HIV-1Phase 2NCT01254656
A Long Term Safety Study Of Lersivirine For The Treatment Of HIV-1 Infection In Subjects Who Have Completed Treatment With Lersivirine In Studies A5271015 And A5271022
A Phase 2 study testing lersivirine, efavirenz and etravirine in people with HIV-1, run by Pfizer at 23 sites in 9 countries.
Trial summary
This is a study to assess long-term safety and efficacy of lersivirine in patients who have completed 96 weeks of treatment with lersivirine in studies A5271015 and A5271022. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1
- What is being tested?
- lersivirine, efavirenz and etravirine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 23 sitesin 9 countries
- Study dates
- Feb 2011to Apr 2013
- Phase
- Phase 2
- 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 complete of 96 weeks of treatment with lersivirine (or comparator where required by local regulation) in one of the parent protocols (A5271015 or A5271022).
- Patients must have had a viral load less than 50 copies/mL at Week 84 of the parent protocol.
- For women who can have children, a negative urine pregnancy test at the Day 1 visit.
Who cannot join
- Patients with any Grade 4 Division of AIDS toxicity (except for lipids and asymptomatic glucose elevations will not be included in this trial.
- Patients being treated with another investigational product or in another clinical trial, except the lersivirine parent protocols will not be included in this trial.
Trial locations and contacts
23 sites in 9 countries.
23 sites in 9 countries
South Africa6 sites
Pfizer Investigational Site
Cape Town, Western Cape, 7925
Pfizer Investigational Site
Durban, KwaZulu-Natal, 4001
Pfizer Investigational Site
Johannesburg, Gauteng, 2193
Pfizer Investigational Site
Pretoria, Gauteng, 0083
Pfizer Investigational Site
Pretoria, 0083
Pfizer Investigational Site
Soweto, Gauteng, 2013
Canada3 sites
Pfizer Investigational Site
Montreal, Quebec, H2L 4P9
Pfizer Investigational Site
Montreal, Quebec, H2L 5B1
Pfizer Investigational Site
Toronto, Ontario, M5G 1K2
Switzerland3 sites
Pfizer Investigational Site
Lugano, 6903
Pfizer Investigational Site
Sankt Gallen, 9007
Pfizer Investigational Site
Zurich, 8091
United Kingdom3 sites
Pfizer Investigational Site
Brighton, East Sussex, BN2 1ES
Pfizer Investigational Site
London, NW3 2QG
Pfizer Investigational Site
London, SW10 9NH
Australia2 sites
Pfizer Investigational Site
Darlinghurst, New South Wales, 2010
Pfizer Investigational Site
Melbourne, Victoria, 3004
Italy2 sites
Pfizer Investigational Site
Milan, 20127
Pfizer Investigational Site
Torino, 10149
Poland2 sites
Pfizer Investigational Site
Bydgoszcz, 85-030
Pfizer Investigational Site
Warsaw, 01-201
Brazil1 site
Pfizer Investigational Site
Nova Iguaçu, Rio de Janeiro, 26030-381
About this study
Official title: A Long Term Open-Label Extension Study Of Lersivirine For The Treatment Of HIV-1 Infection
This is a study to assess long-term safety and efficacy of lersivirine in patients who have completed 96 weeks of treatment with lersivirine in studies A5271015 and A5271022.
Read the detailed description
The trial was terminated prematurely on January 29, 2013, due to the decision of the sponsor to discontinue development of lersivirine. The decision to terminate the trial was not based on any safety or efficacy concerns.
- Conditions
- HIV-1
- Being tested
- lersivirine, efavirenz, etravirine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lersivirineDrug
Lersivirine 500 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily
lersivirineDrug
Lersivirine 750 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily
efavirenzDrug
Efavirenz 600 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily
lersivirineDrug
Lersivirine 750 mg tablets PO taken once daily + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules PO taken twice daily + 1 optimized NRTI
lersivirineDrug
Lersivirine 1000 mg PO tablets + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules PO taken twice daily + 1 optimized NRTI
etravirineDrug
Etravirine 200 mg PO tablets + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules taken twice daily + 1 optimized NRTI
| Study group | Role | What they receive |
|---|---|---|
| LRV 500mg | Experimental | Not described Receives: Drug: lersivirine |
| LRV 750mg +TVD | Experimental | Not described Receives: Drug: lersivirine |
| EFV | Active comparator | Not described Receives: Drug: efavirenz |
| LRV 750mg+ DRV/r + OBT | Experimental | Not described Receives: Drug: lersivirine |
| LRV 1000mg +DRV/r + OBT | Experimental | Not described Receives: Drug: lersivirine |
| ETR | Active comparator | Not described Receives: Drug: etravirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Plasma Human Immunodeficiency Virus - 1 (HIV-1) Ribonucleic Acid (RNA) Level <50 Copies/mL at 144 Weeks From Day 1 of the Parent Protocol
Number of participants with HIV-1 RNA level <50 copies/mL plasma was summarized at 48 weeks i.e. 144 weeks from Day 1 of the parent protocol. Roche Amplicor HIV-1 Monitor assay was used to measure the HIV-1 RNA level.
Measured: 144 Weeks from Day 1 of the parent protocol
Secondary outcomes (6)
Number of Participants With Plasma HIV-1 RNA Level <50 Copies/mL up to Week 208
Number of participants with HIV-1 RNA level <50 copies/mL plasma was summarized at last visit. Abbott RealTime HIV-1 assay was used to measure the HIV-1 RNA level.
Measured: Up to Week 208
Change From Baseline in CD4+ Lymphocyte Counts (Absolute) at 144 Weeks From Day 1 of the Parent Protocol
Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 48 weeks (ie, 144 weeks from Day 1 of the parent protocol)
Measured: 144 Weeks from Day 1 of the parent protocol
Change From Baseline in CD4+ Lymphocyte Counts (Percentage) at 144 Weeks From Day 1 of the Parent Protocol
Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 48 weeks (ie, 144 weeks from Day 1 of the parent protocol)
Measured: 144 Weeks from Day 1 of the parent protocol
Change From Baseline in CD4+ Lymphocyte Counts (Absolute) at 192 Weeks From Day 1 of the Parent Protocol
Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 192 weeks from Day 1 of the parent protocol.
Measured: 192 Weeks from Day 1 of the parent protocol
Change From Baseline in CD4+ Lymphocyte Counts (Percentage) at 192 Weeks From Day 1 of the Parent Protocol
Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 192 weeks from Day 1 of the parent protocol.
Measured: 192 Weeks from Day 1 of the parent protocol
Virology Analysis Participant Accountability From Week 96 Through Study Termination
Virology analysis included virus susceptibility (phenotype and genotype)to a standard panel of approved antiretrovirals as determined by the Monogram Biosciences PhenoSense GT assay. Below analysis table included the following parameters: 1. "protocol-defined treatment failure" was defined as an increase in HIV-1 RNA to detectable levels (≥50 copies/mL) on 2 consecutive measurements, the second measurement taken no more than 14 days after the first measurement); 2. "Treatment failure": treatment failure (both virologic and non-virologic) was defined as a subject who met the protocol-defined treatment failure criterion or discontinued from the study; 3. "NRTI or NNRTI resistance mutations": nucleoside reverse transcriptase inhibitor or lersivirine-associated resistance-associated mutations (RAM) based on the International AIDS Society-USA (IAS-USA) RAM guidelines; 4. 'with result' meant an analyzed sample returned genotypic result or phenotypic result or both.
Measured: Week 96 through study termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2010 (estimated)
- Study startFeb 2011
- Primary completionApr 2013
- Study completionApr 2013
Why it stopped: See termination reason in 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-1Studies of the same condition, open and under way.
- More trials run by PfizerThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ViiV Healthcare
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01254656
- Sponsor's protocol ID
- A5271037
- Status last verified
- Jan 2014
- First submitted
- 3 Dec 2010
- Last updated
- 9 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long Term Open-Label Extension Study Of Lersivirine For The Treatment Of HIV-1 Infection
- ClinicalTrials.gov ID
- NCT01254656
- Acronym / sponsor ID
- A5271037
- Conditions
- HIV-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 108 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- ViiV Healthcare
- Study start
- Feb 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 6 Dec 2010 (estimated)
- Results
- Posted 9 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to assess long-term safety and efficacy of lersivirine in patients who have completed 96 weeks of treatment with lersivirine in studies A5271015 and A5271022.
Detailed description
The trial was terminated prematurely on January 29, 2013, due to the decision of the sponsor to discontinue development of lersivirine. The decision to terminate the trial was not based on any safety or efficacy concerns.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| LRV 500mg | Experimental | Drug: lersivirine |
| LRV 750mg +TVD | Experimental | Drug: lersivirine |
| EFV | Active comparator | Drug: efavirenz |
| LRV 750mg+ DRV/r + OBT | Experimental | Drug: lersivirine |
| LRV 1000mg +DRV/r + OBT | Experimental | Drug: lersivirine |
| ETR | Active comparator | Drug: etravirine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must complete of 96 weeks of treatment with lersivirine (or comparator where required by local regulation) in one of the parent protocols (A5271015 or A5271022).
- Patients must have had a viral load less than 50 copies/mL at Week 84 of the parent protocol.
- For women who can have children, a negative urine pregnancy test at the Day 1 visit.
Key exclusion criteria (2 listed)
- Patients with any Grade 4 Division of AIDS toxicity (except for lipids and asymptomatic glucose elevations will not be included in this trial.
- Patients being treated with another investigational product or in another clinical trial, except the lersivirine parent protocols will not be included in this trial.
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 |
|---|---|---|
| lersivirineLersivirine 500 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily | Drug | LRV 500mg |
| lersivirineLersivirine 750 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily | Drug | LRV 750mg +TVD |
| efavirenzEfavirenz 600 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily | Drug | EFV |
| lersivirineLersivirine 750 mg tablets PO taken once daily + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules PO taken twice daily + 1 optimized NRTI | Drug | LRV 750mg+ DRV/r + OBT |
| lersivirineLersivirine 1000 mg PO tablets + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules PO taken twice daily + 1 optimized NRTI | Drug | LRV 1000mg +DRV/r + OBT |
| etravirineEtravirine 200 mg PO tablets + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules taken twice daily + 1 optimized NRTI | Drug | ETR |
Primary outcome
Number of Participants With Plasma Human Immunodeficiency Virus - 1 (HIV-1) Ribonucleic Acid (RNA) Level <50 Copies/mL at 144 Weeks From Day 1 of the Parent Protocol
Time frame: 144 Weeks from Day 1 of the parent protocol
Number of participants with HIV-1 RNA level <50 copies/mL plasma was summarized at 48 weeks i.e. 144 weeks from Day 1 of the parent protocol. Roche Amplicor HIV-1 Monitor assay was used to measure the HIV-1 RNA level.
6 secondary outcomes
Number of Participants With Plasma HIV-1 RNA Level <50 Copies/mL up to Week 208
Time frame: Up to Week 208
Change From Baseline in CD4+ Lymphocyte Counts (Absolute) at 144 Weeks From Day 1 of the Parent Protocol
Time frame: 144 Weeks from Day 1 of the parent protocol
Change From Baseline in CD4+ Lymphocyte Counts (Percentage) at 144 Weeks From Day 1 of the Parent Protocol
Time frame: 144 Weeks from Day 1 of the parent protocol
Change From Baseline in CD4+ Lymphocyte Counts (Absolute) at 192 Weeks From Day 1 of the Parent Protocol
Time frame: 192 Weeks from Day 1 of the parent protocol
Change From Baseline in CD4+ Lymphocyte Counts (Percentage) at 192 Weeks From Day 1 of the Parent Protocol
Time frame: 192 Weeks from Day 1 of the parent protocol
Virology Analysis Participant Accountability From Week 96 Through Study Termination
Time frame: Week 96 through study termination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
- 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.
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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
23 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lersivirine, efavirenz and etravirine in people with HIV-1, run by Pfizer at 23 sites in 9 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 2 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 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in South Africa, Canada, Switzerland, United Kingdom, Australia and 4 more countries. 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 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?
Yes. Results are posted in the registry (first posted 9 Jun 2014). 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 Participants With Plasma Human Immunodeficiency Virus - 1 (HIV-1) Ribonucleic Acid (RNA) Level <50 Copies/mL at 144 Weeks From Day 1 of the Parent Protocol (time frame: 144 Weeks from Day 1 of the parent protocol). 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 9 Jun 2014.