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 27, 2014
Last verified: January 2014
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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:
- 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 ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Number of Participants With Plasma HIV‑1 RNA Level <50 Copies/mL up to Week 208 [ Time Frame: Up to Week 208 ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]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)
- 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 ] [ Designated as safety issue: No ]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)
- 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 ] [ Designated as safety issue: No ]Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 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 ] [ Designated as safety issue: No ]Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 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 ] [ Designated as safety issue: No ]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.
| Enrollment: | 108 |
| 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 (Adult, Senior) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254656
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, NW3 2QG | |
| Pfizer Investigational Site | |
| London, United Kingdom, SW10 9NH | |
Sponsors and Collaborators
Pfizer
ViiV Healthcare
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01254656 History of Changes |
| Other Study ID Numbers: | A5271037 |
| Study First Received: | December 3, 2010 |
| Results First Received: | January 21, 2014 |
| Last Updated: | May 27, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Efavirenz Etravirine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents |
Anti-Infective Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers |
ClinicalTrials.gov processed this record on September 28, 2016