HIV-1Phase 2NCT00824369
A Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1
A Phase 2 study testing No drug will be administered in people with HIV-1, run by Pfizer at 27 sites in 12 countries.
Trial summary
The purpose of the protocol is to assess long-term safety and tolerability of subjects who discontinue for any reason from UK-453,061 qualifying studies. 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?
- No drug will be administered
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 27 sitesin 12 countries
- Study dates
- Jul 2009to Jul 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
- Previous participation in a qualifying study.
- Male or female at least 18 years of age available for a follow-up period of at least 96 weeks.
Who cannot join
- Concurrent treatment in another clinical trial.
- Unwilling or unable to be followed for 12 months
Trial locations and contacts
27 sites in 12 countries.
27 sites in 12 countries
United States6 sites
Pfizer Investigational Site
Atlanta, Georgia, 30308
Pfizer Investigational Site
Cincinnati, Ohio, 45267
Pfizer Investigational Site
Dallas, Texas, 75235
Pfizer Investigational Site
Miami, Florida, 33137
Pfizer Investigational Site
Sacramento, California, 95814
Pfizer Investigational Site
Sacramento, California, 95817
Brazil4 sites
Pfizer Investigational Site
Campinas, São Paulo, 13015-080
Pfizer Investigational Site
Curitiba, Paraná, 80240-280
Pfizer Investigational Site
Nova Iguaçu, Rio de Janeiro, 26030-381
Pfizer Investigational Site
São Paulo, São Paulo, 04121-000
United Kingdom4 sites
Pfizer Investigational Site
Edinburgh, EH3 9HA
Pfizer Investigational Site
Edinburgh, EH4 2XU
Pfizer Investigational Site
London, SW10 9NH
Pfizer Investigational Site
Manchester, M8 5RB
Portugal2 sites
Pfizer Investigational Site
Lisbon, 1349-019
Pfizer Investigational Site
Porto, 4200-319
Puerto Rico2 sites
Pfizer Investigational Site
Ponce, 00717-1563
Pfizer Investigational Site
Santurce, 00909
South Africa2 sites
Pfizer Investigational Site
Cape Town, Western Cape, 7925
Pfizer Investigational Site
Dundee, KwaZulu-Natal, 3000
Switzerland2 sites
Pfizer Investigational Site
Lugano, 6903
Pfizer Investigational Site
Sankt Gallen, 9007
About this study
Official title: A Phase 2b Open-Label Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1 Infected Subjects
The purpose of the protocol is to assess long-term safety and tolerability of subjects who discontinue for any reason from UK-453,061 qualifying studies.
Read the detailed description
To assess long term safety and tolerability of subjects who discontinue for any reason from UK-453,061 studies. The study will also assess efficacy of the subsequent regimens in these patients. 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
- No drug will be administered
- Keywords
- HIV-1, Rollover, Safety., HIV Infections, 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.
No drug will be administeredDrug
No drug will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Anti-retroviral therapy | No intervention | Anti-retroviral therapy Receives: Drug: No drug will be administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events
The numbers of participants with treatment emergent adverse events, serious adverse events or discontinuation due to adverse events was reported.
Measured: End of Study visit or the Early Termination visit
Secondary outcomes (4)
Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit
Number of participants with HIV-1 RNA level <50 copies/mL plasma was noted at baseline, month 6, month 12 and last visit.
Measured: Baseline, Month 6, Month 12 and Last visit
Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit
Number of participants with HIV-1 RNA level <50 copies/mL plasma or below the lower limit of quantification (LLOQ) of the Assay were noted at Baseline, Month 6, Month 12 and Last visit. The lower limit of quantification (LLOQ) of the HIV 1 RNA assays ranged from 20 to 70 copies/mL as the assay was performed by local labs.
Measured: Baseline, Month 6, Month 12 and Last visit
Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12
Participant's immunological status assessed by CD4+ lymphocyte count.
Measured: Baseline, Month 6 and Month 12
CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12
Participant's immunological status assessed by CD4+ lymphocyte count.
Measured: Baseline, Month 6 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2013
- Study completionJul 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 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
- NCT00824369
- Sponsor's protocol ID
- A5271038
- Status last verified
- Jul 2014
- First submitted
- 15 Jan 2009
- Last updated
- 4 Aug 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 4 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b Open-Label Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1 Infected Subjects
- ClinicalTrials.gov ID
- NCT00824369
- Acronym / sponsor ID
- A5271038
- Conditions
- HIV-1
- Keywords
- HIV-1, Rollover, Safety., HIV Infections, treatment experienced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 52 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- ViiV Healthcare
- Study start
- Jul 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 16 Jan 2009 (estimated)
- Results
- Posted 4 Aug 2014
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 the protocol is to assess long-term safety and tolerability of subjects who discontinue for any reason from UK-453,061 qualifying studies.
Detailed description
To assess long term safety and tolerability of subjects who discontinue for any reason from UK-453,061 studies. The study will also assess efficacy of the subsequent regimens in these patients. 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-retroviral therapy | No intervention | Drug: No drug will be administeredAnti-retroviral therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Previous participation in a qualifying study.
- Male or female at least 18 years of age available for a follow-up period of at least 96 weeks.
Key exclusion criteria (2 listed)
- Concurrent treatment in another clinical trial.
- Unwilling or unable to be followed for 12 months
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 |
|---|---|---|
| No drug will be administeredNo drug will be administered. | Drug | Anti-retroviral therapy |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events
Time frame: End of Study visit or the Early Termination visit
The numbers of participants with treatment emergent adverse events, serious adverse events or discontinuation due to adverse events was reported.
4 secondary outcomes
Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit
Time frame: Baseline, Month 6, Month 12 and Last visit
Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit
Time frame: Baseline, Month 6, Month 12 and Last visit
Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12
Time frame: Baseline, Month 6 and Month 12
CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12
Time frame: Baseline, Month 6 and Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 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
27 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing No drug will be administered in people with HIV-1, run by Pfizer at 27 sites in 12 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 2 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 4 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Brazil, United Kingdom, Portugal, Puerto Rico and 7 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 4 Aug 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 Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events (time frame: End of Study visit or the Early Termination visit). 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 4 Aug 2014.