Nonrandomized, prospective, observational, multi-site registry to assess long-term safety, clinical outcome, deaths, and evolution of viral tropism in HIV subjects who completed or discontinued participation in Phase 2 or 3 clinical trials involving vicriviroc. Subjects will be followed for up to 5 years.
A non-probability sampling method will be used. Subjects will be requested to enroll in the registry after having completed or discontinued participation in a Phase 2 or 3 study involving vicriviroc.
Study Type
OBSERVATIONAL
Enrollment
180
Follow-up for subjects who previously received 30 mg tablet administered once daily according to the parent protocol.
Follow-up for subjects who previously received 20 mg tablet administered once daily according to the parent protocol.
Follow-up for subjects who previously received placebo tablet administered once daily according to the parent protocol.
Incidence of malignancies, AIDS-defining events, other clinical events of importance, and death.
Time frame: Information regarding clinical outcome will be collected every 6 months. Deaths will be collected on an ongoing basis.
Incidence of change in plasma viral tropism, time to change in plasma viral tropism, and change in HIV RNA and CD4+ counts, if available.
Time frame: Every 6 months.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Follow-up for subjects who previously received active control consisting of emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg combination tablet administered once daily according to the parent protocol.