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Also known as TMC278, Long acting (LA)
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 healthy HIV-1 seronegative participants, not in patients with HIV infection. The formulation is designed to release drug over an extended period rather than requiring frequent dosing.
TMC278, Long acting is developed by Johnson & Johnson, which trades under the ticker JNJ. The company sponsored the clinical study of the long-acting formulation in healthy volunteers.
TMC278, Long acting is in Phase 1 development. It is investigational and has not been approved by the FDA. The single completed Phase 1 trial evaluated safety, acceptability, pharmacokinetics, and ex vivo pharmacodynamics in healthy HIV-1 seronegative participants.
TMC278, Long acting has been studied in one completed Phase 1 trial, NCT01656018, titled a study to evaluate safety, acceptability, pharmacokinetics, and ex vivo pharmacodynamics of the TMC278 long acting formulation in HIV-1 seronegative participants. The trial enrolled 4 participants in the United States and was controlled and randomized.
Yes. TMC278, Long acting and TMC278, Long acting (LA) refer to the same investigational formulation from Johnson & Johnson. The LA abbreviation stands for long acting, describing the extended-release design of this small molecule product.