Trial Information
Incidence And Risk Factors For Acquired Immune Deficiency Syndrome (AIDS) Defining And Non-AIDS Defining Malignancies, And Other AIDS Defining Illnesses In The EuroSIDA Study
All patients in EuroSIDA cohort that meet the entry criteria of MOTIVATE trials are included
without any sampling.
Inclusion Criteria:
- Patient aged over 16 at baseline.
- Viral Load (VL) > 5000 copies/ml at baseline (and measured in 6 months prior to
baseline).
- No changes in antiretroviral (ARV) regimens in the month period prior to baseline, or
on no ARVs in the month prior to baseline.
- > 3 months exposure (sequential or cumulative) to at least 3 of the following;
- Any nucleoside or nucleotide reverse transcriptase inhibitor (NRTI)
- Non-nucleoside reverse transcriptase inhibitor (NNNRTI)
- Protease Inhibitor (PI )
- Enfuvirtide
Exclusion Criteria:
None
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Retrospective
Outcome Measure:
Malignancy
Outcome Time Frame:
Median follow up of 3 years
Safety Issue:
Yes
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A4001104
NCT ID:
NCT01329783
Start Date:
April 2007
Completion Date:
March 2011
Related Keywords:
- HIV
- AIDS
- Acquired Immunodeficiency Syndrome
- HIV Infections