N/A
N=3
Safety And Efficacy Of Rescriptor In Patients For Human Immunodeficiency Virus (HIV) Patients
HIV-1 Infection
Bottom Line
View on ClinicalTrials.gov: NCT00823966 ↗Enrolled (actual)
3
Serious AEs
66.7%
Results posted
Jul 2010
Primary outcome: Primary: Number of Participants Who Reported Unlisted Adverse Drug Reaction. — 0 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Rescriptor (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Reported Unlisted Adverse Drug Reaction. |
— | — |
| PRIMARY Number of Participants Who Improved in Number of HIV- Ribonucleic Acid (RNA) Copies, Cluster of Differentiation 4(CD4) Count, and Not Progress in HIV Classification: Centers for Disease Control and Prevention Clinical Category (CDC Category). |
3; 2; 3 | — |
Summary
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the Local Product Document (LPD) (unlisted adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
Eligibility Criteria
Inclusion Criteria
Patients need to be administered Rescriptor® in order to be enrolled in the surveillance.
Exclusion Criteria
Patients not administered Rescriptor®.
Data sourced from ClinicalTrials.gov (NCT00823966). 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.