HIV InfectionsPhase 1NCT00496782
Multicenter Pilot Study To Define The Marker As An Alternate For Tropism Assay
A Phase 1 study testing maraviroc and Trofile Assay and HIV RNA quantification assay in people with HIV Infections, run by ViiV Healthcare at 10 sites in 2 countries.
Trial summary
The purpose of this pilot study is to determine whether there is a correlation between viral load reduction (at Day 4, 7 or 14) following a short course (14 days) of Maraviroc added to a failing regimen, and the R5 result of the TrofileTM assay at screening. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- maraviroc and Trofile Assay and HIV RNA quantification assay
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Jul 2007to Oct 2008
- Phase
- Phase 1
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ≥ 16 years of age (or minimum adult age as determined by local regulatory authorities or as dictated by local law) at the screening visit.
- Have an HIV RNA ≥ 1000 copies/mL, at screening.
- Subjects receiving another investigational antiretroviral compound through participation in a phase 3 or 4 clinical study are eligible to participate in this trial provided.
- That the 2 investigational agents are required to offer the subject a regimen with 2 or 3 active antiretroviral drugs (i.e. one or fewer approved treatment is available to the subject due to prior resistance or intolerance),
- Neither protocol prohibits the use of the other antiretroviral agent, AND the dosing of the two agents when used together is known AND a letter from the Pfizer clinical pharmacologists for maraviroc identifies the dose of maraviroc to be used with other investigational agents.
- Based on screening genotypic resistance testing results the subject must be able to receive at least 3 active drugs other than maraviroc in the new OBT. This is defined as:
- Having three drugs considered susceptible by genotype interpretation (if etravirine will be used, fewer than 3 etravirine resistance mutations will be taken as etravirine susceptibility); or,
- Having two drugs considered susceptible by genotype interpretation (if etravirine will be used, fewer than 3 etravirine resistance mutations will be taken as etravirine susceptibility) and be willing to include raltegravir in the OBT not having used raltegravir in the past.
Who cannot join
- Potentially life threatening (Grade 4) laboratory abnormality or medical condition.
- Severe hepatic impairment (Child-Pugh classification B or C).
- End stage renal disease or other disease states requiring dialysis therapy.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Pfizer Investigational Site
Buffalo, New York, 14215
Pfizer Investigational Site
Chicago, Illinois, 60613
Pfizer Investigational Site
Detroit, Michigan, 48202
Pfizer Investigational Site
Hampton, Virginia, 23666
Pfizer Investigational Site
Miami, Florida, 33137
Pfizer Investigational Site
Omaha, Nebraska, 68198-5400
Pfizer Investigational Site
Topeka, Kansas, 66606-1670
Pfizer Investigational Site
Topeka, Kansas, 66606
Pfizer Investigational Site
Tulsa, Oklahoma, 74135
About this study
Official title: Surrogate Marker For Tropism-A Multi-Center, Open Label, Pilot Study
The purpose of this pilot study is to determine whether there is a correlation between viral load reduction (at Day 4, 7 or 14) following a short course (14 days) of Maraviroc added to a failing regimen, and the R5 result of the TrofileTM assay at screening.
Read the detailed description
The study A4001060 has been discontinued on April 22, 2008. A review of the poor rate of enrollment has projected difficulties in completing the study in a timely manner, despite the best efforts by the sponsor and the sites. Given the difficulties encountered in this pilot study and the need to conduct an even larger confirmatory study, the decision to discontinue the study has therefore been made. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.
- Conditions
- HIV Infections
- Being tested
- maraviroc, Trofile Assay and HIV RNA quantification assay
- Keywords
- Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maravirocDrug
Treatment-experienced subjects on failed therapy, with HIV RNA ≥ 1000 copies/mL, are eligible who will receive a tropism assay at screening (Day -14 to 0). Subjects who are eligible will receive maraviroc added to a failing regimen from Day 1 to 14. On day 15, subjects will discontinue the current treatment regimen and begin a new OBT. Subjects with only R5 HIV will continue receiving maraviroc plus OBT. Subjects with non-R5 virus will discontinue receiving maraviroc but continue to receive the new OBT. Investigator selects OBT based on results of phenotype/genotype testing at baseline. The nominal dose for maraviroc is 300 mg BID. The maraviroc dose should be adjusted based on OBT patient is taking. If OBT includes CYP3A4 inhibitor (with or without inducers) maraviroc dose should be 150 mg BID and if OBT includes CYP3A4 inducer (without inhibitors) maraviroc dose should be 600mg BID. If OBT does not include any CYP3A4 inducers or inhibitors maraviroc dose should be 300 mg BID.
Trofile Assay and HIV RNA quantification assayProcedure or surgery
Trofile Assay and HIV RNA quantification assay
| Study group | Role | What they receive |
|---|---|---|
| Single | Other | Not described Receives: Drug: maraviroc; Procedure: Trofile Assay and HIV RNA quantification assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) With R5 & Non-R5 Tropism Results From the Trofile(tm) Assay
Spearman's correlation coefficient to assess percentage of participants achieving HIV-1 RNA with tropism
Measured: Baseline, Day 4, 7, 14
Secondary outcomes (13)
Subjects Achieving HIV-1 RNA <400 Copies/mL
Number of Subjects Achieving HIV-1 RNA <400 Copies/mL at each time point
Measured: Days 4, 7, 14, 28, and Weeks 8, 12, 18, and 24
Subjects Achieving HIV-1 RNA <50 Copies/mL
Number of Subjects Achieving HIV-1 RNA <50 Copies/mL at each time point
Measured: Days 4, 7, 14, 28, and Weeks 8, 12, 18, and 24
Subjects With Virologic Failure
For this protocol, virologic failure will be confirmed by a repeat viral load test within 2 weeks of first viral load meeting any of the following criteria: 1. Failing to achieve a reduction in HIV-1 RNA > 0.5 log10 copies/mL from baseline by the second viral load determination (unless the viral load is below level of quantification [LOQ]); 2. Experiencing a > 0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from baseline > 0.5 log10 copies/mL; or 3. Experiencing an HIV-1 RNA >1000 copies/mL after having achieved an HIV-1 RNA below LOQ.
Measured: Baseline up to Week 24
Time to Virologic Failure
For this protocol, virologic failure will be confirmed by a repeat viral load test within 2 weeks of first viral load meeting any of the following criteria: 1. Failing to achieve a reduction in HIV-1 RNA > 0.5 log10 copies/mL from baseline by the second viral load determination (unless the viral load is below level of quantification [LOQ]); 2. Experiencing a > 0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from baseline > 0.5 log10 copies/mL; or 3. Experiencing an HIV-1 RNA >1000 copies/mL after having achieved an HIV-1 RNA below LOQ.
Measured: Baseline up to Week 24
Change in Lymphocyte Subset CD4 From Baseline
Calculated average of CD4 at Day 7, 14, 28 and Week 24 minus CD4 at Day 1
Measured: Day 1 (Baseline), Day 7, 14, 28 and Weeks 24
Change in Lymphocyte Subset CD8 From Day 1
Calculated average of CD8 at Day 7, 14, 28 and Week 24 minus CD8 at Day 1
Measured: Day 1(Baseline), Day 7, 14, 28 and Weeks 24
Change in Lymphocyte Subsets; CD4 and CD8 From Screening.
Calculated avergae of {CD4 or CD8 at Day 1 - CD4 or CD8 at Screening}
Measured: Screening (Day -14 to 0), Day 1.
Change in Detectable Tropism From Screening
Number of subjects who switch their tropism status from screening to Baseline
Measured: Screening (Day -21 to 0), Baseline.
Change in Detectable Tropism From Baseline
Number of subjects who switch their tropism status from Baseline to Days 7, 14, and Week 24/End of Study(EOS)/Discontinuation
Measured: Baseline, Day 15 and Week 24/End of Study/Discontinuation
Change in Detectable Resistance (Genotype) and Susceptibility (Phenotype) to Drugs in the Regimen From Screening
Change in detectable resistance (genotype) and susceptibility (phenotype) to drugs in the regimen from Screening
Measured: Screening (Day -21), Baseline (Day 0), Day 14 (after addition of MVC to a failing regimen), Week 24, and time of Virologic Failure.
Number of Subjects With Susceptibility to Maraviroc
Phenotypic susceptibility to maraviroc
Measured: Screening (Day -21 to 0), Day 14, Week 24
Change in Gene Sequence in Gp-160, and the V3 Loop From Screening Visit (Day -21 to 0) to Day 14, Time of Virologic Failure (See Section 6.5.1) and Week 24
Change in gene sequence in gp-160, and the V3 loop from Screening visit (Day -21 to 0) to Day 14, time of virologic failure (See Section 6.5.1) and Week 24
Measured: Screening (Day -21 to 0), Day 14, time of virologic failure, and Week 24
Correlation of Mutations in gp160 and the V3 Loop and Decreased Susceptibility to Maraviroc
Measured: Screening (Day -21 to 0), Day 14, time of virologic failure, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionOct 2008
- Study completionOct 2008
Why it stopped: See Detailed Description
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 ViiV HealthcareThe 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 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00496782
- Sponsor's protocol ID
- A4001060
- Status last verified
- Jan 2019
- First submitted
- 3 Jul 2007
- Last updated
- 30 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surrogate Marker For Tropism-A Multi-Center, Open Label, Pilot Study
- ClinicalTrials.gov ID
- NCT00496782
- Acronym / sponsor ID
- A4001060
- Conditions
- HIV Infections
- Keywords
- Treatment Experienced
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See Detailed Description
- Enrolment
- 16 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Jul 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 4 Jul 2007 (estimated)
- Results
- Posted 19 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to determine whether there is a correlation between viral load reduction (at Day 4, 7 or 14) following a short course (14 days) of Maraviroc added to a failing regimen, and the R5 result of the TrofileTM assay at screening.
Detailed description
The study A4001060 has been discontinued on April 22, 2008. A review of the poor rate of enrollment has projected difficulties in completing the study in a timely manner, despite the best efforts by the sponsor and the sites. Given the difficulties encountered in this pilot study and the need to conduct an even larger confirmatory study, the decision to discontinue the study has therefore been made. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single | Other | Drug: maraviroc, Procedure: Trofile Assay and HIV RNA quantification assay |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 16 years of age (or minimum adult age as determined by local regulatory authorities or as dictated by local law) at the screening visit.
- Have an HIV RNA ≥ 1000 copies/mL, at screening.
- Subjects receiving another investigational antiretroviral compound through participation in a phase 3 or 4 clinical study are eligible to participate in this trial provided.
- That the 2 investigational agents are required to offer the subject a regimen with 2 or 3 active antiretroviral drugs (i.e. one or fewer approved treatment is available to the subject due to prior resistance or intolerance),
- Neither protocol prohibits the use of the other antiretroviral agent, AND the dosing of the two agents when used together is known AND a letter from the Pfizer clinical pharmacologists for maraviroc identifies the dose of maraviroc to be used with other investigational agents.
Key exclusion criteria (3 listed)
- Potentially life threatening (Grade 4) laboratory abnormality or medical condition.
- Severe hepatic impairment (Child-Pugh classification B or C).
- End stage renal disease or other disease states requiring dialysis therapy.
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 |
|---|---|---|
| maravirocTreatment-experienced subjects on failed therapy, with HIV RNA ≥ 1000 copies/mL, are eligible who will receive a tropism assay at screening (Day -14 to 0). Subjects who are eligible will receive maraviroc added to a failing regimen from Day 1 to 14. On day 15, subjects will discontinue the current treatment regimen and begin a new OBT. Subjects with only R5 HIV will continue receiving maraviroc plus OBT. Subjects with non-R5 virus will discontinue receiving maraviroc but continue to receive the new OBT. Investigator selects OBT based on results of phenotype/genotype testing at baseline. The nominal dose for maraviroc is 300 mg BID. The maraviroc dose should be adjusted based on OBT patient is taking. If OBT includes CYP3A4 inhibitor (with or without inducers) maraviroc dose should be 150 mg BID and if OBT includes CYP3A4 inducer (without inhibitors) maraviroc dose should be 600mg BID. If OBT does not include any CYP3A4 inducers or inhibitors maraviroc dose should be 300 mg BID. | Drug | Single |
| Trofile Assay and HIV RNA quantification assayTrofile Assay and HIV RNA quantification assay | Procedure or surgery | Single |
Primary outcome
Change From Baseline in Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) With R5 & Non-R5 Tropism Results From the Trofile(tm) Assay
Time frame: Baseline, Day 4, 7, 14
Spearman's correlation coefficient to assess percentage of participants achieving HIV-1 RNA with tropism
13 secondary outcomes
Subjects Achieving HIV-1 RNA <400 Copies/mL
Time frame: Days 4, 7, 14, 28, and Weeks 8, 12, 18, and 24
Subjects Achieving HIV-1 RNA <50 Copies/mL
Time frame: Days 4, 7, 14, 28, and Weeks 8, 12, 18, and 24
Subjects With Virologic Failure
Time frame: Baseline up to Week 24
Time to Virologic Failure
Time frame: Baseline up to Week 24
Change in Lymphocyte Subset CD4 From Baseline
Time frame: Day 1 (Baseline), Day 7, 14, 28 and Weeks 24
Change in Lymphocyte Subset CD8 From Day 1
Time frame: Day 1(Baseline), Day 7, 14, 28 and Weeks 24
Change in Lymphocyte Subsets; CD4 and CD8 From Screening.
Time frame: Screening (Day -14 to 0), Day 1.
Change in Detectable Tropism From Screening
Time frame: Screening (Day -21 to 0), Baseline.
Change in Detectable Tropism From Baseline
Time frame: Baseline, Day 15 and Week 24/End of Study/Discontinuation
Change in Detectable Resistance (Genotype) and Susceptibility (Phenotype) to Drugs in the Regimen From Screening
Time frame: Screening (Day -21), Baseline (Day 0), Day 14 (after addition of MVC to a failing regimen), Week 24, and time of Virologic Failure.
Number of Subjects With Susceptibility to Maraviroc
Time frame: Screening (Day -21 to 0), Day 14, Week 24
Change in Gene Sequence in Gp-160, and the V3 Loop From Screening Visit (Day -21 to 0) to Day 14, Time of Virologic Failure (See Section 6.5.1) and Week 24
Time frame: Screening (Day -21 to 0), Day 14, time of virologic failure, and Week 24
Correlation of Mutations in gp160 and the V3 Loop and Decreased Susceptibility to Maraviroc
Time frame: Screening (Day -21 to 0), Day 14, time of virologic failure, Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for HIV Infections
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
RecruitingEarly Phase 1
A Study of Daratumumab and Dose-Adjusted EPOCH in Plasmablastic Lymphoma
Plasmablastic Lymphoma, Ann Arbor Stage I Diffuse Large B-Cell Lymphoma
Active, not recruiting
Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda
HIV Prevention
Not yet recruiting
Bwelela Easy Study
HIV, HIV - Human Immunodeficiency Virus
RecruitingPhase 1
AMC 120, Glofitamab Plus Chemoimmunotherapy in Newly Diagnosed HIV-Associated Large B-Cell Lymphoma (The "Glofit-RCHOP Study")
AIDS-Related Diffuse Large B-cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
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.
Pfizer CT.gov Call Center study director
Pfizer
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing maraviroc and Trofile Assay and HIV RNA quantification assay in people with HIV Infections, run by ViiV Healthcare at 10 sites in 2 countries.
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 3 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: stopped early, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Mar 2010). 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 From Baseline in Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) With R5 & Non-R5 Tropism Results From the Trofile(tm) Assay (time frame: Baseline, Day 4, 7, 14). 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 30 Jan 2019.