Hepatitis BPhase 4NCT00782301
Maraviroc Versus Etravirine In Combination With Antiretroviral Therapy In Drug Experienced HIV And Hepatitis Co-Infected Patients
A Phase 4 study testing maraviroc and etravirine in people with Hepatitis B and Human Immunodeficiency Virus, run by ViiV Healthcare at 18 sites in 3 countries.
Trial summary
Confirm the safety of maraviroc when used as a component of combination antiretroviral therapy in HIV and Hepatitis co-infected patients. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hepatitis B, Human Immunodeficiency Virus, Hepatitis C, Chronic
- What is being tested?
- maraviroc and etravirine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 18 sitesin 3 countries
- Study dates
- Mar 2009to Feb 2010
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HIV-1 RNA viral load of ≥1000 copies/mL at the screening visit. Detectable HCV RNA levels or Hepatitis B surface antigen (HBsAg) positive. Previous antiretroviral treatment experience with at least 2 antiretroviral drug classes for ≥3 months.
- Documented resistance to an NNRTI as well as documented resistance to another antiretroviral agent.
- CCR5 tropic virus detected by the TrofileTM assay.
Who cannot join
- Suspected or documented active, untreated HIV-1 related Opportunistic Infection (OI) or other condition requiring acute therapy at the time of randomization (subjects on a stable (>1 month) secondary OI prophylaxis regimen are eligible for the study; subjects on a primary OI prophylaxis regimen of any duration are also eligible for the study).
- Prior treatment with darunavir/ritonavir, raltegravir, or another integrase inhibitor, etravirine, maraviroc or another CCR5 inhibitor for more than 14 days at any time.
- Subjects receiving treatment for chronic Hepatitis or the expected need to initiate HCV treatment within 48 weeks of randomization. (Subjects who were previously treated for Hepatitis C are eligible for the study).
- AST and/or ALT greater than 5 times the upper limit of normal (ACTG Grade 3).
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
United States15 sites
Pfizer Investigational Site
Atlanta, Georgia, 30308
Pfizer Investigational Site
Atlanta, Georgia, 30312
Pfizer Investigational Site
Bellaire, Texas, 77401
Pfizer Investigational Site
Clearwater, Florida, 33765
Pfizer Investigational Site
Conroe, Texas, 77301
Pfizer Investigational Site
Dallas, Texas, 75390
Pfizer Investigational Site
Mount Vernon, New York, 10550
Pfizer Investigational Site
New Orleans, Louisiana, 70112
Pfizer Investigational Site
Orlando, Florida, 32803
Pfizer Investigational Site
Safety Harbor, Florida, 34695
Pfizer Investigational Site
Stafford, Texas, 77477
Pfizer Investigational Site
Tulsa, Oklahoma, 74135
Pfizer Investigational Site
Wilton Manors, Florida, 33305
Pfizer Investigational Site
Worcester, Massachusetts, 01605
Pfizer Investigational Site
Worcester, Massachusetts, 01655
Canada2 sites
Pfizer Investigational Site
Toronto, Ontario, M5G 2N2
Pfizer Investigational Site
Vancouver, British Columbia, V6Z 2C7
About this study
Official title: A Multicenter, Randomized, Open, Comparative Trial Of Maraviroc Versus Etravirine Each In Combination With Darunavir/Ritonavir And Raltegravir For The Treatment Of Antiretroviral-Experienced HIV-1 Subjects Co-Infected With Hepatitis C And/Or Hepatitis B
Confirm the safety of maraviroc when used as a component of combination antiretroviral therapy in HIV and Hepatitis co-infected patients.
- Being tested
- maraviroc, etravirine
- Keywords
- HIV and Hepatitis co-infection
- Medical subject headings
- Hepatitis B, Acquired Immunodeficiency Syndrome, Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maravirocDrug
Also called Selzentry
maraviroc 150 mg. p.o. b.i.d., darunavir 600 mg. p.o. b.i.d., ritonavir 100 mg. p.o. b.i.d., raltegravir 400 mg. p.o. b.i.d.
etravirineDrug
etravirine 200 mg. p.o. b.i.d., darunavir 600 mg. p.o. b.i.d., ritonavir 100 mg. p.o. b.i.d., raltegravir 400 mg. p.o. b.i.d.
| Study group | Role | What they receive |
|---|---|---|
| Maraviroc | Active comparator | Not described Receives: Drug: maraviroc |
| Etravirine | Active comparator | Not described Receives: Drug: etravirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with Grade 3 and Grade 4 ALT test abnormalities associated with a change from baseline ALT ≥100 IU/L through Week 48.
Measured: 48 weeks
Secondary outcomes (9)
Percentage of HCV treated subjects with Grade 3 and Grade 4 ALT test abnormalities associated with a change from baseline ALT ≥100 IU/L through 96.
Measured: 48 weeks
Time to development of Grade 3 and Grade 4 ALT test abnormalities associated with a change from baseline ALT ≥100 IU/L.
Measured: 96 weeks
Percentage of subjects with Hy's law abnormalities through Week 48.
Measured: 48 weeks
Percentage of HCV treated subjects with Hy's law abnormalities through Week 96.
Measured: 96 weeks
Change from baseline in mean Hepatitis C viral load through Week 48
Measured: 48 weeks
Undetectable HCV viral load 24 weeks after stopping HCV treatment.
Measured: 240 weeks
Percentage of subjects with HIV-1 RNA levels <48 copies/mL at Week 48.
Measured: 48 weeks
Change from baseline in CD4+ cell count at Week 48.
Measured: 48 weeks
Change from baseline in mean hepatitis B DNA through Week 48
Measured: 48 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startMar 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT00782301
- Sponsor's protocol ID
- A4001080
- Status last verified
- Jan 2012
- First submitted
- 29 Oct 2008
- Last updated
- 19 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open, Comparative Trial Of Maraviroc Versus Etravirine Each In Combination With Darunavir/Ritonavir And Raltegravir For The Treatment Of Antiretroviral-Experienced HIV-1 Subjects Co-Infected With Hepatitis C And/Or Hepatitis B
- ClinicalTrials.gov ID
- NCT00782301
- Acronym / sponsor ID
- A4001080
- Keywords
- HIV and Hepatitis co-infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Mar 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 31 Oct 2008 (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.
Confirm the safety of maraviroc when used as a component of combination antiretroviral therapy in HIV and Hepatitis co-infected patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maraviroc | Active comparator | Drug: maraviroc |
| Etravirine | Active comparator | Drug: etravirine |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- HIV-1 RNA viral load of ≥1000 copies/mL at the screening visit. Detectable HCV RNA levels or Hepatitis B surface antigen (HBsAg) positive. Previous antiretroviral treatment experience with at least 2 antiretroviral drug classes for ≥3 months.
- Documented resistance to an NNRTI as well as documented resistance to another antiretroviral agent.
- CCR5 tropic virus detected by the TrofileTM assay.
Key exclusion criteria (4 listed)
- Suspected or documented active, untreated HIV-1 related Opportunistic Infection (OI) or other condition requiring acute therapy at the time of randomization (subjects on a stable (>1 month) secondary OI prophylaxis regimen are eligible for the study; subjects on a primary OI prophylaxis regimen of any duration are also eligible for the study).
- Prior treatment with darunavir/ritonavir, raltegravir, or another integrase inhibitor, etravirine, maraviroc or another CCR5 inhibitor for more than 14 days at any time.
- Subjects receiving treatment for chronic Hepatitis or the expected need to initiate HCV treatment within 48 weeks of randomization. (Subjects who were previously treated for Hepatitis C are eligible for the study).
- AST and/or ALT greater than 5 times the upper limit of normal (ACTG Grade 3).
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 |
|---|---|---|
| maravirocAlso: Selzentrymaraviroc 150 mg. p.o. b.i.d., darunavir 600 mg. p.o. b.i.d., ritonavir 100 mg. p.o. b.i.d., raltegravir 400 mg. p.o. b.i.d. | Drug | Maraviroc |
| etravirineetravirine 200 mg. p.o. b.i.d., darunavir 600 mg. p.o. b.i.d., ritonavir 100 mg. p.o. b.i.d., raltegravir 400 mg. p.o. b.i.d. | Drug | Etravirine |
Primary outcome
Percentage of subjects with Grade 3 and Grade 4 ALT test abnormalities associated with a change from baseline ALT ≥100 IU/L through Week 48.
Time frame: 48 weeks
9 secondary outcomes
Percentage of HCV treated subjects with Grade 3 and Grade 4 ALT test abnormalities associated with a change from baseline ALT ≥100 IU/L through 96.
Time frame: 48 weeks
Time to development of Grade 3 and Grade 4 ALT test abnormalities associated with a change from baseline ALT ≥100 IU/L.
Time frame: 96 weeks
Percentage of subjects with Hy's law abnormalities through Week 48.
Time frame: 48 weeks
Percentage of HCV treated subjects with Hy's law abnormalities through Week 96.
Time frame: 96 weeks
Change from baseline in mean Hepatitis C viral load through Week 48
Time frame: 48 weeks
Undetectable HCV viral load 24 weeks after stopping HCV treatment.
Time frame: 240 weeks
Percentage of subjects with HIV-1 RNA levels <48 copies/mL at Week 48.
Time frame: 48 weeks
Change from baseline in CD4+ cell count at Week 48.
Time frame: 48 weeks
Change from baseline in mean hepatitis B DNA through Week 48
Time frame: 48 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 19 Jan 2012.
- To obtain contact information for a study center near you, click here.Link 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.
Pfizer CT.gov Call Center study director
Pfizer
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing maraviroc and etravirine in people with Hepatitis B and Human Immunodeficiency Virus, run by ViiV Healthcare at 18 sites in 3 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 3 inclusion and 4 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 19 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Canada, Poland. 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 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?
Percentage of subjects with Grade 3 and Grade 4 ALT test abnormalities associated with a change from baseline ALT ≥100 IU/L through 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 19 Jan 2012.