greater than 200 cells/mm at screening
- Plasma HIV RNA > 1000 copies/mL
- Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to eight weeks after the last dose of study drug. Women of childbearing potential includes any woman who has experienced menarche and who has not undergone successful surgical sterilization or who is not post-menopausal.
Key exclusion criteria (12 listed)
- Previous exposure to antiretroviral medications used in the treatment of HIV-1 infection
- Evidence of genotypic or phenotypic resistance to most of the medications that will be used in the study (tenofovir, emtricitabine, and efavirenz) on a resistance assay obtained through the patient's primary care physicians as a standard of care test
- Women with a positive pregnancy test, who are pregnant, or who are breast feeding
- Sexually active non-sterilized men not using effective birth control if they have female partners who are of child-bearing potential
- Women of child-bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to eight weeks after the last dose of study drug
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 plus TruvadaRaltegravir 400 mg twice daily plus tenofovir/emtricitabine (Truvada) one tablet once daily | Drug | Raltegravir plus tenofovir/emtricitabine |
| AtriplaEfavirenz/Emtricitabine/Tenofovir DF one tablet once daily | Drug | Efavirenz/Emtricitabine/Tenofovir |
Primary outcome
Efficacy in eradicated HIV-1 integrated DNA from PBMCs
Time frame: 24 weeks
To study the efficacy of Raltegravir plus Tenofovir DF/Emtricitabine versus Efavirenz/Emtricitabine/Tenofovir DF in eradicating HIV-1 integrated DNA from peripheral blood mononuclear cells (PBMCs) in healthy HIV-infected participants who are naïve to antiretroviral therapy.
Efficacy in eradicating HIV-1 integrated DNA from CD34+ cells
Time frame: 24 weeks
To study the efficacy of Raltegravir plus Tenofovir DF/Emtricitabine versus Efavirenz/Emtricitabine/Tenofovir DF in eradicating HIV-1 integrated DNA from CD34+ cells mobilized from the bone marrow in healthy HIV-infected participants who are naïve to antiretroviral therapy.
4 secondary outcomes
Efficacy in eradicating PBMC-associated early viral spliced mRNA
Time frame: 24 weeks
Efficacy in eradicating PBMC-associated viral genomic RNA
Time frame: 24 weeks
Efficacy in eradicating CD34+-cell-associated early viral spliced mRNA
Time frame: 24 weeks
Efficacy in eradicating CD34+-cell-associated viral genomic RNA
Time frame: 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Community Research Initiative websiteLink provided by the sponsor.
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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.
Clyde S Crumpacker, MD principal investigator
Beth Israel Deaconess Medical Center - Division of Infectious Disease
Calvin J Cohen, MD principal investigator
Community Research Initiative of New England
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Raltegravir plus Truvada and Atripla in people with HIV Infections and Acquired Immune Deficiency Syndrome, run by Community Research Initiative of New England.
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 4 inclusion and 12 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: withdrawn, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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 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 withdrawn before enrolling participants, so there are no results.
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?
Efficacy in eradicated HIV-1 integrated DNA from PBMCs (time frame: 24 weeks). The study lists 2 primary outcomes in all. 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 14 Jun 2017.