Phase 3
Completed N=482
A Trial With TMC278-TIDP6-C222 for Continued TMC278 Access in Patients Infected With Human Immunodeficiency Virus-1
Source: ClinicalTrials.gov NCT01266902 ↗Enrolled (actual)
482
Serious AEs
5.2%
Results posted
Mar 2021
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) — 32; 70 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of the study is to provide continued access to TMC278 in HIV-1 infected patients who were randomized and treated with TMC278 in the Phase IIb or Phase III trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
32; 70 | — |
| PRIMARY Number of Participants With Grade 3/4 Events of Rash Irrespective of Causality |
0; 0 | — |
| SECONDARY Time to Virologic Rebound |
1670.6; 1939.3; 1901.3; 1877.3 | — |
| SECONDARY Time To Treatment Failure |
1795.7; 1694.1; 1868.7; 1637.5 | — |
| SECONDARY Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count for Observed Case Approach Until Week 336 |
72.63; 55.91; 148.76; 132.73; 122.29; 101.50 | — |
| SECONDARY Change From Baseline in CD4+ Cell Count for Non-Completer Equals Failure (NC=F) Approach Until Week 336 |
69.76; 42.19; 133.56; 91.69; 92.12; 63.33 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) |
9; 14 | — |
| SECONDARY Number of Participants With AEs Related to Rilpivirine (RPV) |
7; 16 | — |
Eligibility Criteria
Inclusion Criteria
- Patients are HIV-1 infected and were previously randomized to receive TMC278 in a TMC278 clinical trial and completed the protocol-defined treatment period.
- Patients continue to benefit from treatment with TMC278 in the opinion of the investigator.
- Patient can comply with the current protocol requirements.
- The patient's general medical condition, in the investigator's opinion, does not interfere with participation in the trial.
Exclusion Criteria
- Use of disallowed concomitant therapy.
- Females of childbearing potential who are pregnant, or without the use of effective birth control methods, or not willing to continue practicing these birth control methods during the trial and for at least 1 month after the end of the trial (or last intake of TMC278).
- Non-vasectomized heterosexually active male patients without the use of effective birth control methods or not willing to continue practicing these birth control methods during the trial and for at least 1 month after the end of the trial (or after last intake of TMC278).
Data sourced from ClinicalTrials.gov (NCT01266902). 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.