HIV-1 infection MedDRA version: 9.1 Level: LLT Classification code 10020161 Term: HIV infection
Conditions
Interventions
Pharmaceutical Form:
Sponsors
Pfizer Inc, 235 East 42nd Street, New York, NY 10017
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. Previous participation within 42 days in a UK-453,061 Phase 2b clinical trial(specifically, Studies A5271015 or A5271022) or in a UK-453,061 Phase 3 clinical trial. 3. Male or female at least 18 years of age. 4. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=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. Unwilling or unable to be followed for the duration of the study. 2. Concurrent treatment in another clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess long-term safety for subjects who were enrolled in the UK-453,061 studies for treatment of HIV-1 infection. Patients will be followed on an ARV regimen selected by the Investigator. IMP will not be included as part of the regimen.;Secondary Objective: ;Primary end point(s): Safety assessed by adverse events. | — |
Countries
France, Germany, Italy, Poland, Spain, United Kingdom
Outcome results
None listed