N/A
Completed N=7,124
Post-Licensure Safety Study of ISENTRESS™ (Raltegravir) in a United States Managed Care Network (MK-0518-268)
HIV-1 Infections
Source: ClinicalTrials.gov NCT01078246 ↗
Enrolled (actual)
7,124
Serious AEs
—
Results posted
Apr 2016
Primary outcomePrimary: Incidence of AIDS-defining and Non-AIDS-defining Malignancy — 13.0; 8.9; 9.3; 18.2 Events per 1000 person-years of followup — p=0.002
Summary
The objective of this study is to monitor Health Outcomes of Interest (HOI) in participants with human immunodeficiency virus-1 (HIV-1) infection following treatment with Raltegravir.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of AIDS-defining and Non-AIDS-defining Malignancy |
13.0; 8.9; 9.3; 18.2; 9.1; 10.3 | 0.002 sig |
| PRIMARY Incidence of Clinically Important Hepatic Events |
19.0; 25.0; 17.1 | 0.255 |
| PRIMARY Incidence of Clinically Important Skin Events |
40.6; 69.8; 63.6 | 0.897 |
| PRIMARY Incidence of Clinically Important Muscle Events |
3.4; 3.3; 1.5 | — |
| PRIMARY Incidence of Lipodystrophy |
20.6; 35.6; 9.2 | <0.0001 sig |
| SECONDARY Incidence of Clinically Important Cardiovascular Events |
6.7; 6.4; 4.0 | 0.423 |
| SECONDARY Incidence of All-cause Mortality |
16.9; 18.4; 7.7 | 0.109 |
Eligibility Criteria
Inclusion Criteria
- Historical Cohort: HIV-infected participant treated with antiretroviral therapy in the course of ordinary clinical practice at the clinics and medical centers of Kaiser Permanente (KP) between 1 January 2000 and 12 October 2007 (date of market authorization for raltegravir in USA)
- Raltegravir Cohort: HIV-infected participant treated with raltegravir in the course of ordinary clinical practice at the clinics and medical centers of KP on or after 12 October 2007
- Concurrent Cohort: HIV-infected participant treated with a new non-raltegravir antiretroviral therapy in the course of ordinary clinical practice at the clinics and medical centers of KP on or after 12 October 2007
- All participants must have at least one year of continuous membership with KP prior to date when the participant received the first dispensed prescription for study drug (index date) to allow for the assessment of medical and treatment history
Exclusion Criteria
- Less than 18 years of age
- Do not receive their medications through the KP pharmacy system
- Do not receive their laboratory examinations through the KP system
- Participating in the raltegravir phase III or expanded access program
Data sourced from ClinicalTrials.gov (NCT01078246). 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. Informational only — not medical advice.