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
This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Pfizer
Collaborator:
ViiV Healthcare
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01254656
First received: December 3, 2010
Last updated: May 21, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV-1 |
Drug: lersivirine Drug: efavirenz Drug: etravirine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Long Term Open-Label Extension Study Of Lersivirine For The Treatment Of HIV-1 Infection |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Safety and tolerability of lersivirine as measured by adverse event reports and safety laboratory tests. [ Time Frame: 240 weeks ] [ Designated as safety issue: Yes ]
- The percentage of subjects with HIV-1 RNA level <50 copies/mL at 48 weeks (ie, 144 weeks from Day 1 of the parent protocol). [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- The percentage of subjects with HIV-1 RNA level <50 copies/mL when all subjects entered in the study from a given parent protocol have reached the end of study. [ Time Frame: 240 weeks ] [ Designated as safety issue: Yes ]
- Change from baseline in CD4+ lymphocyte counts (absolute and percentage) at 48 weeks (ie, 144 weeks from Day 1 of the parent protocol) and when all subjects entered in the study from a given parent protocol have reached the end of study. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
- Genotypic and phenotypic susceptibility. [ Time Frame: At the time of protocol defined treatment failure ] [ Designated as safety issue: Yes ]
| Enrollment: | 110 |
| Study Start Date: | February 2011 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: LRV 500mg |
Drug: lersivirine
Lersivirine 500 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily
|
| Experimental: LRV 750mg +TVD |
Drug: lersivirine
Lersivirine 750 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily
|
| Active Comparator: EFV |
Drug: efavirenz
Efavirenz 600 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily
|
| Experimental: LRV 750mg+ DRV/r + OBT |
Drug: lersivirine
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
|
| Experimental: LRV 1000mg +DRV/r + OBT |
Drug: lersivirine
Lersivirine 1000 mg PO tablets + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules PO taken twice daily + 1 optimized NRTI
|
| Active Comparator: ETR |
Drug: etravirine
Etravirine 200 mg PO tablets + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules taken twice daily + 1 optimized NRTI
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254656
Locations
| Australia, New South Wales | |
| Pfizer Investigational Site | |
| Darlinghurst, New South Wales, Australia, 2010 | |
| Australia, Victoria | |
| Pfizer Investigational Site | |
| Melbourne, Victoria, Australia, 3004 | |
| Brazil | |
| Pfizer Investigational Site | |
| Nova Iguacu, RJ, Brazil, 26030-381 | |
| Canada, Ontario | |
| Pfizer Investigational Site | |
| Toronto, Ontario, Canada, M5G 1K2 | |
| Canada, Quebec | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H2L 4P9 | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H2L 5B1 | |
| Italy | |
| Pfizer Investigational Site | |
| Milano, Italy, 20127 | |
| Pfizer Investigational Site | |
| Torino, Italy, 10149 | |
| Mexico | |
| Pfizer Investigational Site | |
| Mexico, Distrito Federal, Mexico, 14050 | |
| Poland | |
| Pfizer Investigational Site | |
| Bydgoszcz, Poland, 85-030 | |
| Pfizer Investigational Site | |
| Warszawa, Poland, 01-201 | |
| South Africa | |
| Pfizer Investigational Site | |
| Johannesburg, Gauteng, South Africa, 2193 | |
| Pfizer Investigational Site | |
| Pretoria, Gauteng, South Africa, 0083 | |
| Pfizer Investigational Site | |
| Soweto, Gauteng, South Africa, 2013 | |
| Pfizer Investigational Site | |
| Durban, Kwazulu-Natal, South Africa, 4001 | |
| Pfizer Investigational Site | |
| Cape Town, Western Cape, South Africa, 7925 | |
| Pfizer Investigational Site | |
| Pretoria, South Africa, 0083 | |
| Switzerland | |
| Pfizer Investigational Site | |
| Lugano, Switzerland, 6903 | |
| Pfizer Investigational Site | |
| St. Gallen, Switzerland, 9007 | |
| Pfizer Investigational Site | |
| Zuerich, Switzerland, 8091 | |
| United Kingdom | |
| Pfizer Investigational Site | |
| Brighton, East Sussex, United Kingdom, BN2 1ES | |
| Pfizer Investigational Site | |
| London, United Kingdom, SW10 9NH | |
| Pfizer Investigational Site | |
| London, United Kingdom, NW3 2QG | |
Sponsors and Collaborators
Pfizer
ViiV Healthcare
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01254656 History of Changes |
| Other Study ID Numbers: | A5271037 |
| Study First Received: | December 3, 2010 |
| Last Updated: | May 21, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Efavirenz Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 21, 2013