Treatment of HIV-1 infection in combination with other agents in antiretroviral treatment naive and antiretroviral treatment-experienced subjects. MedDRA version: 12.1 Level: LLT Classification code 10068341 Term: HIV-1 infection
Conditions
Interventions
Product Name: Lersivirine
Product Code: UK-453,061
Pharmaceutical Form: Tablet
INN or Proposed INN: Lersivirine
CAS Number: 473921-12-9
Current Sponsor code: UK-453,061
Other descriptive name: 5-[[3,5
Sponsors
Pfizer Inc., 235 East 42nd Street, New York, NY 10017
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. 2. Completion of 96 weeks of treatment with lersivirine (or comparator where required by local regulation) in one of the parent protocols. 3. HIV-1 RNA level =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following will not be included in the study: 1. Presence of any Grade 4 Division of AIDS (DAIDS) toxicity (except for lipids and asymptomatic glucose elevations and those discussed and agreed by the investigator and the Sponsor’s Medical Monitor prior to enrollment). 2. Use of prohibited concomitant medications, as defined in Section 5.5, Concomitant Medications. 3. Concurrent treatment with another investigational product or in another clinical trial, except the lersivirine parent protocols. 4. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and/or in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the long-term safety and efficacy of lersivirine in subjects who have completed treatment with lersivirine in the parent protocols.;Secondary Objective: None;Primary end point(s): > Safety and tolerability of lersivirine as measured by adverse event reports and safety laboratory tests. > 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). | — |
Countries
Italy, Portugal, United Kingdom
Outcome results
None listed