drugset / Trial / NCT01516970
Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) With Darunavir/Ritonavir (DRV/r)
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary purpose of this study is to assess the rate of early discontinuation from randomized Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) for any reason other than confirmation of the negative HIV infection status of the index person in patients receiving HIV PEP for at least 28 and a maximum of 30 days.
Timeline
- Start
- 2011-11-25
- Primary completion
- 2013-08-01
- Completion
- 2013-09-28
Outcome
Missed primary endpoint
registry The discontinuation rates were compared with a statistical test (Cochran-Mantel-Haenszel \[CMH\]-Test) with p-value: 0.2434 NCT01516970 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darunavir | Small molecule | 800 mg | Oral |
| Comparator | Efavirenz | Other / unclassified | 600 mg | Oral |
| Comparator | Lopinavir | Other / unclassified | 400 mg | Oral |
| Background | Zidovudine | Small molecule | 250 mg | Oral |
| Background | Lamivudine | Other / unclassified | — | — |
| Comparator | Ritonavir | Other / unclassified | 100 mg | Oral |
| Background | Tenofovir | Small molecule | — | — |
| Background | Zidovudine | Small molecule | — | — |
| Background | emtricitabine | Other / unclassified | — | — |