Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TMC278, Long acting · 1 trial · 1 indication
| 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...
TMC278, Long acting is an investigational long-acting small molecule formulation developed by Johnson & Johnson. It has been studied in a Phase 1 clinical trial in HIV-1 seronegative participants to evaluate its safety, acceptability, pharmacokinetics, and ex vivo pharmacodynamics. The specific indication for this long-acting formulation has not been disclosed.
TMC278, Long acting is being developed by Johnson & Johnson, which trades under the ticker JNJ. The company sponsored the Phase 1 trial of the long-acting formulation.
TMC278, Long acting is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. It is an investigational product and has not been approved by the FDA.
TMC278, Long acting has been evaluated in a single completed Phase 1 trial, NCT01656018, titled "A Study to Evaluate Safety, Acceptability, Pharmacokinetics, and ex Vivo Pharmacodynamics of TMC278 Long Acting Formulation in HIV-1 Seronegative Participants." The trial enrolled 4 healthy volunteers in the United States and was randomized and controlled.
Yes, TMC278, Long acting is also known as TMC278, Long acting (LA). The abbreviation LA stands for long-acting, referring to the same investigational formulation developed by Johnson & Johnson.