N/A
N=282,368
Kaiser Permanente HIV Cohort Study
HIV · AIDS
Bottom Line
View on ClinicalTrials.gov: NCT01339403 ↗Enrolled (actual)
282,368
Serious AEs
—
Results posted
Apr 2015
Primary outcome: Primary: Incidence Rate of Malignancies — 513; 3; 238; 20 malignancies per 100,000 person-years — p=<0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- non-interventional trial (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ViiV Healthcare
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate of Malignancies |
513; 3; 238; 20; 25; 7 | <0.001 sig |
| PRIMARY Incidence Rate of Myocardial Infarction and Ischemia |
435; 313 | <0.001 sig |
| PRIMARY Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections |
1002; 15; 760; 2; 640; 74 | <0.001 sig |
| PRIMARY Incidence Rate of Liver Failure |
492; 105 | <0.001 sig |
| PRIMARY Incidence Rate of Liver Related Death |
202; 29 | <0.001 sig |
| PRIMARY Incidence Rate of Rhabdomyolysis |
235; 28 | <0.001 sig |
| PRIMARY Incidence Rate of All-Cause Mortality |
1827; 326 | <0.001 sig |
| PRIMARY Incidence Rate of Viral Encephalitis |
30; 2 | <0.001 sig |
Summary
Human Immunodeficiency Virus (HIV) infected patients in the Kaiser Permanente HIV registry wil be followed in the usual clinical care to estimate the rates of specified clinical events. The rates will be stratified by relevant characteristics like age, CD4 counts, HIV Viral Load (VL), HIV medication history. The rates in the HIV infected cohort wil be compared with the rates of these events in patients in the Kaiser Permanente database who are not infected with HIV.
Eligibility Criteria
Inclusion Criteria
HIV infection.
Exclusion Criteria
None
Data sourced from ClinicalTrials.gov (NCT01339403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.