Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01656018 | A Study to Evaluate Safety, Acceptability, Pharmacokinetics, and ex Vivo Pharmacodynamics of TMC278 Long Acting Formulation in HIV-1 Seronegative Participants | PHASE1 | COMPLETED | 4 | — | — | Nov 1, 2012 | Jan 1, 2016 | Apr 7, 2016 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Arm 1A | EXPERIMENTAL | Female participants will receive a single dose of long acting TMC278 1200 mg intramuscularly (IM) at baseline (Day 0) in Arm 1A. |
| Arm 1B | EXPERIMENTAL | Male participants will receive a single dose of long acting TMC278 1200 mg IM at baseline in Arm 1B. |
| Arm 2A | EXPERIMENTAL | Female participants will receive a single dose of long acting TMC278 600 mg IM at baseline in Arm 2A. |
| Arm 2B | EXPERIMENTAL | Male participants will receive a single dose of long acting TMC278 600 mg IM at baseline in Arm 2B. |
| Arm 3A | EXPERIMENTAL | Female participants will receive 3 bi-monthly injections of long acting TMC278 1200 mg IM at baseline, Months 2 and 4 in Arm 3A. |
| Arm 3B | EXPERIMENTAL | Male participants will receive 3 bi-monthly injections of long acting TMC278 1200 mg IM at baseline, Months 2 and 4 in Arm 3B. |
| Arm 4A | EXPERIMENTAL | Female participants will receive a single dose of long acting TMC278 1200 mg IM at baseline followed by TMC278 900 mg at Months 2 and 4 in Arm 4A. |
| Arm 4B | EXPERIMENTAL | Male participants will receive a single dose of long acting TMC278 1200 mg IM at baseline followed by TMC278 900 mg at Months 2 and 4 in Arm 4B. |
| Arm 5A | EXPERIMENTAL | Female participants will receive a single dose of long acting TMC278 1200 mg IM at baseline followed by TMC278 600 mg at Months 2 and 4 in Arm 5A. |
| Arm 5B | EXPERIMENTAL | Male participants will receive a single dose of long acting TMC278 1200 mg IM at baseline followed by TMC278 600 mg at Months 2 and 4 in Arm 5B. |
| Name | Type | Description |
|---|---|---|
| TMC278, Long acting (LA) | DRUG | TMC278 long acting will be administered IM to the participants as follows: a single dose of TMC278 600 mg will be administered at baseline in Arm 2A and Arm 2B; at Months 2 and 4 in Arm 5A and Arm 5B. A single dose of TMC278 900 mg will be administered at Months 2 and 4 in Arm 4A and Arm 4B. A single dose of TMC278 1200 mg will be administered at baseline in Arm 1A, Arm 1B; Arm 3A, Arm 3B, Arm 4A, Arm 4B, Arm 5A and Arm 5B; at Months 2 and 4 in Arm 3A and Arm 3B. |
Inclusion Criteria: * Human immunodeficiency virus type 1 (HIV-1) seronegative at screening and enrollment * Not pregnant or breastfeeding females * Agrees to protocol-defined method of contraception * Abstinence from insertion of anything in rectum (eg, medication, enema, penis, or sex toy) for 72...