Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Maraviroc+ Zidovudine/Lamivudine · 1 trial · 1 indication
Percentage of participants with viral load of less than 400 copies/mL and less than 50 copies/mL of HIV-1 RNA were not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 3 | ACTIVE_COMPARATOR | - |
| 2 | EXPERIMENTAL | Following a review of the interim analysis data, the DSMB recommended to terminate the UK-427,857 300 mg QD arm based on pre-specified protocol non-inferiority criteria not being met for the QD arm versus efavirenz |
| Name | Type | Description |
|---|---|---|
| Maraviroc + Zidovudine/Lamivudine | DRUG | maraviroc (UK-427,857) 300 mg once daily added to zidovudine/lamivudine (300 mg/150 mg twice daily) |
| Efavirenz + Zidovudine/Lamivudine | DRUG | efavirenz (600 mg once daily) added to zidovudine/lamivudine (300 mg/150 mg twice daily) |
| Maraviroc (UK-427,857) + Zidovudine/Lamivudine | DRUG | maraviroc (UK-427,857) 300 mg twice daily added to zidovudine/lamivudine (300 mg/150 mg twice daily) |
Inclusion Criteria: * Men or women at least 16 years of age (or minimum age as determined by local regulatory authorities) * HIV-1 RNA viral load of greater than or equal to 2, 000 copies/mL * A negative urine pregnancy test at the baseline visit for Women of Child Bearing Potential (WOCBP) * Effec...
Maraviroc is an investigational small molecule being studied for the treatment of Human Immunodeficiency Virus-1 (HIV-1) infections. It is being developed by GSK plc (ticker: GSK) and has completed clinical trials in patients with HIV infections, including those in Phase 2 and Phase 3 studies.
Maraviroc is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is currently in clinical development for the treatment of HIV-1 infections, with completed trials in multiple countries.
Maraviroc is in Phase 3 clinical development for the treatment of HIV-1 infections. It has completed four clinical trials, including a Phase 3 expanded access program, and is not yet approved by regulatory authorities. The drug remains investigational and is still in clinical development.
Maraviroc has completed four clinical trials, including NCT00098306 and NCT00098722, which were Phase 2 studies of Maraviroc in combination with optimized background therapy for HIV-1 infected subjects. NCT00426660 was a Phase 3 expanded access program, and NCT00643643 was a Phase 2 pharmacokinetics study.
Maraviroc is a small molecule that targets the CCR5 receptor, which is involved in HIV-1 entry into cells. By blocking this receptor, the drug aims to prevent the virus from infecting healthy cells. This mechanism is being studied in clinical trials for the treatment of HIV-1 infections.
Yes, Maraviroc is also known as UK-427,857. Clinical trials, such as NCT00098306 and NCT00098722, refer to the drug as Maraviroc (UK-427,857), confirming that these names refer to the same investigational compound being developed for HIV-1 infections.