Phase 3
N=312
Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) With Darunavir/Ritonavir (DRV/r)
Human Immunodeficiency Virus (HIV)
Bottom Line
View on ClinicalTrials.gov: NCT01516970 ↗Enrolled (actual)
312
Serious AEs
0.3%
Results posted
Oct 2016
Primary outcome: Primary: Number of Participants With Early Discontinuation From Randomized Human Immunodeficiency Virus Postexposure Prophylaxis (HIV PEP) — 10; 15 participants — p=0.2434
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Darunavir/Ritonavir (DRV/r) (Drug); Lopinavir in fixed combination with Ritonavir (Drug); Zidovudine (Drug); NRTIs (Drug); Efavirenz (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen-Cilag G.m.b.H
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Early Discontinuation From Randomized Human Immunodeficiency Virus Postexposure Prophylaxis (HIV PEP) |
10; 15 | 0.2434 |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
131; 125 | 0.8839 |
| SECONDARY Worst Sheehan Disability Scale (SDS) Score for the Safety Population |
2.566; 3.503; 2.465; 3.464; 2.226; 2.954 | — |
| SECONDARY Percentage of Participants Who Developed Detectable HIV Antibodies |
99.3; 100; 0.7; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Occupational injury and non-occupational exposure with documented human immunodeficiency virus (HIV) exposure, or potential for HIV exposure
- Indication for HIV postexposure prophylaxis (PEP), as determined by the treating physician and/or the investigator
- Women must be: postmenopausal (for at least 2 years), surgically sterile, using oral contraceptives
- Willing to continue HIV PEP for 28 days
Exclusion Criteria
- Positive HIV rapid test
- History of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastro intestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Pregnant or breast-feeding
- Any condition that, in the opinion of the investigator, would compromise the well-being of the participant or the study or prevent the participant from meeting or performing study requirements
Data sourced from ClinicalTrials.gov (NCT01516970). 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.