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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


Phase 4
16 Years
N/A
Not Enrolling
Both
HIV, AIDS

Thank you

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

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