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Cabotegravir once daily for 28 days · 1 trial · 2 indications
Blood samples were collected to measure cabotegravir concentration in blood plasma following a single 600 mg IM dose at indicated time-points. Evaluable Pharmacokinetic (PK) Plasma Parameter Summary Population comprised of all participants who underwent plasma PK sampling following oral dose in treatment period 1 and IM injection in treatment period 2 and had evaluable PK parameters estimated and no major protocol deviation.
Vaginal tissue samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points. Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM) comprised of all participants who underwent sampling following oral dose in treatment period 1 and IM injection in treatment period 2 and have both evaluable PK and evaluable tissues-fluid parameters estimated in vaginal tissue/cervical tissue/cervicovaginal fluid/rectal tissue/rectal fluid.
Cervical tissue samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points.
Cervicovaginal fluid samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points.
Rectal tissue samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points.
Rectal fluid samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points.
| Arm | Type | Description |
|---|---|---|
| Cabotegravir | EXPERIMENTAL | Subject will receive CAB 30 mg tablet once daily oral dose for 28 days (4 weeks) followed by a washout period of 14 to 42 days. After the washout, subject will receive a single dose of CAB LA 600 mg IM to gluteal region. |
| Name | Type | Description |
|---|---|---|
| Cabotegravir tablet 30 mg once daily for 28 days. | DRUG | GSK1265744B, lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycolate, magnesium stearate, Aquarius film-coating, white BP18237 |
| Cabotegravir injection 3 mL (200 mg/mL) IM given once on Day 1. | DRUG | Cabotegravir will be supplied as sterile suspension for injection 200 mg/mL vial. Each vial appears as sterile white to slightly colored suspension containing 200 mg/mL of CAB for administration by intramuscular (intragluteal) injection and will be administered as 1 × 3 mL Injections (3 mL \[600 mg\] total) IM given once on Day 1 of injection phase |
Inclusion Criteria: * Between 18 and 55 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monito...
Cabotegravir once daily for 28 days refers to a 30 mg oral tablet of cabotegravir taken once daily for 28 days. It is an investigational small molecule studied for human immunodeficiency virus (HIV) infection and is being developed by GSK plc (ticker: GSK).
Cabotegravir once daily for 28 days is being studied for the treatment or prevention of human immunodeficiency virus (HIV) infection. The 28-day oral regimen has been evaluated in a Phase 1 pharmacokinetic study in healthy adult volunteers, not in patients with HIV.
GSK plc, which trades under the ticker GSK, is the developer of cabotegravir once daily for 28 days. The 30 mg oral tablet regimen is part of GSK's cabotegravir program in infectious disease, focused on human immunodeficiency virus (HIV).
Cabotegravir once daily for 28 days is in Phase 1 development. It is an investigational regimen and has not been approved by the FDA for any indication. The only listed trial of this 28-day oral regimen is a completed Phase 1 pharmacokinetic study.
Cabotegravir once daily for 28 days has been studied in one completed Phase 1 trial, NCT02478463, titled "Pharmacokinetic Study of Cabotegravir Long-acting in Healthy Adult Volunteers." That trial enrolled 19 healthy adult volunteers in the United States and was an uncontrolled, non-randomized study.
Yes. Cabotegravir tablet 30 mg once daily for 28 days is another name for cabotegravir once daily for 28 days. Both refer to the same oral 30 mg once-daily regimen of cabotegravir developed by GSK plc for human immunodeficiency virus (HIV) infection.